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A Guide to EU Pharma Regulatory Compliance: Everything You Need to Know

Date: April, 2024 | Category: Compliance | Author: Hana Trokic

Understanding the complex regulatory compliance landscape of the European Union’s (EU) pharmaceutical industry poses a significant challenge for companies aiming to remain compliant while ensuring the highest standards of product quality and safety. 

The stringent regulatory framework for EU pharma, designed to safeguard public health, mandates adherence to rigorous regulatory compliance with the European Medicines Agency (EMA),  Heads of Medicines Agencies (HMAs), the European Commission, and guidelines such as the Good Manufacturing Practice (GMP), and the Good Clinical Practice (GCP), among other requirements. 

By exploring the pivotal role of technology in enhancing compliance, and highlighting the importance of quality control systems like automated proofreading technology, this guide serves as a roadmap for pharmaceutical companies striving to navigate the demanding regulatory environment of the EU. 

Understanding EU Pharmaceutical Regulatory Compliance

The foundation of staying compliant begins with a thorough understanding of the relevant regulations in the European Union. 

The EU has established a comprehensive regulatory compliance framework that includes directives and regulations from the above-mentioned health authorities, along with specific national regulations of member states.

All of these guidelines are in place to ensure the safety, efficacy, and quality of pharmaceutical products, subsequently ensuring their proper use and the well-being of consumers and patients. These guidelines cover a broad spectrum, from clinical trials to marketing authorizations, pharmacovigilance, and manufacturing practices. 

Key EU Pharmaceutical Guidelines

Key pharmaceutical guidelines for the EU are enforced by the European Medicines Agency (EMA) and national regulatory agencies within member states, aiming to harmonize regulatory compliance standards across the EU and ensure the highest level of protection for public health.

Some key guidelines include: 

  • Good Manufacturing Practice (GMP): Any manufacturer of medicine intended for the EU market, regardless of its global location, must adhere to GMP standards, ensuring that the medicines are of consistently high quality, appropriate for their intended use, and meet the requirements of the marketing authorisation or clinical trial authorisation.
  • Good Clinical Practice (GCP): Represents an ethical and scientific quality benchmark for the design, recording, and reporting of trials involving human subjects, ensuring public confidence by protecting the rights, safety, and wellbeing of participants and guaranteeing the credibility of clinical trial data.
  • Good Laboratory Practice (GLP): Defines a set of rules and criteria for a quality system focused on the organizational process and conditions under which non-clinical health and environmental safety studies are systematically planned, executed, monitored, documented, reported, and archived.
  • Good Distribution Practice (GDP): Ensures that medicines are legally authorized, correctly stored and transported, free from contamination, properly rotated in storage, and delivered on time to the right recipient. It also mandates a tracing system for identifying and recalling faulty products. Additionally, GDP covers the proper handling of active ingredients and other materials used in making medicines.
  • Clinical Trials Regulation (EU) 536/2014: Aims to unify clinical trial rules across the EU by introducing a single submission and authorization process through an EU portal, a uniform assessment leading to one decision, and clear rules on participant protection, informed consent, and transparency.
  • Pharmacovigilance Legislation: Enacted in July 2012, this legislation mandates reporting and monitoring of adverse effects from medical products to ensure patient safety. It also establishes regulatory frameworks for assessing risks, managing safety information, and communicating it to healthcare professionals and the public.
  • Advanced Therapy Medicinal Products (ATMPs): ATMPs are divided into three main categories:
    • Gene therapy medicines: includes genes that cause therapeutic, preventive, or diagnostic effects by introducing lab-created DNA into the body to treat diseases like genetic disorders, cancer, or chronic illnesses.
    • Somatic-cell therapy medicines: consist of cells or tissues that have been altered in their biological characteristics or are used in different ways from their original functions in the body, aiming to treat, diagnose, or prevent diseases.
    • Tissue-engineered medicines: involve cells or tissues modified to repair, regenerate, or replace human tissue.

Leveraging Technology for Regulatory Compliance

Having gone through key pharmaceutical regulations in the European Union, let’s explore how technology helps organizations adhere to them to ensure the regulatory compliance of their products. To do this, technology plays a critical role in achieving and maintaining compliance, especially in regulated industries such as pharmaceuticals. 

Automated systems and advanced technologies such as Artificial Intelligence (AI) and Machine Learning (ML) are being leveraged to streamline regulatory compliance processes throughout the pharmaceutical and drug development lifecycle. These algorithms analyze vast amounts of data to identify patterns, deviations, and potential risks in manufacturing processes, enabling proactive intervention to prevent compliance breaches. 

For perspective, GlobalVision’s independent market research has recently shown that AI-powered technologies help pharmaceutical companies get their products to market faster. Our survey results revealed that 89% of regulatory survey respondents said that using AI-powered solutions significantly reduced their compliance review process, allowing them to deliver products to market faster.

This goes hand in hand with recent plans being put into place with regards to the use of AI in EU pharma. As it is predicted to be so substantial in the near future, the EMA and the HMA have published an artificial intelligence work plan to 2028, setting out a collaborative and coordinated strategy to maximize the benefits of AI to stakeholders while managing the risks.

Along with AI technologies, other solutions to consider are quality control systems that help organizations stay compliant by easing the regulatory compliance process, and improving processes, and also cloud-based solutions that enable data sharing among stakeholders to maintain data integrity and confidentiality. 

It is also important to take into consideration solutions that have gone through a validation process. Validation involves a series of activities that take place over the lifecycle of any product and process to ensure that it has the required quality and is satisfying all requirements before being used. 

By integrating these technologies into regulatory compliance frameworks, and taking into consideration certain features, EU pharmaceutical companies can enhance regulatory compliance, minimize risks, and ultimately improve the quality of their products.

The Right Solution for Regulatory Compliance – Automated Proofreading Software

Choosing the right technological solution is essential for ensuring compliance with EU regulations. But one that incorporates many solutions and leverages many technologies may be the best way to go. This is where automated proofreading software comes into play. 

Automated proofreading is an innovative quality control solution for pharmaceuticals that helps  maintain the accuracy and quality of documents and subsequent products by inspecting all types of regulatory content present in pharmaceuticals. 

These documents include, packaging inserts and leaflets, product labels and packaging, regulatory submissions, clinical trial protocols and reports, Standard Operating Procedures (SOPs), and marketing materials such as brochures, websites, and promotional videos.

Regardless of the type of file or document, the advanced system helps pharmaceutical companies in the EU uphold quality standards with greater ease and efficiency, ensuring regulatory compliance within the EU.

This technological innovation provides better proofreading results and empowers teams to produce compliant and error-free documents as it acts as an added layer of insurance in quality control processes. Some benefits of automated proofreading include:

  • Proofreads critical content at scale: Automates proofreading of large volumes of documents at lightning speed, saves valuable time and resources and accelerates company growth while maintaining quality assurance.
  • Mitigates risk of financial losses: Automatically identifies critical errors such as incorrect drug names, dosages, and safety warnings and minimizes the risk of costly errors like product recalls, legal disputes, regulatory fines, reputational damage.
  • Expedite time-to-market: Increases speed of review and approval cycles for regulatory submissions, labeling, packaging, marketing materials and more and allows organizations to gain a competitive market advantage.

In essence, automated proofreading works by comprehensively inspecting documents to find discrepancies in the file. The innovative software conducts detailed inspections and proofreads all packaging assets from text, color, graphics, barcodes, braille, and more. 

Through automated proofreading, inspections of packaging components are completed exponentially faster than traditional proofreading, and a task that once took hours or days to complete is now reduced to only a few minutes.

“The biggest benefit [of GlobalVision] to our facility is the reduction in the amount of processing and testing time (by at least a factor of 3) and the ability to receive competent and timely support when needed….Overall, the greatest benefit is being able to rely on a high-quality product that allows us to be more efficient.”

  • Veronica Guilliams, Senior Manager – Visual Inspection, Pfizer 

Why Automated Proofreading is Essential for EU Regulatory Compliance 

Automated proofreading software plays a crucial role in enhancing the quality and regulatory compliance of pharmaceutical products in the EU. Some reasons why automated proofreading is an essential tool and software to leverage are:

  • Error Detection: Swiftly identify potential errors on pharmaceutical files, guaranteeing both accuracy and quality. This is vital not only for regulatory adherence but also for safeguarding patient safety. Accurate content ensures vital product information such as ingredients, dosages, and expiry dates are correctly portrayed, mitigating potential risks and upholding user well-being.
  • Consistency: Verify consistency in terminology, dosage information, and instructions throughout pharmaceutical documentation. Consistent information reduces confusion among healthcare professionals and users, enhancing clarity and usability.
  • Regulatory Compliance: Adhering to stringent regulatory requirements is critical in the pharmaceutical industry. Automated proofreading ensures all content aligns with regulatory standards, minimizing the risk of non-compliance issues such as fines, recalls, or legal repercussions.
  • Efficiency and Speed: Streamlines the proofreading process compared to manual reviews and methods, offering significant efficiency gains. This speed offers a particular advantage in the dynamic and fast-paced pharmaceutical industry, where timely and accurate product releases are crucial to get oftentimes life-saving pharmaceuticals to market and to capture significant market share. 
  • Version Control: Facilitate effective version control, ensuring that all documents reflect the most current and accurate information. This mitigates risks associated with outdated content, maintaining precision and relevance.
  • Consistent Branding: For pharmaceutical companies with diverse product portfolios, maintaining consistent branding across all products and content is essential for brand recognition and trust. Automated proofreading aids in upholding this consistency, reinforcing brand integrity.

By leveraging automated proofreading, EU pharmaceutical companies can elevate the accuracy, quality, and regulatory compliance of their products. This ultimately not only enhances patient safety but also preserves the integrity of medical products, aligning with corporations commitment to excellence and safety in healthcare.

GlobalVision’s Verify For Complete EU Regulatory Compliance

Verify, is GlobalVision’s cloud-based proofreading platform that is tailored specifically for the needs of regulated industries in the European Union such as pharma. 

The software has been meticulously evaluated and its functionality, performance, security, and compliance with relevant standards and regulations in the EU is guaranteed as the software fits the needs of end-users and helps adhere to industry-specific regulatory compliance requirements.

As a solution created for regulatory professionals, teams, and corporations, Verify seamlessly integrates with existing workflows and acts as an added layer of insurance that mitigates the risk of errors slipping through in highly-regulated documentation. 

The software allows for comprehensive inspections with robust capabilities including text and graphics comparisons, spell check, braille, and barcode inspections, all critical components of EU pharmaceutical documentation. What’s more, these comprehensive inspections are done in record-time and eliminate the need for tedious, manual reviews.  

This speed and precision in document inspections allow for faster review and approval cycles, enabling EU-compliant products to reach the market quickly, subsequently capturing market share from competitors due to their expedited workflows and allowing for a competitive advantage. 

Conclusion

For the pharmaceutical industry, navigating the complex regulatory landscape of the European Union is no easy task and demands commitment to compliance. 

The strict regulations set forth by governing health authorities in the EU are in place to help ensure the safety and efficacy of medicinal products while subsequently ensuring the safety of the end user. 

Once a tedious and time-consuming task, adhering to regulations becomes easier when corporations turn to technology to help them adhere to regulatory compliance 

Leveraging technology not only increases the speed at which quality control processes can be undergone, but also increases the accuracy and efficiency. Automated proofreading in particular, stands out as an ideal technological solution for EU pharmaceutical companies, offering advantages to document reviews such as error detection, speed, consistency, and version control, to name a few.

By integrating this technology, companies can not only meet EU regulatory compliance requirements but also uphold the highest standards of product quality and safety, thereby reinforcing their commitment to excellence in healthcare and ensuring the well-being of consumers and patients alike.

