An illustration of a stairway between 2 structures

Date: July 28, 2020 | Category: Quality | Author: Kayla Caticchio


Now more than ever, the demand for safe and effective medical drugs is increasing on a global scale. This means that regulatory affairs teams are working overtime to interpret, apply, and communicate the guidelines received from governing bodies like the FDA and EMA when it comes to developing new drugs. And when medical drugs are approved, they must then be made available for use on a global scale. As a result, all content must be adapted to meet the legal and cultural requirements of markets beyond the country in which they were produced.

As market sizes expand, pharma companies must coordinate localization for every product they release. More than just translations, this includes adjusting elements like color, date formats, units of measurement, and artwork to reflect various markets. All content like leaflets, cartons, inserts, and legal documentation must also be fully adapted, creating challenges for regulatory teams when combined with the speed in which products must be released.

Technology for the pharmaceutical workflow

A key way to effectively manage the increasing workloads as a result of globalization is to harness technology that allows regulatory affairs teams to operate at scale. When it comes to proofreading, manual processes are no longer efficient given the speed and complexity in which products must be delivered.

With a digital quality control system, proofreaders and RA teams can verify content accuracy on digital files and printed packaging components, eliminating inefficiencies at every stage of the pharmaceutical workflow. To begin, product requirements are submitted to regulatory bodies who then compile the information into briefing documents. At this stage, a digital quality control system would ensure that all copy documents are error-free and accurate for internal revisions.

At the artwork creation stage, artwork files can be automatically inspected to make sure that no errors were introduced during the file creation process. Examples of errors that could be created during this stage include logo errors, incorrect product information, and barcode defects. At the final stage, a digital quality control software can automatically compare approved files to supplier proofs before going to print, ensuring that products make it to market with packaging that is entirely error-free.

Foreign languages & data compliance

Managing content in foreign languages is another challenge for regulatory teams in the pharmaceutical industry. As medical products make their way into foreign markets, all materials and content must be properly translated into multiple languages which creates significant room for error. Technology solutions can help effectively manage this by improving document management, version control, and quality assurance through automated proofreading that supports many foreign languages. 

Along with accurate foreign translations, following compliance and data integrity guidelines is essential in the pharmaceutical industry. Digital quality control tools utilize audit trails and reporting features to track all activities, ensuring compliance with bodies like ISO certifications, 21 CFR Part 11, and Annex 11. These tools help protect data integrity by providing full traceability on who ran an inspection, the inspection results, and what changes need to be made.

As the nature of regulatory standards continues to evolve, so does the need to effectively implement technology solutions like automated quality control. These technology solutions not only improve processes between teams, but they also increase cross-functional collaboration and give pharmaceutical companies the tools they need to operate on a global scale.

To learn more about how technology can help manage regulatory compliance, check out GlobalVision’s guide Digital Transformation for Pharmaceutical Packaging Quality.

Date: April 28, 2019 | Category: Compliance | Author: Ryan Szporer


It’s a year into life post-GDRP. Amazingly, the world goes on. In fact, the General Data Protection Regulation in the European Union has gone according to plan, to the point that similar legislation is being considered in other parts of the world, including the United States.

Good and Bad Data Privacy News

That’s good news. In fact, the first steps have been taken in the U.S. towards their own federal version eventually being adopted. The California Consumer Privacy Act comes into effect starting in 2020, while privacy laws in 13 other states are in the process of being adopted too.

From the get-go, it would have been a huge mistake for any U.S. company to assume GDPR was an overseas problem that wouldn’t ever affect them. After all, it technically did already. If GDPR’s rules, which dictate how the private data of Europeans should be handled, are broken by a firm, regardless of where it is located in the world, stiff fines could be incurred. Companies in the hospitality, travel, software services, and e-commerce industries are likelier than others to be affected.

With specific regard to the latter two sectors, as data integrity and privacy becomes an ever-growing concern, the issue is only going to gain momentum en route to it becoming a mainstream problem in America requiring a country-wide resolution. Plus, if American companies are going to have to make privacy concessions for their European customers, it makes sense to do the same for the ones back home, especially if they’re likely going to have to eventually.

Becoming as Good as GDPR-Compliant

In such an instance, some U.S. companies have some idea of what to do, having taken steps to comply with GDPR already. For those who haven’t, there’s no time like the present. Granted, one well-enrolled school of thought argues firms shouldn’t worry about trying to predict the future and to keep on as they normally would until laws are passed and they know exactly how to proceed.

In other words, don’t try to predict the future, because you very well could end up being wrong. Plus, even if you could, you wouldn’t even need to in this context. You’d be sipping a margarita on your own private island, having just won the lottery for the 12th time.

Admittedly, it’s true: Individual rules could frustratingly vary from state to state, once privacy laws in the States become more of a norm. However, the basic principles remain the same, especially with increasing calls for interoperable laws. In such an instance, a Californian, for example, would be able to realistically expect their data to be similarly protected if it travels outside state limits.

Take it from the CEO of Teemo, a Paris-based tech company specializing in location data that holds the dubious honor of being the first firm to officially get called out for not being GDPR-compliant. Benoit Grouchko, whose company has since rectified the situation, says a wait-and-see approach doesn’t work, especially since many of these policies should be best practices, regardless. That includes being more transparent with consumers and getting rid of data you’re not