If you want to begin ensuring the regulatory compliance of your EU pharma documentation, book a demo of Verify and see firsthand the transformative impact it will have on your pharmaceutical proofreading and quality control processes.

Also, read our Pharmaceutical Industry Report to get exclusive insights into the growing role of technology in regulatory affairs and see how other top industry leaders are leveraging this technology to help them achieve their business goals. 

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GVD Braille Height Sets A New Standard for Precision and Speed in Braille Inspections for EU Pharmaceutical Market

Date: April, 2024 | Category: Compliance | Author: Hana Trokic

GlobalVision’s Braille Height is breaking new ground by offering unmatched precision and speed never before seen for regulatory Braille inspections. With the new GVD Braille Height, inspections on pharmaceutical packaging can be completed in record time and with complete accuracy, getting products out to market faster than ever before.

This fully automated scanner-based solution is the first detailed Braille height measurement solution that measures the exact height of each individual Braille dot. Previously, teams had to rely on manual inspection methods or had to suffice with automated solutions giving an average measurement value across Braille regions instead of exact measurements, resulting in compromised compliance in the EU market.

GVD Braille Height not only eliminates the need for these error-prone and time-consuming manual Braille inspections, it also sets a new standard for speed of automated Braille inspections for professionals in regulated industries including pharmaceuticals and print and packaging. 

The GVD Braille Height inspection software is a one-of-a-kind solution on the market allowing teams in quality assurance and prepress to confidently meet regulatory standards and ensure accurate Braille assets leading to safer and more accessible products, marking a significant step forward in technology-driven quality assurance.

The Importance of Braille Accuracy 

In regulated industries, where adherence to standards and accessibility is crucial, Braille is a vital component of a product’s packaging or labeling to foster compliance and inclusivity.  

Braille, a universally accepted system of writing designed for individuals with visual impairments, is critical in ensuring that information, particularly in industries subject to strict regulations such as pharmaceuticals, is universally accessible.

The importance of Braille accuracy on pharmaceutical packaging and labeling cannot be overstated as it directly impacts the health and safety of consumers and patients with visual impairments. Taking into consideration that there are currently 295 million people worldwide with moderate to severe visual impairment, the need for Braille only becomes more pronounced.

 

 

In pharmaceuticals, where a single mistake can lead to serious health complications or even life-threatening consequences, the accuracy of Braille is a vital component of patient safety. Accurate Braille, including height, spacing, and translations, ensures that patients can independently access critical information regarding dosages, ingredients, and usage instructions, significantly reducing the risk of misuse. 

Yet, ensuring the accuracy of Braille assets is not just a matter of health safety, it is also a question of legal compliance and ethical responsibility. 

From a quality assurance and production perspective, Braille accuracy is vital as it is a mandatory component on pharmaceutical packaging all across Europe, governed by the European Medicines Agency (EMA) and is strongly recommended by the U.S. Food and Drug Administration (FDA) in Western markets, while other regions such as the ASEAN markets are working to heighten inclusivity by implementing Braille requirements on packaging soon.

Get To Market Faster Than Before 

By harnessing automated technology, the GVD Braille Height is 10X faster than competitor solutions and cuts down inspection times dramatically, from what would previously take several hours, down to just a few minutes. This drastic reduction in inspections enables teams to handle larger volumes of inspections with the same (or less) labor resources, boosting productivity and streamlining operations.

In the competitive EU medicines environment, time to market is a critical factor for success. The Braille Height inspection software streamlines inspection processes for Braille assets, allowing products to move more quickly from production to market. This speed can provide a competitive advantage, enabling companies to capture market share more effectively. It also aids teams specifically in pharma packaging to produce fast and accurate products allowing for life saving medicines and drugs to reach consumers more quickly.

In under 3 minutes, the software can accurately inspect Braille height for each individual dot, and all other aspects of Braille across various materials and formats, including foil cartons and full press sheets. It can also inspect and translate Braille in 43 languages – the highest amount of supported languages available for Braille translations – allowing for easier global scalability. 

These metrics once again set GVD Braille Height apart from other solutions as its automated technology is more robust and comprehensive than any other solutions on the market.   

For perspective, competitor software on average takes 50 mins to complete a full Press sheet Braille inspection, while GVD completes the same inspection in less than 3 minutes. What’s more, inspections can be done in 43 global languages, on different materials, across multiple Braille regions, and can be conducted simultaneously, with other GVD capabilities such as graphics, text, color, and barcode inspections. 

All of these capabilities allow teams to accelerate their inspection times and get vital pharmaceutical products to markets all across Europe at never before seen speeds. 

Experience Unmatched Braille Accuracy Through Precise Inspections

Traditionally, Braille inspections have been conducted manually to ensure the accuracy of Braille on packaging, labeling, and other regulatory documentation. This method involved trained personnel visually inspecting for obvious defects such as missing dots, misalignment, or inconsistencies in the Braille pattern. It also involved tactile inspections where Braille would be manually felt to ensure that the dots are raised to the correct height, are distinguishable to the touch, and are translated properly.

Due to the high risks that come with manual inspections, these methods have proven to be unreliable verification processes that are highly susceptible to human error, including oversight and fatigue. The GVD Braille Height mitigates these risks by automating the inspection process, thus significantly lowering the chances of mistakes that can compromise the quality and compliance of Braille outputs.

The Braille Height inspection software enables teams to check for Braille accuracy through automated inspections that check for Braille height, spacing, translations, missing dots, and more in one comprehensive scan. For Braille height specifically, the software inspects the exact height of each individual Braille dot ensuring the accuracy of Braille assets with extreme precision. 

In a matter of minutes, the inspection will yield a detailed report of all non-compliant Braille dots on packaging assets, allowing teams to make adjustments accordingly and ensure the complete accuracy of their regulatory documentation. 

Currently, GVD Braille Height is the most accurate on the market, yielding inspections that are 2 X more accurate than competitor solutions. 

Have Complete Confidence in Your Compliance 

For pharmaceutical and packaging industries, the accuracy of Braille on packaging and labeling is critical. This is due to the fact that errors in Braille can lead to devastating non-compliance issues.

When it comes to inspecting Braille accuracy on regulatory content such as packaging and labeling files, the process is done to ensure, amongst many things, the compliance with the Marburg Medium Font Standard as well as ISO 17351:2013 requirements for Braille on pharmaceutical products. 

Braille inspections in particular have posed challenges to the pharmaceutical and print and packaging industries as stringent regulations such as the Marburg Medium Font Standard requires a height of 0.20mm, with many companies producing at a height of 0.10mm. This makes Braille’s height incredibly difficult to measure through manual inspections and heightens the risk of errors slipping through that can lead to non-compliance issues.

GVD Braille Height addresses these unreliable and inefficient manual verification processes, reducing risks of incorrect Braille translations, tactile issues, spacing errors, and spelling mistakes, all of which cause compliance issues such as financial penalties, recalls, risk to consumer and patient safety and damage to a company’s reputation. 

This automated solution detects even minor discrepancies in Braille assets by inspecting each individual Braille dot, thereby increasing the accuracy and reliability of Braille asset verification. Not only does it render manual inspections obsolete, it outpaces other automated solutions that only give average measurement values across Braille regions.   

This advanced technology allows teams and organizations to avoid the consequences of non-compliance as they can now meet regulatory standards with greater precision, accuracy, and speed.

A New Standard for Braille Inspections

Due to its never-before seen accuracy, precision, and speed, the GVD Braille Height is a market-leading solution that sets a new standard for Braille inspections. 

Incoming quality assurance and production teams in the pharmaceutical and print and packaging industries can now leverage the latest and most innovative Braille inspection technology to eliminate bottlenecks and get critical products out to market all across the European Union faster than any other competitor.

By replacing slow, inefficient, error-prone manual inspections with fast, accurate, and automated technology, the Braille Height inspection software eliminates risks associated with human errors in Braille verification which include incorrect translations, tactile issues, spacing errors, and spelling mistakes all which can all lead to compliance issues, financial penalties, recalls, risks to consumer and patient safety, and damage to a company’s reputation.

If you want to discover the full capabilities of our innovative GVD Braille Height, book a demo today and see firsthand the transformative impact it will have on the accuracy, speed, and compliance of your regulated Braille assets.

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10 ChatGPT Prompts to Enhance Pharmaceutical Proofreading

Date: April, 2024 | Category: Proofreading | Author: Hana Trokic

With AI, pharmaceutical companies can now streamline the process of analyzing vast amounts of data and documentation, ensuring compliance with regulatory standards and minimizing errors. ChatGPT, for example, with its natural language processing capabilities, empowers regulatory and quality assurance teams in pharma to leverage AI in simple ways that greatly enhance the overall quality of their content revisions. 

It can serve as a valuable tool for reviewing and refining regulatory documents by providing real-time feedback and suggestions,enabling efficient analysis of complex regulatory requirements, and ensuring compliance with stringent standards. 

By leveraging AI solutions such as ChatGPT, pharmaceutical companies can streamline the documentation revision process, identify potential errors or inconsistencies, and refine language to convey information more clearly and accurately. This not only improves the quality of their documentation but also enhances overall efficiency, ultimately contributing to safer and more reliable healthcare products.

Below, we delve into various ChatGPT prompts that revision teams in the pharmaceutical industry can use to streamline their proofreading efforts, improve accuracy, and ultimately accelerate time to market for vital drugs and medications.

The Difference Between ChatGPT and GPT Pro for Pharmaceutical Proofreading 

Before using ChatGPT to help enhance your pharmaceutical proofreading, it is important to understand the differences between ChatGPT, the free version, and GPT Pro, a paid version of the AI tool.  

ChatGPT is proficient in understanding and generating human-like text, offering a solid foundation for proofreading tasks, identifying grammatical errors and suggesting stylistic improvements in documents. However, its use case in pharmaceuticals is somewhat limited due to its generality. 

GPT Pro builds on ChatGPT’s conversational features with enhanced precision, offers a deeper understanding of pharmaceutical terminology, and the ability to adhere to the stringent regulatory standards of the industry. GPT Pro’s advanced algorithms can navigate the complex language of pharmaceutical documentation such as clinical research papers, drug development reports, and regulatory submissions with a high level of accuracy. This not only improves the efficiency and reliability of proofreading processes but also significantly reduces the risk of costly errors. 

What’s more, with the pro version of ChatGPT, users will be able to upload images and documents, a feature that can really aid teams that work with long form documentation and ultimately offer better quality results to specific prompts. 

Finally, ChatGPTs knowledge base is more up-to-date, resulting in more accurate answers and results to prompts. ChatGPT was last updated in January 2022, while ChatGPT Pro was updated in April 2023. 

While the pharmaceutical proofreading needs of individual teams can vary, it is important to research and choose the best software for your needs to yield the best proofreading results of your critical content.

1. Simplifying Complex Information

Prompt: “Summarize the following document* for a non-specialist audience, highlighting key points and any areas that may require further clarification. Extract specific quotes.”

This prompt helps teams break down complex pharmaceutical documents into simpler summaries, making it easier to identify areas that may be prone to misinterpretation or errors. By focusing on clarity and comprehension, teams can ensure that essential information is accessible to all stakeholders, including regulatory bodies and patients, and also ensure their pharmaceutical proofreading has been heightened. 

*Note: You will need access to GPT Pro to upload documents 

2. Identify Regulatory Guidelines

Prompt: “Review this file and identify the regulatory guidelines that apply to the document, highlighting the sections.”

With regulations constantly changing and evolving, keeping up with all updates can be difficult and time-consuming. This prompt directs ChatGPT to scan documents for compliance by indicating which specific regulatory guidelines are present in the file. By identifying the guidelines, it will be easier to conduct manual checks of said guidelines to confirm if they are up-to-date, ultimately safeguarding from potential issues that may require attention. It’s a proactive step in mitigating risks associated with regulatory submissions and ultimately improving your pharmaceutical proofreading.

*Note: You will need access to GPT Pro to upload documents 

3. Enhancing Document Consistency

Prompt: “Check this document for consistency in terminology, and referencing against the provided style guide.”

Consistency in pharmaceutical documentation ensures clarity and professionalism, reducing the risk of consumer and medical staff misinterpretation. This prompt assists teams in maintaining uniformity throughout a given document such as labeling files or instructions for use  improving the overall pharmaceutical proofreading process and subsequently the wuality of pharmaceutical products. 

4. Detailing of Storage and Handling Instructions

Prompt: “Review storage and handling instructions for detail and clarity, ensuring they are practical and can be easily followed by end-users.”

This prompt helps ensure that instructions for storing and handling medications are clear and easy to follow, which is key to preventing mistakes and ensuring the medicine works as it should. From doctors to patients, it ensures that everyone understands how a pharmaceutical product should be stored and used safely and effectively.

5. Verifying Scientific Data and References

Prompt: “Verify the accuracy of the scientific data and references in this document, flagging any discrepancies or outdated information.”

Accuracy in data and references is non-negotiable in the pharmaceutical industry and regulated industries in general. For pharmaceutical proofreading, this prompt can help teams ensure that all cited studies and data points are current, relevant, and correctly interpreted, increasing the document’s credibility.

6. Ensuring Clear Communication of Risks and Side Effects

Prompt: “Highlight any sections related to drug risks and side effects that may need clearer explanation or more prominent disclosure.”

Effective communication of risks and side effects is crucial in pharmaceuticals for patient safety. This prompt for pharmaceutical proofreading aims to ensure that information on documentation such as drug packaging inserts, patient information leaflets (PILs), and medication guides is presented clearly and prominently, facilitating informed decision-making by healthcare providers and patients alike.

7. Cross-Checking Dosage Instructions

Prompt: “Review the dosage instructions in this document for accuracy and clarity, ensuring they are concise and easily understandable by healthcare professionals.”

This prompt focuses on the critical aspect of medication dosage, aiming to ensure that instructions on documents such as prescribing information, summary of product characteristics (SPC), patient information leaflets (PILs), and emergency use authorizations (EUA) are both accurate and clearly understandable to those administering the drugs.

8. Identifying Potential Ethical Concerns

Prompt: “Scan this document for any potential ethical concerns related to patient privacy, informed consent, or the presentation of clinical trial results.”

Ethical considerations are paramount in pharmaceutical documentation. This prompt helps in pharmaceutical proofreading by proactively identifying sections that might raise ethical issues, ensuring respect for patient rights and integrity in reporting.

9. Enhancing Document Accessibility

Prompt: “Suggest changes to improve the accessibility of this document, including the use of non-technical language, visual aids, and structure for readers with varied abilities.”

Accessibility ensures that information is available to everyone, regardless of their technical background or physical abilities. This prompt for pharmaceutical proofreading encourages the creation of documents that are more inclusive and user-friendly.

10. Optimize for Searchability

Prompt: “Review the document’s layout to improve searchability, including the use of headings, bullet points, and keywords related to the drug’s use and effects.”

Being able to find critical information about a pharmaceutical product quickly is of high importance. This prompt for pharmaceutical proofreading improves document organization, making important drug information like dosages and side effects easier to find and understand quickly. It helps consumers quickly locate the information they need, ensuring safety and efficiency in drug use.

Simple ChatGPT Prompts for Pharmaceutical Proofreading 

Simple ChatGPT prompts also offer immense value to revision teams in the pharmaceutical and other regulated industries. They are quick ways to ensure certain aspects of documentation are accurate, compliant, and are overall error-free, consistent and ready for market. 

The following short and simple ChatGPT prompts can help heighten pharmaceutical proofreading:

  • Is there any misleading information in this document?
  • Review this section of our regulatory submission and provide suggestions for improving clarity and compliance.
  • Help us identify any potential inconsistencies or errors in this document.
  • Is there any inconsistent language in this document? 
  • Summarize the key regulatory requirements for this product and provide a concise overview. 
  • Generate a comprehensive list of references to support the efficacy and safety claims in our submission.
  • We need to optimize the labeling information for this drug. Can you assist with drafting clear and compliant language?
  • Review our clinical trial data and ensure that it aligns with regulatory guidelines and standards.
  • Interpret the latest regulatory updates and incorporate them into our submission. 
  • Suggest ways to strengthen the risk management section of our regulatory documentation.

By leveraging AI, even in simple ways like using these simple ChatGPT prompts above, pharmaceutical companies can expect to see vast improvements in their proofreading processes while having an added layer of assurance that their documentation is free from errors and aligns with all regulatory and compliance requirements. 

Automated Proofreading for Pharma – A Leading Technological Solution 

While ChatGPT is a great tool to use to ensure certain aspects of your documentation is accurate, automated proofreading software is a comprehensive solution that leverages AI technologies to ensure the complete and holistic integrity of critical pharmaceutical and regulatory documentation and is an ideal solution for pharmaceutical proofreading. 

Any revision team in pharmaceuticals that deals with extremely sensitive documentation and products where even a minor content error can have detrimental or irreversible consequences can benefit from automated proofreading software.

Much in the same way ChatGPT identifies issues quickly, Verify, conducts comprehensive inspections of regulatory documents in a matter of minutes and produces an annotated report of all differences found, allowing for teams to make appropriate adjustments in record time and ensuring the accuracy, compliance and quality of documents and critical assets. 

The software’s diverse capabilities enable teams to effortlessly run a holistic inspection of documents to detect errors, from text, spelling, graphics, barcode, and braille.

This provides teams in the pharmaceutical industry with an added layer of insurance and a sense of confidence, knowing that all errors are being identified, and amended and that only high-quality products are going out to market.  

Conclusion

The integration of AI-powered tools like ChatGPT into the regulatory documentation process and for pharmaceutical proofreading represents a significant shift in the way revision teams tackle their proofreading and revision tasks in pharmaceuticals and other regulated industries. 

From simplifying complex information, ensuring regulatory compliance, enhancing document consistency, and improving overall clarity and accuracy, these AI solutions are paving the way for new benchmarks in accuracy, efficiency and reliability in healthcare product development and beyond. 

As these AI technologies continue to develop and AI applications continue to be refined, proofreading tasks will become increasingly easier and faster leading to safer, more accessible healthcare products. 

If you’re ready to take the first steps towards leveraging AI technologies to produce error-free regulatory content, get started with Verify’s automated proofreading software specifically tailored to regulated industries, and begin experiencing the advantages of using cutting-edge technology to proofread your critical content. 

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Verify’s New AI-Powered OCR Feature Brings Unmatched Character-for-Character Inspections to Regulated Industries

Date: February, 2024 | Category: Company | Author: Hana Trokic

Verify’s New AI-Powered OCR Feature is Here!

Verify, GlobalVision’s newest and most innovative cloud-based proofreading software, has just raised the bar for proofreading in regulated industries with the official launch of its groundbreaking AI-powered OCR (optical character recognition) feature. 

This launch is set to transform the compliance and proofreading landscape, bringing with it many benefits that cater to the diverse needs of regulated industries ranging from regulatory, commercial pharma, to agencies, labeling and more.  

The addition of OCR to the Verify platform marks a strategic launch into Artificial Intelligence, aligning with GlobalVision’s commitment to empowering regulated industries with cutting-edge solutions that facilitate their workflows and accelerate time-to-market.

Watch our OCR feature in action! 

The OCR Technology Gap 

Previously, without OCR proofreading technology, regulatory, commercial, and labeling professionals in regulated industries, as well as the agencies that serve them, struggled with manual processes, facing challenges in handling flattened documents containing rasterized text. They were forced to perform visual text extractions, manual proofreading, and manual data entries.

While receiving flattened documents is often out of their control due to the many stakeholders often involved in working on a single document, in the absence of OCR technology, having to perform manual proofreading hinders efficiency, exposes them to potential errors and compliance risks, compromises consumer and patient safety, and causes bottlenecks in the asset development process. 

These critical problems only worsen with the added challenge of localization and translation tasks necessary for scalable, multinational operations.

Verify’s AI-Powered optical character recognition technology is designed to solve these problems and revolutionize how regulatory, commercial, agencies, and labeling teams handle text within their document review processes, bringing automation and accuracy to the forefront. 

OCR for Compliance With Regulatory Requirements

For industries governed by strict regulations, compliance is non-negotiable. 

Regulatory teams are often faced with the difficulty of dealing with rasterized documents, leading to manual inspections, increased risk of errors, and workflow inefficiencies. Similarly, commercial teams and agencies encounter difficulties in handling vast amounts of promotional content which is held to the highest standard in compliance, hindering creativity and time spent on more meaningful work. In parallel, labeling teams also deal with proofreading tasks within strict deadlines and regulations. 

With the launch of Verify’s newest AI-powered OCR feature, compliance and review processes are simplified through the automation of text extractions, and the verification of critical text data in documents. This not only eliminates the need for error-prone manual checks, it ensures greater accuracy and significantly reduces the risk of human error, ultimately streamlining compliance processes and ensuring compliance with global health authorities. 

Regulated companies can now navigate the complex regulatory landscape with greater confidence, knowing that Verify’s OCR feature acts as an added layer of insurance, guaranteeing the quality of their documentation. 

Increased Patient and Consumer Safety Assurance

Verify’s OCR feature will help ensure the accuracy of critical content that is directly associated with patient and consumer safety. This spans a wide range of content types that could potentially hinder safety such as instructions for use, allergen statements, dosages, warning statements and more. 

If documents or digital packaging assets do not contain live text, the absence of OCR technology would force content revision tasks to be done manually. With files or labels that include small text, graphics of text, and multilingual files in different languages and scripts, this could prove to be a time-consuming and almost impossible task. 

By automating the extraction of rasterized text, OCR not only accelerates the proofreading process it also provides a level of accuracy for document and label inspections that was not previously possible, as it allows for a character-for-character precision level

Thanks to this technology, pharmaceuticals, medical device, and CPG companies can ensure that their customers remain safe thanks to the mitigation of potential errors slipping by. 

Accelerated Scaling of Global Operations

Scaling globally often comes with the challenge of dealing with multiple languages, different scripts and the obligation of adhering to global regulatory standards—noting that the complexity is compounded when those tasked with proofreading are not native to the languages they are faced with. 

Verify’s OCR feature facilitates the extraction of text for translation purposes which supports the localization of documents. This reduces the risk of errors in translated content, whether it be regulatory, promotional documents, or labels. 

This allows brands to scale globally at a quicker rate by efficiently and safely distributing error-free products and content across their target markets.

With Verify’s new AI-powered OCR feature, the software has the ability to proofread and validate content in various languages and scripts even if they are in a flattened format, enhancing efficiency and promoting consistency in communication, facilitating smoother global expansion strategies.

Faster Product Time-to-Market

For regulated industries, being first to market offers a huge competitive advantage with often limited market share to capture before it’s too late. Thankfully,  Verify’s new OCR feature leverages AI technology to expedite the proofreading process, reducing the overall time it takes to bring products to market. 

For teams who deal with proofreading regulatory submissions, batch records, promotional and marketing materials, as well as labels or packaging assets, optical character recognition will prove to be particularly beneficial.  

By automating text extractions and reducing the need for manual content revisions and manual data entries, content revisions are now sped up throughout the product development lifecycle, allowing companies to respond more swiftly to market demands and gain a competitive edge.

This feature will also specifically benefit label labeling teams as the content they review includes both physical label scans as well as e-labels. In these cases, labeling teams are often forced to manually review and proofread within strict deadlines—increasing the risk of errors, and often delaying product time to market for sometimes life-saving drugs and medical devices.

With Verify’s new OCR feature, these teams will not only accelerate their speed to market, they will also have complete confidence that their documents and labels are accurate when they hit the market. 

Protect Your Brand’s Reputation

Verify’s OCR feature acts as a safeguard against damaging content errors, which can lead to catastrophic consequences on a brand’s image. 

By maintaining the integrity and accuracy of content, the software protects brand reputation and instills confidence among customers, stakeholders, and the wider public. It reduces the risk of typographical errors that could impact brand perception and contributes to a cohesive and reputable brand image. 

OCR allows regulatory, commercial, labeling professionals in regulated industries, and agencies to achieve streamlined workflows, and elevated brand excellence. With this feature, they can deliver accurate, compliant, and impactful content and packaging assets to market, contributing to the overall consistency and success of their brand. 

Begin Your AI Journey with New AI-Powered OCR! 

The official launch of Verify’s AI-Powered OCR feature signifies a transformative moment for proofreading in regulated industries. 

This feature brings innovation to the technology gap that was previously stunted by manual processes, providing a solution that significantly reduces the risk of errors and ensures compliance in industries that need to adhere to strict regulations. 

Verify’s new OCR launch also goes beyond the needs of regulated industries and actively contributes to increased patient and consumer safety assurance, accelerated global operations, faster time-to-market, and the protection of brand reputation. 

This innovative feature leverages the latest AI technology to reinforce Verify as a market-leading proofreading solution for regulated industries, empowering professionals with cutting-edge solutions and setting a new standard for excellence in compliance and proofreading workflows.

If you want to experience these benefits and more, begin your AI journey and try Verify’s OCR feature for free today. 

If you want to discover the full capabilities of our innovative cloud-based proofreading software, book a demo of Verify and see firsthand the transformative impact it will have on your proofreading and quality control processes.

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Why Regulatory Affairs Teams Need Document Comparison Software in 2024

Date: February, 2024 | Category: Proofreading | Author: Hana Trokic

Why do regulatory affairs teams need document comparison software in 2024?

For Regulatory Affairs, where adherence to strict compliance standards and efficient quality control processes are critical, the use of technology to help ease daily workflows has become particularly apparent in the past decade—2024 is expected to be no different.  

While Regulatory Affairs teams are faced with growing complexities due to large content workflows, ever-changing regulations, and faster-than-ever product-to-market times, they continuously turn to technology to address bottlenecks in their proofreading and compliance review processes.  

One tool that has been proven vital for the content reviews of Regulatory Affairs professionals is document comparison software which helps proofread critical content at scale, mitigate risks of financial losses, and expedite product time to market.

What is Document Comparison Software 

Document comparison software allows users to compare two and identify their differences within seconds. 

The software is designed to help users detect changes made to files as they move through revision and submission cycles, correcting errors, ensuring consistency, and overall simplifying proofreading processes while increasing accuracy and efficiency. 

Document comparison software inspects digital files, including labels and packaging materials, to find any discrepancies between the two. A simple inspection will reveal and pinpoint differences allowing adjustments and corrections to be made in record time. 

This technology plays a crucial role in regulated industries such as pharmaceuticals, and consumer packaged goods where precise and accurate documentation is essential from reviewing initial drafts to final submission documentation. 

Automated Quality Control 

Document comparison software simultaneously serves as an automated quality control tool that expedites the proofreading process and enhances the accuracy of your work.

This type of software automates the revision process through digital inspections that can detect errors across files and documents at all stages of the content lifecycle – even in the early stages. By catching errors early on, it helps to avoid the need for multiple inspections, saving time and resources for Regulatory Affairs teams. 

Additionally, the software also contributes to the overall efficiency and saves resources for cross-functional teams. The streamlined process ensures that all teams involved can allocate their time and resources more effectively, creating a more coordinated and time-efficient work environment.

With document comparison software you can find discrepancies in text, spelling, images, graphics, barcode, color, and braille, making it ideal for Regulatory Affairs teams that deal with documentation that needs to adhere to strict regulations in all of these areas. 

It also allows for the automatic inspections of digital files commonly reviewed by regulatory teams. This includes regulatory submissions, instructions for use, drug development documents, legal agreements, and much more. 

With document comparison software, you can increase your confidence in regulatory submissions and subsequent product launches by ensuring that all documentation, labeling, and packaging go out to market without any errors.

Why is Document Comparison Software Important for Regulatory Affairs Teams in 2024

Document comparison software plays a critical role in Regulatory Affairs for several reasons, addressing this field’s unique challenges and requirements. 

The software allows teams to increase the efficiency of their workflows by speeding up compliance review and proofreading processes, identifying errors, and ensuring the overall integrity and quality of their regulated documents. 

The main reasons why document comparison software is important for Regulatory Affairs include: 

  • Ensures Regulatory Compliance: Regulatory affairs navigate a complex landscape of evolving standards, regulations, and guidelines. They are tasked with reviewing critical content such as regulatory submissions, labeling & packaging files, clinical study protocols, marketing and promotional materials, and more. Document comparison software plays a vital role in ensuring the regulatory compliance of these files by thoroughly comparing document versions and highlighting all differences to ensure that only the intended changes were made while no unintended changes were introduced.
  • Saves Time and Enhances Productivity: Manual comparisons of lengthy regulatory documents is a time-consuming task. Document comparison software automates this process, significantly reducing the time and effort required for proofreading. This efficiency not only saves time but also enhances overall team productivity, allowing regulatory affairs professionals to focus on more strategic aspects of their work.
  • Reduces Risk of Errors and Oversights: Inaccuracies or oversights in regulatory documentation can have severe consequences. This risk is only heightened when conducting manual checks. Document comparison software minimizes the risk of errors by providing a detailed and accurate overview of differences and deviations on a file. This helps teams catch discrepancies early in the process, mitigating the potential for regulatory issues, product recalls, or legal actions due to documentation errors, and ultimately facilitates and ensures compliance with health authorities. 
  • Ensures Patient and Consumer Safety: Document comparison software helps Regulatory Affairs teams keep track of changes in regulations, ensuring accurate and up-to-date information. It fosters better collaboration among diverse regulatory teams, simplifying the revision process. This ultimately leads to the software playing a key role in protecting consumers and patient safety by ensuring the accuracy of crucial information in documents such as instructions for use (IFUs), labels, allergen statements, dosages, and warning statements, to name a few. 

How to Implement Document Comparison Software

Yes, regulatory affairs teams need document comparison software in 2024, but how easy it is to implement? 

The ability to efficiently review critical documentation in Regulatory Affairs is essential for maintaining the accuracy of documentation and compliance. That is why document comparison software has become a valuable tool for organizations looking to enhance their document management processes in 2024 and beyond. 

Here are simple steps you can follow to implement this innovative technology into your content revision workflows in 2024: 

  • Define Your Requirements: Before searching for the perfect document comparison software for your team, clearly outline your organization’s requirements. Consider the types of documents you frequently work with, the level of detail needed in inspections, and the frequency of your document revisions. Understanding these aspects will guide you in choosing the most suitable software for your needs.
  • Select the Right Software: Next, it’s time to search the market and sift through potential solutions. When making a final decision, consider the features, ease of use, data security, support, and compatibility with your existing systems to make an informed decision. All of this will help you choose the document comparison software solution that aligns best with your identified requirements.
  • Integrate with Your Workflow: Once you’ve selected a software solution, ensure seamless integration with your existing workflow. Collaborate with your IT and implementation teams to address potential compatibility issues and ensure a smooth transition. Consider how the software will interact with your document management system to optimize efficiency.
  • Schedule User Training: Once the software has been implemented, provide comprehensive training for teams to familiarize them with the software’s features and functionalities. This step is crucial to ensure that your team can effectively navigate and utilize the full potential of the document comparison software.
  • Don’t Forget About Regular Software Updates: Document comparison software evolves over time with updates and improvements. Regularly check for updates and implement them promptly to access new features, enhance performance, and ensure compatibility with the latest document standards and compliance regulations. Alternatively, opt for a solution that offers automatic updates every quarter and prioritizes innovation, ensuring you consistently benefit from the latest advancements in technology.
  • Establish Guidelines and Best Practices: To maintain the efficiency and accuracy of your content revision workflows, establish clear guidelines and best practices for the use of the software. Define standard procedures and regularly review and refine these guidelines based on user feedback and evolving document requirements. For pharmaceutical and CPG companies, it’s crucial to go beyond general guidelines and establish specific Standard Operating Procedures (SOPs) for using document comparison software. This ensures a more organized and compliant approach that meets the unique regulatory requirements of these industries.
  • Conduct Ongoing Review and Optimization: Implementing document comparison software is not a one-time task. Conduct regular audits of your content revision and proofreading processes and see where teams need support or added training. See what technological gaps you may have and amend them to keep your workflows optimized. Update training materials, and refine guidelines to continuously enhance the efficiency and effectiveness of your proofreading practices.

Automated Proofreading – A Leading Technological Solution 

GlobalVision is the market-leading document comparison software and automated proofreading tool for Regulated Industries, specifically built with their requirements in mind. 

For over three decades, this technology has proven to be beneficial for Regulatory Affairs teams. This successful track record with some of the world’s largest companies in the regulated industry is only expected to grow in the future, making 2024 the perfect year to start incorporating this transformative technology into your content revision workflows. 

Any regulatory affairs team that deals with extremely sensitive documentation and products where even a minor content error can have detrimental or irreversible consequences can benefit from document comparison software.

The software’s diverse capabilities enable regulatory affairs teams to effortlessly maintain compliance of documentation across the asset lifecycle. Holistic inspections of documents enable the software to detect all errors, allowing for teams to make appropriate adjustments, ensuring the accuracy and quality of documents and critical assets. 

This provides companies with an added layer of insurance and a sense of confidence, knowing that all errors are being identified, and amended and that only high-quality products are going out to market.  

Conclusion – Why Regulatory Affairs Teams Need Document Comparison Software in 2024?

Regulatory Affairs need to make the best of technology available to them to ensure that they implement and use best practices in their workflows. This way, they will be able to optimize processes and stay profitable while thriving in the very competitive and fast-paced globalized markets in 2024. 

As Regulatory Affairs teams continue to learn how to navigate the difficulties of ever-changing compliance regulations and look for ways to ease their proofreading processes, the adoption of document comparison software stands out as the ideal technological solution of the year.

If you’re ready to take the first steps towards error-free content in 2024, get started with GlobalVision’s document comparison software and begin experiencing the advantages of our cutting-edge technology today while seeing firsthand why regulatory affairs teams need document comparison software in 2024!

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Medicine Packaging: Navigating Regulations in the UK

Date: January, 2024 | Category: Compliance | Author: Hana Trokic

In the UK healthcare industry, medicine packaging plays a crucial role in ensuring the efficacy and security of not only medical products but of consumers as well. 

Over the years, requirements of UK medicine packaging have undergone significant changes, driven by advancements in technology, changes in consumer expectations and needs, and, most importantly, the ever-evolving stringent regulations imposed by regulatory agencies such as the MHRA.

Understanding and navigating these regulations is essential for medical companies to bring their products to market quickly and securely, and for healthcare professionals to ensure patient safety when prescribing medicine. 

The Early Days of UK Medicine Packaging 

Throughout history, the main role of UK medicine packaging has been to safeguard and conserve the contents of medical products. Glass bottles and vials were commonly used and were typically sealed with cork stoppers. 

These bottles were usually accompanied by simple labels containing essential information. The labels were essentially handwritten instructions and information on paper that would be wrapped around the bottle. Overall, packaging was basic, serving the primary purpose of protecting the medication from external contaminants.

However, as the medical industry advanced, so did the need for standardized and regulated packaging to ensure patient safety and facilitate the administration of medications.

Blister Packs and Pill Bottles

As medicine research advanced, so did the need for more sophisticated packaging. In the mid-20th century, blister packs, the ones we so often see today, emerged as a popular choice. This sealed, foil-based packaging, offered enhanced protection against moisture and air and helped in extending the shelf life of medications. 

Glass bottles were becoming less common as plastic pill bottles became a more popular substitute. They provided a more user-friendly and portable alternative to the old, heavy, and fragile glass bottle.  

The Rise of Regulation in UK Medicine Packaging

While advancements in UK medicine packaging were present throughout the 20th century, the greatest turning point came with the strict implementation of medicine regulations aimed at standardizing the industry. This was due to the fact that traditional UK medicine packaging and the lack of proper guidance and regulation were proving to be greatly limited in ensuring the safety of products and consumers.

Regulatory agencies have been present globally since the beginning of the 20th century, but in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has been at the forefront of setting guidelines to ensure the quality, safety, and efficacy of medical products since 2003. 

Their main responsibilities include:

  • Ensure safe and effective medicines, medical devices, and blood components
  • Establish a secure supply chain for healthcare products
  • Promote global standardization for the safety and effectiveness of biological medicines
  • Educate the public and healthcare professionals on the risks and benefits of healthcare products for safer use
  • Support innovation and research for public health benefits
  • Collaborate with UK and international partners for early access to safe healthcare products and to safeguard public health

Since its implementation, the United Kingdom has played a pivotal role in shaping the evolution of UK medicine packaging through its stringent regulatory framework. The MHRA consistently sets forth updated guidelines that govern the packaging of medicine, ensuring safety, efficacy, and adherence to quality standards. 

Labeling Requirements of UK Medicine Packaging 

UK medicine packaging is made up of many different components that are all strictly regulated and controlled to ensure its accuracy and safety for use and consumption. 

One of the most critical aspects of UK medicine packaging is the labeling, or the information provided on labels. Regulations mandate that packaging must include essential details such as the name of the medicine, dosage instructions, expiry date, batch number, and manufacturer information, to name a few. 

Additionally, UK medicine packaging labels often feature critical safety information, such as potential side effects and storage guidelines. The main goal of a label is to ensure that individuals administering or consuming the medication are well-informed about its proper use and potential risks. 

Compliance with labeling regulations not only supports the safe and effective use of medicines but also plays a pivotal role in promoting transparency and accountability within the medical industry. Strict adherence to labeling requirements contributes to the overall goal of ensuring public health by providing users with all the necessary information and knowledge needed to make informed decisions about their healthcare.

Tamper-Evident Measures

Tamper-evident packaging is described as “having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred.” 

These measures in UK medicine packaging play a crucial role in ensuring the safety and integrity of medical products. The measures are implemented to provide visible signs of interference, making it evident if a package has been tampered with or compromised. 

Common tamper-evident features include seals or bands that are broken or altered when the packaging has been opened. By incorporating these features and measures, UK medicine packaging manufacturers aim to protect consumers from potential tampering, contamination, or unauthorized access to medications. 

Tamper-evident packaging not only serves as an added layer of protection and security but it also builds trust among patients and healthcare professionals, assuring them of the authenticity and safety of the medicine inside a package. This added security measure contributes significantly to maintaining the quality and reliability of medicine products throughout the supply chain, ultimately safeguarding public health. 

Child-Resistant Packaging

Another important addition to UK medicine packaging regulations came in the later half of the 20th century. Child-resistant packaging became a requirement, addressing concerns about accidental ingestions and poisoning of young children. This type of packaging is designed to be difficult for children under the age of five to open, thus reducing the likelihood of unintentional ingestion.

Child-resistant UK medicine packaging was first introduced into the United Kingdom in the mid 1970s but only became standardized in 2001. Since then, a number of different regulations have been put in place, including European and International standards, as well as the Human Medicines Regulations 2012 and GHS/CLP, which became fully effective in 2015.

Since its introduction, child-resistant packaging has undergone many changes, not only in increasing resistance to potentially being opened by children but also in optimizing usability for adults. There have been continuous efforts to increase the safety of these products and their packaging with constant new developments in packaging improvements. 

Barcoding and Serialization 

Barcoding and serialization are integral components of modern UK medicine packaging, designed to enhance traceability, authenticity, and overall supply chain security. 

Barcoding involves the assignment of unique identifiers, typically in the form of barcodes, to individual medicine packages. This unique identification enables efficient inventory management, reduces errors in product distribution, and facilitates rapid tracking throughout the supply chain. 

Serialization takes this a step further by assigning a distinct serial number to each medicine unit, allowing for precise tracing of products from manufacturing to distribution to the end-user. These measures not only contribute to streamlined logistics but also play a pivotal role in combating counterfeit medicine and in ensuring patient safety. 

GMP (Good Manufacturing Practices) 

Good Manufacturing Practices (GMP) in UK medicine packaging represent a set of strict quality standards and guidelines that medicine manufacturers must adhere to in the production of packaging materials and systems. 

GMP regulations ensure that the entire product lifecycle, from development and production to labeling and storage, follows specific protocols aimed at consistently delivering safe and high-quality UK medicine packaging. 

Compliance with GMP standards is crucial for maintaining the integrity of medicines and preventing contamination or defects in the packaging. These practices encompass various aspects, including personnel training, hygiene, documentation, and equipment calibration. 

By adhering to GMP in UK medicine packaging, manufacturers uphold the highest standards of quality assurance, contributing to the safety and efficacy of medical products and reinforcing the trust of healthcare professionals and consumers in the integrity of the overall medicine supply chain.

Environmental Sustainability

In recent years, there has been a growing emphasis on environmental sustainability in UK medicine packaging. Regulatory agencies are encouraging medical companies to adopt eco-friendly packaging solutions, reducing the environmental impact of the industry. 

Manufacturers increasingly focus on adopting eco-friendly practices and materials to minimize their carbon footprint. This includes exploring recyclable, biodegradable, or compostable packaging options and optimizing packaging designs to reduce material usage. 

Additionally, efforts are being made to enhance energy efficiency in the production processes and choose environmentally responsible printing inks and coatings. The aim is to strike a balance between ensuring the safety and efficacy of medical products while minimizing the environmental impact associated with their packaging. 

By embracing sustainable practices, the medical industry not only aligns itself with global environmental goals but also responds to the growing demand from environmentally conscious consumers.

Smart Packaging and Technological Integration

UK medicine packaging in the 21st century vastly differs from the packaging used over a hundred years ago. In recent years, technological advancements have revolutionized UK medicine packaging, with smart packaging becoming the newest trend in the industry.  

Smart packaging refers to the emerging technologies within the packaging industry that increase consumer and business utility alike, all while simultaneously increasing the simplicity of accessing and tracking the information surrounding products and companies.

This packaging is equipped with features like temperature monitoring, NFC (Near Field Communication) tags, QR codes, and interactive labels. These innovations not only ensure the integrity of the medication but also empower patients with information and enhance overall healthcare management.

Innovation in UK Medicine Packaging – Automated Proofreading 

As the accuracy of all packaging content is of extreme importance, technological solutions that ensure packaging integrity are also increasing in popularity. Automated proofreading is one of those innovative solutions in UK medicine packaging. 

Automated proofreading aids in maintaining packaging accuracy by inspecting all types of regulatory content that would be present on UK medicine packaging. It helps companies uphold packaging and manufacturing standards with greater ease and efficiency, ensuring compliance with UK medicine standards and beyond. This technological innovation provides better proofreading results and enables higher-quality UK medicine packaging as it acts as an added layer of security in quality assurance processes.  

In essence, automated proofreading works by comparing two documents to find discrepancies between the two. The innovative software conducts comprehensive inspections and proofreads all packaging assets from text, color, graphics, barcodes, braille, and more. 

Through automated proofreading, inspections of packaging components are completed exponentially faster than traditional proofreading, and a task that once took hours or days to complete is now reduced to only a few minutes.

Benefits of Automated Proofreading 

Automated proofreading plays a crucial role in enhancing the quality and compliance of UK medicine packaging. Some ways in which automated proofreading helps in UK medicine packaging includes:

  • Error Detection: Automated proofreading quickly detects all potential errors on UK medicine packaging, ensuring the complete accuracy and quality of a product. This is not only important for regulatory compliance, it is also crucial for patient safety, as clear and error-free packaging guarantees critical medicine information such as ingredients, dosages, expiry dates, etc., are being accurately portrayed, preventing potential life-threatening consequences and ensuring patient and user health. 
  • Consistency Checking: Automated proofreading can verify consistency in terms of terminology, dosage information, and instructions across different sections of the packaging. Consistent information helps prevent confusion among healthcare professionals and patients.
  • Regulatory Compliance: UK medicine packaging must adhere to strict regulatory requirements, including specific language and formatting. Automated proofreading helps ensure that the packaging content complies with these regulations, reducing the risk of non-compliance issues, including fines, product recalls, and legal actions.
  • Efficiency and Speed: Automated proofreading significantly speeds up the proofreading process compared to manual methods. This efficiency is particularly beneficial in the fast-paced pharmaceutical industry, where accurate and timely product releases are critical.
  • Version Control: Automated proofreading tools can help manage version control, ensuring that the correct and most up-to-date information is included on UK medicine packaging. This is crucial for avoiding mistakes associated with outdated content.
  • Consistent Branding: For medical companies with multiple products, maintaining consistent branding across packaging materials is essential for brand recognition and trust. Automated proofreading tools contribute to ensuring this consistency.

By leveraging automated proofreading in medicine packaging, companies in the industry can improve the overall accuracy, quality, and compliance of their packaging. This not only increases patient safety but also helps maintain the integrity of medical products. 

Customer Case Study: Automated Proofreading For Error-Free Medicine Packaging 

Prior to implementing GlobalVision, all materials at Bristol-Myers Squibb (BMS) Shanghai were manually reviewed by their Quality Control department. Manually proofreading each packaging component often took too long and was too reliant on the SASS Project Manager. As they only relied on the human eye to catch errors, the risk of faulty inspections was high. 

For a major pharmaceutical company such as BMS, letting a critical packaging error slip by could have damaging effects on its reputation. It may also result in reprints or recalls which can impose huge costs on the business. Worse, it can cause potential consumer harm if these packaging errors made it to market. 

The BMS Quality Control Department uses GlobalVision to inspect incoming packaging materials such as cartons. Batch by batch, the packaging is compared to the approved samples to catch any differences between the two. As a result of the automation, the Quality Control  Department has found that its revisions could be completed faster and more effectively. 

Through the implementation of GlobalVision, BMS Shanghai increased its level of efficiency and accuracy, further aligning its commitment to quality when it comes to both packaging and patients.

The Future of UK Medicine Packaging

The transformation of UK medicine packaging throughout the years has been shaped by dynamic factors such as evolving regulations, changing consumer needs, technological advancements, and a heightened emphasis on safety and responsibility. 

The industry, from basic glass bottles to cutting-edge smart packaging, has consistently adapted to meet contemporary demands, with the MHRA playing a pivotal role in maintaining and enhancing these standards.

Each advancement in the industry shows a commitment to ensuring the highest quality and safety standards. Notably, the integration of technological solutions, including automated proofreading tools, emphasizes this commitment by improving accuracy and safeguarding packaging and, by default, healthcare professionals and consumers alike. 

Automated proofreading serves as a comprehensive solution that not only streamlines quality assurance processes but also facilitates accuracy and compliance for UK medicine packaging manufacturers and beyond.

To experience the transformative power of automated proofreading, request a demo of our innovative software and witness firsthand how this technology can revolutionize your daily business practices.

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Revolutionizing Braille Inspection: Introducing the Upgraded GVD Braille Module

Revolutionizing Braille Inspection: Introducing the GVD Braille Module

Date: December, 2023 | Category: Compliance | Author: Hana Trokic

In regulated industries, where adherence to standards and accessibility is crucial, Braille is a vital component of any product’s packaging or labeling to foster compliance and inclusivity.  

Braille, a universally accepted system of writing designed for individuals with visual impairments, is critical in ensuring that information, particularly in industries subject to strict regulations such as pharmaceuticals, is universally accessible. 

This code not only empowers individuals with visual disabilities by providing them with independent access to written content, but it also aligns with non-discrimination principles mandated by regulatory agencies. 

From a quality control perspective, Braille Inspection and accuracy play an important role as Braille is mandatory on pharmaceutical packaging all across Europe, and is strongly recommended by the FDA in Western markets, while other regions such as the ASEAN markets are working to heighten inclusivity by implementing braille requirements on packaging soon.

For regulatory industries to ensure the complete accuracy of their products, they need to ensure comprehensive revisions and inspections of their content. This includes text, graphics, barcodes, colors, and of course, braille for an all-encompassing quality control process. One way to ensure this accuracy is through modern-day technological solutions and innovations that ease these critical yet demanding revision tasks.

The New GVD Braille Module

One such innovation that stands out for compliance reviews is the newest upgrade from GlobalVision—the GVD Braille Module. This new braille inspection technology sets a new standard for fast, accurate, and comprehensive braille inspections. 

The GVD Braille Module allows regulated industries such as pharmaceuticals and print and packaging to automate braille height inspections with unparalleled granularity and speed, providing braille compliance data for each individual braille dot. This market-disrupting product brings unprecedented braille height detail, as well as meticulous braille translations to ensure complete accuracy and compliance with industry regulations across all printed assets.

This advanced technology is not just an upgrade in compliance inspections, it’s a breakthrough in braille inspection.

Here’s what to look forward to with the newest GVD Braille Module:

  • 10x faster inspections compared to traditional softwares
    • Example: DotScan on average takes 50 mins to complete a full Press sheet Braille inspection, while GlobalVision completes in less than 4 minutes with 2X the accuracy.
  • Eliminates the need for multiple systems, cutting costs and streamlining operations with all braille inspection features embedded within the robust GVD platform
  • Ensures braille labeling compliance with Marburg Medium Font Standard and ISO for medical products, preventing regulatory issues
  • Global scalability by inspecting braille translations in 44 languages 
  • Enhances braille inspections with detailed reporting on each individual braille dot across all regions, including multi-panel areas

Unmatched Braille Inspection Speed and Precision

With 10X faster braille height inspections and the support of full-size press sheets, GlobalVision’s newest automation technology surpasses the traditional DotScan software and all other competitors on the market. Printing & packaging and pharmaceutical companies can now expect to automate braille inspections with granularity and speed that was previously not possible. 

The technology not only accelerates the inspection process but also ensures unparalleled precision, reducing the risk of oversights. Beyond heightened efficiency, the increased automation of the entire compliance inspection process allows organizations to redirect resources to more strategic tasks, fostering innovation and growth internally. 

GlobalVision’s braille inspection technology redefines industry standards by combining speed and granularity, transforming compliance inspections into a faster, more comprehensive and accurate process.

Save Resources and Eliminate Unnecessary Overhead

With this new release, all braille inspection features are embedded within the robust GVD platform. This allows companies in regulatory industries to save money and resources by eliminating the need and overhead of managing multiple systems. 

The GVD Braille Module consolidates all packaging quality control processes as it is fully embedded within the robust GVD system, allowing for text, graphics, barcode inspections and more, rendering the use of a separate system obsolete.

This upgrade ensures that every aspect of your quality control process can be seamlessly executed within a single platform. The efficiency gains are unmatched, as companies can now navigate the entire process, including the previously tedious braille inspection, with speed and precision, while simplifying their workflows and enhancing overall productivity. 

This innovation not only streamlines operations but also positions the GVD Braille Module as an industry leader, offering unparalleled ease and efficiency to the market. 

Ensure Adherence to Compliance Regulations

For regulated companies, the need to adhere to strict guidelines and requirements is critical. GlobalVision’s latest advancement in braille inspection technology represents a crucial upgrade in addressing this concern by guaranteeing ongoing braille compliance with the Marburg Medium Font Standard as well as the ISO 17351:2013  requirements for braille labeling on medicinal products. 

This upgrade not only ensures precision and accuracy in braille, but, more importantly, serves as a proactive measure to prevent potential regulatory sanctions. By aligning seamlessly with established standards, this technology provides regulatory companies with the assurance that their braille labeling processes are not only efficient but also in strict accordance with mandated guidelines, protecting against potential legal and regulatory penalties. 

Global Scalability

The GVD Braille Module isn’t confined to a specific language or region. It scales globally, inspecting braille translations in an impressive 44 languages against a master file. This global scalability ensures that the technology is not only cutting-edge but also inclusive and diverse, catering to the many linguistic needs of multinational enterprises. 

By accommodating such a wide linguistic range, the GVD Braille Module becomes a versatile tool that addresses the diverse needs of companies worldwide, acting as a positive lever toward their global expansion strategies. 

Detailed Reports and Compliance Data

One of the standout features of the GVD Braille Module is its ability to provide you with highly detailed reports for each braille dot across all regions, ensuring that every single dot meets regulatory standards.

The GVD Braille Module allows you to achieve unprecedented granularity in braille inspections with in-depth reporting for each individual braille dot across all braille regions, including multi-panel regions. This means the software goes beyond basic inspection data and provides a level of inspection scrutiny unparalleled in today’s market. 

 

The Future of Braille Inspection

In an era where technology and automation is the driving force behind progress, the GVD Braille Module stands out as a revolutionary solution in the field of braille inspection. This comprehensive solution surpasses all previous inspection systems and doesn’t just meet industry standards but sets a new benchmark for efficiency and accuracy. 

As industries strive for greater innovation in technological solutions, the GVD Braille Module allows you to overcome all previous inspection limitations and embrace new technology that improves the entire quality control process. 

GVD Braille Module is not just an upgrade, it’s a revolution in braille inspection. To try the new standard in braille inspection yourself, book a personalized braille demo and begin revolutionizing your compliance inspections today.

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Dempsey Corporation Transforms the Label Review Process with GlobalVision

Date: November, 2023 | Category: Customers | Author: Hana Trokic

About Dempsey Corporation

With over 35 years of experience in the consumer goods industry, the Beauty Division of Dempsey Corporation understands the complex needs of customers when it comes to product development, sourcing, quality assurance, and logistics. 

Located in Toronto, Ontario, Dempsey’s Beauty Division is a private label that produces an array of products under common retail brand names. With a commitment to going above and beyond for their customers, Dempsey recognizes the importance of a strong quality control process.

Today, Dempsey is represented by a diverse group of international experts based in five countries with the one main goal of delivering value. 

The Challenge: Ensuring Accuracy of Large, Complex Files 

Prior to implementing digital quality control, the company was outsourcing specific elements of the label review process. Numerous label versions were created with label workflows interchanging between internal teams, clients, and packaging producers. 

For Dempsey Beauty’s quality assurance team, this led to difficulties in managing approvals, especially with regard to ensuring that all teams were using the most recent and relevant version of a file. 

What’s more, with product labels containing large ingredient lists which are very text-heavy, manual proofreading became increasingly difficult, especially when the team started succumbing to proofreading fatigue, occasionally missing some content errors as their eyes started to adapt to the content. Ultimately, these errors often resulted in financial losses as well as reputational damage.

Before implementing GlobalVision, the majority of proofreading fell into the hands of one person to review labels at the regulatory and quality assurance levels. This created a vulnerable and risk-prone step in their process, as the onus fell on the proofreader – a single person who mainly relied on the human eye for quality control. 

To help reduce the risk of human error and assure the accuracy of their large volume of labels and content, Dempsey decided a change was needed in their quality control process to ensure  the credibility and accuracy of their products, and maintain their position as a leader and household name in the beauty industry. 

The Solution: Replace Error-Prone Label Review Processes with Accurate Automated Solutions

After exploring various solutions on the market, Dempsey Corporation made the decision to  incorporate GlobalVision into their quality control processes to eliminate errors and fatigue caused by manual proofreading. 

They decided to implement this automated solution as an additional layer of review, giving them peace of mind and allowing them to focus more efforts on other important  areas of quality assurance. 

Additionally, Dempsey’s Beauty Division wanted to improve their market position and stand out against competitors, and they felt that implementing GlobalVision would contribute to their success in this area. “It’s the gold standard of quality assurance, to be able to assess a label with the same level of scrutiny regardless of the number of labels there are and how tired your eyes might be,” says Charles Inthathirath, the Quality Assurance Manager at Dempsey’s Beauty Division.

The Result: Increased Productivity With GlobalVision’s Automated Software 

After implementing GlobalVision’s Quality Inspection Platform, the company has benefited from significant time-savings along the entire quality control process. In high season, Dempsey’s quality department can use the GlobalVision software to replace half a day’s worth of label reviews, allowing them to review more labels in a shorter time period. 

When it comes to replenishing inventory in the production phase, having GlobalVision has been a huge help in approving labels that are in queue for print.

Aside from accelerating text-heavy reviews, the quality team appreciates GlobalVision’s barcode inspection tool, especially the human-readable value and grade provided by the software, which allows them to ensure that barcodes are always compliant with industry regulations before they go to print. . “Overall, the software is great! We also appreciate the extra training available to us,” says Inthathirath. 

They’ve been able to measure the success of implementing GlobalVision by measuring their productivity levels. With GlobalVision in place to help improve the efficiency of their  label review process, the quality department has been able to allocate resources to other areas of quality assurance and they’ve seen an increase in efficiency across the board.

Looking Ahead with GlobalVision

As they look towards the future, the company sees itself moving forward by expanding their beauty line to include eye products while also pushing towards more environmentally friendly and sustainable packaging. 

Going above and beyond to meet and exceed the needs of their customers will always be top priority for Dempsey’s Beauty Division. That is why they continue to use GlobalVision in their label reviews to ensure the complete accuracy, credibility and quality of every product that goes out to the market. 

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A Beginner’s Guide to Sustainable Packaging

A Beginner’s Guide to Sustainable Packaging

Date: November, 2023 | Category: Quality | Author: Hana Trokic

While “going green” may be a proud point for many businesses in this day and age, in the world of packaging and design, it’s not necessarily going far enough. Instead, it’s all about being sustainable. 

However, true sustainability doesn’t just take into account the materials that go into packaging. True sustainability also considers potential waste during the production process. When introducing end-to-end sustainability, businesses need to look back to the very beginning, to the point where the packaging is designed and then approved.

It is important to note that the packaging approval process can result in many rounds of revisions until everything is ready for production. The result can create wasted resources if your process isn’t as tight as possible, even if the packaging itself is 100% sustainable.

As a result, significant resources get wasted when mistakes slip through your supply-chain cracks. Avoidable errors can result in recalls leading to heaps of wasted packaging that have no value. For perspective, in 2015 alone, 77.9 million tons of municipal solid waste generated in the United States consisted of containers and packaging. Over one-third of that total ended up in landfills.

Read on to discover how to create truly sustainable packaging and processes for your business.

What Is Sustainable Packaging?

While a product that’s labeled as “green” carries a positive, eco-friendly connotation, it’s vague by standards set by the Federal Trade Commission. 

For example, “green” generally means one or some combination of the following:

  • Compostable
  • Degradable
  • Non-toxic
  • Ozone-safe/ friendly
  • Recyclable
  • Made from recycled content
  • Made with renewable energy
  • Made with renewable materials
  • Refillable

“Green” may sound satisfactory, but each of the above actually conveys something tangible. According to Diana Fryc, Director of Operation of Retail Voodoo, using compostable packaging is just one step.

“Aside from compostable packaging, there is still a strong desire to reduce the size of packages, continued desire to use fewer adhesives, and continued use of the post-consumer recycled material,” she says. “Lighter materials to save on shipping costs and form factors that maximize shelf space bottles will also continue.”

In fact, packaging that’s “sustainable” is understood to meet a long list of specific criteria, featuring many of those same characteristics. To further illustrate this point, the Sustainable Packaging Coalition has developed its own criteria for what defines sustainable packaging:

  • Sourced from materials that each remain healthy throughout the lifecycle
  • Manufactured using clean technologies and best practices, to optimize materials and energy, thereby meeting/exceeding competitive performance and cost standards
  • Transported efficiently via fossil fuel alternatives, helping to develop renewable energy markets
  • Recycled, recovered, and utilized in closed biological/ industrial loop cycles

Of course, the International Organization for Standardization (ISO), the Consumer Goods Forum, and CEN all have alternative packaging standards. So, globally speaking, there aren’t any hard, fast rules for what constitutes sustainable packaging. There are, however, certain guidelines. 

Following them is far from easy, but this guide will help you understand the basics as you maneuver through the complex world of sustainable packaging and its implementation. 

Reducing Your Carbon Footprint

Ultimately, by introducing sustainable packaging into your supply chain, businesses are aiming to reduce their carbon footprint as a whole. This includes securing product packaging workflow through effective quality control. 

Preventing recalls by catching errors means less packaging, less waste, and therefore, a lot less energy consumed. After all, the resources needed to carry out recalls, which cost on average $10 million in the food industry, don’t include the transportation and labor costs of putting more packaging through your supply chain and re-shipping the product. It all affects your bottom line and the packaging footprint you’re trying to market as sustainable.

Therefore, it’s time to start looking beyond the product and at the complete end-to-end process. Many companies are integrating new technologies and automated systems that can spot errors before going to print as a pre-emptive strike against recalls. The main goal is to address sustainability, as it’s important to consider how products are made and how to be as efficient as possible with the resources available.

It turns out the idea that integrating sustainable packaging leads to higher costs is actually a myth. Studies show that companies that look to become more eco-friendly overall enjoy as much as an 18% return on investment increase. That’s potentially a lot of green for going green.

Have you heard about footprint packaging? Learn more by reading our detailed blog post. 

The Need for Sustainable Packaging

There’s little denying the benefits of sustainable packaging. There are financial benefits in store for any corporation moving in that direction. That’s not just due to the increased back-end efficiency and economies of scale that result from such a move. 

If marketed correctly, sustainably packaged products have been proven likely to sell more.

Obviously, a company shouldn’t make the switch simply to appease its conscience. All things being equal, it just makes sense to waste less and promote a brighter future filled with less waste. 

“Packaging is a polluting factor” says Andreas Kioroglou, the CEO of Matador Design. “Creative design will [start to] take into account factors like the reduction of the carbon footprint of packaged goods throughout the supply chain and designs that will extend the packaging life cycle.”

Read what more experts are saying about sustainable packaging here.

Over the long term, it is expected that sustainable packaging solutions will lead to higher profits relative to one’s current process. The only thing holding companies back is the inevitable, albeit short, discomfort that results from transitioning to a new and improved process.

Implementing Sustainable Packaging

Packaging plays a crucial role in influencing customers’ buying behavior, yet unsustainable packaging can damage the reputation of a company, causing customers to switch to other brands that employ environment-friendly materials and processes. 

Implementing Sustainable Packaging

Unsustainable packaging is detrimental to the environment as it increases the amount of waste that is diverted to landfills, causing increased greenhouse gas emissions.

Sustainable packaging can reduce our ecological footprint at all stages of the product life-cycle, helping the manufacturer and the customer work towards a sustainable future.

With sustainability being the major agenda for almost all countries around the globe, several organizations are introducing sustainable packaging in order to reduce the negative impact on the environment and differentiate themselves from the competition. 

However, the industry is not devoid of misconceptions that could cause confusion, making it challenging for organizations to work toward a sustainable future.

Sustainable Packaging Is An Added Cost

It is a common belief that a majority of product improvements come with a high price tag. Though the cost of sustainable packaging may seem to be high initially, it offers numerous benefits that contribute to the long-term success of a business. Moreover, socially responsible businesses incorporate the extra cost of sustainable packaging as a part of their business plan, assuring them of profits in the long term.

Adopting sustainable or green packaging enables marketers to connect with their eco-conscious and green-aware consumers, giving them a competitive advantage and boosting profits. In fact, studies conducted by the Carbon Disclosure Project (CDP) prove that organizations that adopt eco-friendly materials and processes are likely to see a return on investment of 18 percent or more.

Apart from attracting new customers and boosting your corporate image as an environmentally-responsible organization, sustainable packaging also offers innovative designs that can be tailored to the clients’ specific requirements.

For instance, waste can be recycled using the paper molding process and converted into customized packaging in order to meet the firm’s requirements for heavy and delicate products at an extremely affordable rate. All this eliminates excessive packaging, making the shipments light and drastically reducing the products’ footprints on the store shelves.

Additionally, in recent times, brands cannot afford to ignore eco-friendly strategies. Consumers increasingly prefer products that protect the environment, reduce global warming, and prevent air and water pollution. 

Consequently, both emerging and advanced markets are drifting towards ethical and environment-friendly options, pushing designers, marketers, and package development experts to meet the right social and environmental standards.

Most countries also offer special subsidies and incentives for businesses that are looking to join the sustainability bandwagon. Moreover, firms going the sustainable way also enjoy preferential terms and tax rebates from the state and local authorities for setting up an environment-friendly business.

Thus, green packaging actually stands to save money by reducing material and shipping costs and minimizing waste, playing a persuasive role in helping customers choose your brand over the competition.

Sustainable Packaging Choices are Limited

With the growing concern regarding waste being diverted to landfills and the ensuing greenhouse emissions, customers are expecting firms to use eco-friendly elements in their products. 

Consequently, packaging firms have come up with several innovative and green materials, namely polylactic acid (PLA), bagasse, recycled paper, and post-consumer polystyrene that can be used to manufacture coffee cups, plates, cutlery, and boxes.

For instance, Evocative, a New York-based biomaterials firm developed a mushroom-based material that can be used as an alternative to plastic packaging. Similarly, Biopac, a UK-based bioplastic developer uses polylactic acid (PLA) from renewable plant sources to manufacture compostable cups and food packaging.

Sustainable Packaging Adds to Waste

Sustainable packaging is not merely about the eco-friendly nature of the final product. Instead, it means that the packaging material is made from biodegradable, reusable, and environmentally-safe matter and uses energy-efficient manufacturing procedures and health-friendly working conditions for the staff involved.

Sustainable packaging helps firms streamline the packaging design, eliminating unnecessary material from the processes and creating less packaging-related waste. Materials such as biodegradable plastics, plant-based plastics, and recycled products are used to develop sustainable packaging, making it possible for manufacturers and consumers to reduce the amount of waste being diverted to landfills and the ocean floor. 

For instance, molded fiber products, namely egg trays, fruit-and-vegetable trays, compostable plant holders, and wine shippers are made using biodegradable waste procured from recycling companies and individual households.

Sustainable Packaging is Unappealing to Consumers

Most commonly, when people think of sustainable packaging they envisage a dull brown or cream paper with visible reused fibers. However, technology has made it possible for design firms to come up with innovative packaging that harnesses powerful aesthetics and is environment-friendly at the same time. 

Many international brands and powerhouses such as Samsung, Zara, and Puma offer attractive packaging yet use 100 percent eco-friendly material, preserving the planet and its natural resources.

Want to learn more about sustainable packaging myths? Click here to read our in-depth blog post.  

Transitioning to Sustainable Packaging

While some companies are already fully onboard the sustainable packaging bandwagon, others are either on route to making the transition or have yet to make a firm decision on the matter.

For the companies already in existence, it’s about altering the course. Once you’ve committed to making the leap, it’s important to determine your ultimate goals. While the Sustainable Packaging Coalition’s criteria favor a circular economy (or closed loop, which relies on renewable energy), it’s by no means the only choice.

Another is to develop packaging with a linear lifecycle. There, packaging ultimately ends up as trash instead of biologically degrading. It can also be considered eco-efficient, depending on other production factors. It also means bigger short-term gains. The closed loop means more risk and long-term investment, but a higher potential payoff through legitimately sustainable packaging.

Here are some tips to help execute a proper sustainability strategy:

  • Get buy-in: Empower employees to take charge and get more emotionally invested in the outcome of the change in strategy. Businesses can also get buy-in from the public. Communicate the change in your corporate philosophy. Done right, it can only improve your image as a forward-thinking company.
  • Choose the right materials: It goes beyond selecting materials that are recyclable or even materials that are renewable. While renewable feedstocks are one sustainable direction in which to go, there are other things to consider. For example, how their functionality compares to that of traditional materials. “Sustainable” is great, but it means little if the packaging doesn’t do what it needs to.
  • Get to designing: It will be a long process, but thoroughly evaluating each required packaging component will go a long way toward ensuring an overall sustainable design. Simple ones, made from single materials without secondary and tertiary packaging, are easily disassembled and recyclable. That also means minimal glue when possible. Creating packaging that is reusable and multi-functional also wins market points from a sustainability perspective and with consumers.
  • Invest in quality control: Quality control processes are critical, especially when rolling out dramatically different packaging that can contribute to product spoilage. Automating quality control and eliminating proofing fatigue, human error, and errors in general, can also contribute to long-term sustainability.

Automation to Sustainability 

Automated quality control tools are indispensable assets for businesses striving to enhance their sustainable packaging processes. These tools, driven by cutting-edge technology offer multifaceted advantages that extend far beyond mere error correction. 

In the context of sustainable packaging, precision is paramount. This software meticulously scans through all packaging-related content, including labels, product descriptions, usage instructions, and promotional materials, ensuring that they are free from spelling, grammar, and formatting errors. By maintaining a high standard of accuracy, businesses reduce the likelihood of recalls, reprints, and costly product corrections, directly contributing to a more efficient and eco-friendly production process.

Automation to Sustainability

By preventing errors, reducing rework, and promoting sustainability, automated proofreading software helps minimize waste in the production process and optimize resource utilization. They aid in curbing the overuse of materials and energy while contributing to the reduction of the carbon footprint associated with packaging. 

In the eyes of environmentally-conscious consumers, these efforts resonate as a genuine commitment to sustainability, ultimately enhancing a company’s brand reputation and its competitiveness in the market.

Automated quality control is not just about catching typos; it’s a vital enabler in a business’s journey toward sustainable packaging. The software streamlines operations, reduces costs, encourages green thinking, and helps businesses establish themselves as responsible actors in environmental protection and sustainability.  

As sustainable packaging gains increasing importance in today’s eco-conscious world, this technological solution is becoming an indispensable instrument for companies committed to both excellence and environmental consciousness. 

A Sustainable Future 

The global packaging and protective packaging market was valued at $1.0 trillion in 2021, and is projected to reach $1.5 trillion by 2031, which would result from steady year-over-year growth.

Innovation will logically end up being one driver of that valuation, just as it is currently in the manufactured goods sectors directly reliant on it. That’s simply the nature of a free-market economy in which consumers reward the cutting-edge.

As a result, it’s no longer a matter of going green. It’s arguably not even about going sustainable. It’s about striving to reach sustainability. As the exact definition of “sustainable” is a fast and moving target, it’s more a matter of taking steps towards attaining that goal.

In a period of just three years, the number of firms listed on the S&P 500 that included sustainability issues in their Securities and Exchange Commission filings increased from 5% to 25%. That in and of itself may not be a testament to how successful sustainability can be, but it is of how the times are becoming more eco-friendly.

A sustainable future

Joining in on the success means changing with the times, or, perhaps more accurately, adapting. Both customers and the companies behind the products they consume stand to benefit from the large-scale evolution of packaging, which is taking place right before our eyes.

If you would like to take a step into implementing sustainable packaging into your business, start by implementing smart, technological solutions that can easily help you get there. Automated quality control is a comprehensive solution that will not only streamline your proofreading and quality assurance processes, it will also help your business achieve true sustainability with far greater ease. 

Request a demo of our innovative proofreading software and see how this technology can revolutionize your every day, sustainable business practices. 

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Compliance in Medicine Post Brexit: Everything You Need to Know

Compliance in Medicine Post Brexit: Everything You Need to Know

Date: November, 2023 | Category: Compliance | Author: Hana Trokic

As we continue to process the historic decision of the United Kingdom to exit the European Union, commonly known as Brexit, its far-reaching implications continue to unfold across various sectors. In terms of healthcare and pharmaceuticals, the repercussions are expected to be particularly noticeable and profound. 

After years of negotiations and political turbulence, Brexit, which officially came into effect on January 31, 2020, has cast a shadow of uncertainty over the pharmaceutical industry in the UK and the EU.

The intricate web of Brexit’s impact on medicine compliance, pharmaceutical trade, and regulatory frameworks is yet to be fully understood but one thing is for certain – it’s multifaceted and intertwines issues of access to medicines, the integrity of pharmaceutical supply chains, and the development and approval of new drugs.

From supply chain disruptions stemming from customs and border checks to evolving drug approval processes as the UK establishes its own regulatory path, we look at how this shift is reshaping the landscape of medicine compliance and pharmaceuticals in the UK and EU.

By navigating the complexities and challenges faced by pharmaceutical companies, healthcare providers, and patients, read on to learn more about the strategies and adaptations emerging in the post-Brexit era to ensure the continued delivery of safe and effective medicines to those who rely on them.

Medicine Compliance in the UK Post Brexit

One of the immediate concerns that surfaced with Brexit was its impact on medicine compliance. Prior to Brexit, the European Medicines Agency (EMA) played a central role in regulating and approving medicines across the EU, including the UK. However, with the UK’s departure, the country’s Medicines and Healthcare Products Regulatory Agency (MHRA) became a stand-alone body as it ceased to be part of the European system of approval. 

This transition led to a series of challenges, including the need for pharmaceutical companies to duplicate their efforts by submitting separate pharmaceutical applications to both the EMA and MHRA for approval.

This duplication not only increased regulatory burdens but also posed questions about the consistency of medicine approvals and what compliance is in medicine post Brexit. 

Patients and healthcare providers needed assurance that the medicines they relied on remained safe and effective. Consequently, many pharmaceutical companies undertook the arduous task of adapting to these new compliance requirements, investing time and resources to ensure a seamless transition.

The Pharmaceutical Trade Landscape

The pharmaceutical industry relies heavily on global supply chains, making it particularly vulnerable to disruptions caused by Brexit. The imposition of customs and border checks created bottlenecks and delays, affecting the timely delivery of vital medicines to patients on both sides of the English Channel.

Pharmaceutical companies were forced to reevaluate their supply chain strategies, with some choosing to stockpile medicines to mitigate potential shortages. However, stockpiling is not a sustainable long-term solution and comes with its own set of challenges, including increased storage costs and the risk of medicines expiring before use.

Moreover, the UK’s departure from the EU single market and customs union introduced new regulatory barriers to pharmaceutical trade and new medicine compliance rules. Companies had to navigate complex rules of origin, tariffs, and customs procedures, all of which added to the cost and complexity of doing business. 

To address these challenges, some pharmaceutical firms explored the possibility of relocating parts of their operations to the EU to maintain access to the single market. This then leads to the potential of further economic consequences for the UK as valuable companies and jobs are no longer located on English territory. 

Parallel Importation

Another challenge that arose was the stricter regulations regarding parallel importation.  

Parallel importation refers to the practice of importing pharmaceutical products from one country to another within the European Market Area (EMA) to take advantage of price disparities. After Brexit, the UK is no longer part of the EU single market, meaning parallel importation became significantly harder. 

They are now subject to stricter medicine compliance regulations and have to apply for licenses to import goods that could have easily been shipped throughout the Euro Zone prior to Brexit. In the future, this could affect the availability of certain medicines and their cost in the UK.

Customs and Supply Chain Disruptions

While exiting the EU made certain things easier for the UK, it certainly also introduced many more regulations and complications with regard to trade between the two European territories.  

Brexit introduced customs checks and border controls between the UK and the EU, which has been shown to lead to supply chain disruptions for pharmaceutical companies. Delays in transporting raw materials and finished products can, and to an extent, have impacted the availability of medicines on both sides of the border. 

Pharmaceutical companies have had to adjust their supply chain strategies to mitigate these challenges, but the potential for even more disruptions remains a large concern.

The Evolution of Drug Approval Processes

Brexit also prompted a shift in the landscape of drug approval processes. 

The UK now had the opportunity to develop its own medicine compliance regulatory framework, separate from the EMA. While this could potentially streamline decision-making and reduce bureaucracy, it raised concerns about the duplication of efforts and the potential for divergence in standards between the UK and the EU.

To mitigate these risks, the UK and EU agreed to a medicine compliance regulatory cooperation framework, ensuring continued information sharing and collaboration on drug approvals. However, challenges remain as the two entities adapt to their new roles and responsibilities in this post-Brexit era.

Pharmacovigilance and Safety Reporting

Pharmacovigilance, the monitoring of the safety of pharmaceutical products once they are on the market, is a crucial part of the pharmaceutical product lifecycle, and another area affected by Brexit. 

The UK and the EU now have separate pharmacovigilance systems, leading to the need for separate safety reporting and data management processes. Ensuring seamless cooperation and information exchange between these systems is crucial to maintaining patient safety and medicine compliance. 

Yet, with the additional regulations being placed after Brexit and the further complication of the entire process, the chance of errors occurring is higher, therefore, the need to mitigate them is also a larger concern. 

Medicine Compliance Strategies and Adaptations

In the face of these medicine compliance challenges, pharmaceutical companies, healthcare providers, and patients have to quickly adapt to the post-Brexit reality. 

Strategies to ensure the continued delivery of safe and effective medicines include:

  • Diversifying Supply Chains: Many pharmaceutical companies are diversifying their supply chains, reducing their reliance on a single source for critical components and ingredients. This strategy enhances resilience and reduces the risk of disruptions.
  • Investing in Regulatory Expertise: Companies are investing in regulatory expertise to navigate the complexities of dual regulatory systems. This includes hiring regulatory professionals and consultants to manage compliance effectively.
  • Collaboration: Collaboration between pharmaceutical companies, regulatory authorities, and healthcare providers remains crucial. Information sharing and cooperation can help address challenges and ensure a smoother transition.
  • Patient Education: Patients are being educated about potential changes in the availability of their medicines and are encouraged to consult with healthcare providers to explore alternative treatments or solutions.
  • Advocacy and Lobbying: Pharmaceutical industry associations are actively engaging with policymakers to advocate for policies that support the smooth flow of medicines and reduce trade barriers.

Document Comparison Software: The Ultimate Post-Brexit Strategy 

Along with the strategies mentioned above, document comparison software offers significant advantages in the domains of medicine compliance, pharmaceutical trade, and post-Brexit regulatory adherence. 

It aids medical facilities in maintaining – medicine compliance by ensuring the accuracy of regulatory content, supporting version control, and facilitating audit readiness. In the pharmaceutical sector, in particular, it helps companies uphold product labeling and manufacturing standards, ensuring compliance with international trade regulations and reducing the risk of trade disruptions. 

Moreover, document comparison software plays a pivotal role in adapting to post-Brexit medicine regulations by ensuring legal compliance, monitoring trade agreements, and mitigating risks associated with regulatory changes. Its ability to swiftly identify inconsistencies and compliance gaps makes it an invaluable tool for navigating these complex and highly regulated industries.

How to Ensure Medicine Compliance With Document Comparison Software?

Here’s how document comparison software can help in post-Brexit medicine compliance regulatory adherence:

  • Regulatory and Medicine Compliance: Document comparison software can assist in ensuring that medical documents, such as patient records, compliance documents, and regulatory submissions, are up to date and aligned with the latest healthcare regulations. This is crucial, as non-compliance can lead to legal issues and harm patient care.
  • Version Control: The software helps in managing version control of critical documents, making sure that the latest and approved versions of documents are being used by quality assurance teams. This ensures that pharmaceutical documentation, packaging, and labeling, remain compliant with evolving regulations.
  • Audit and Inspection Support: The pharmaceutical industry is regularly audited and inspected. Document comparison software can help in preparing for audits by identifying any inconsistencies or non-compliance issues in advance, reducing the risk of compliance violations.
  • Product Labeling and Packaging: In the pharmaceutical industry, accurate labeling and packaging of products are essential. Document comparison software can ensure that product labels and packaging materials comply with international trade regulations, reducing the risk of product recalls or trade disruptions.
  • Batch Records and Manufacturing: Pharmaceutical companies can use document comparison software to ensure that batch records and manufacturing processes adhere to quality and safety standards, which are critical for successful international trade.
  • Regulatory Submissions: Companies can use the software to compare regulatory submissions before and after Brexit to ensure that they are in compliance with the new post-Brexit regulations. This reduces the risk of regulatory issues and trade disruptions.
  • Legal Compliance: Document comparison software can be used to compare legal documents before and after Brexit, ensuring that new documentation is updated and accurate and that companies are aware of and adhere to the new regulations and trade agreements that have come into effect.
  • Trade Agreements: The software can help companies in the pharmaceutical and medical industries ensure that they are in compliance with any new trade agreements or tariffs that have been established as a result of Brexit.
  • Risk Mitigation: By regularly comparing documents with the latest, updated versions, organizations can identify and address compliance gaps or inconsistencies promptly, reducing the risk of legal issues and trade disruptions.

The Future of Pharma and Brexit 

Brexit has undeniably cast a shadow of uncertainty over the pharmaceutical industry, but it has also spurred innovation and adaptation. As pharmaceutical companies, healthcare providers, and patients navigate the complexities of medicine compliance, supply chain disruptions, and evolving regulatory frameworks, the resilience and determination of the industry to ensure access to safe and effective medicines remain unwavering.

While the full implications of Brexit on healthcare and pharmaceuticals are still unfolding, the commitment to safeguarding the health and well-being of patients on both sides of the English Channel remains of the highest importance. 

The post-Brexit era presents an opportunity for the industry to demonstrate its adaptability and dedication to delivering vital medicines to those who rely on them. One way in which they can ensure this is through the implementation of efficient, streamlined, and error-free processes. 

Implementing document comparison software in regulatory and quality assurance processes can help maintain medicine compliance, ensuring that documentation and pharmaceutical processes adhere to evolving healthcare regulations with complete ease while giving regulatory professionals peace of mind that no errors are slipping through.

Take a step in the right direction by setting up proper processes through document comparison software. Visit our Demo Center to learn more about our products at your own leisure and see how this technology can revolutionize your everyday business and regulatory practices. 

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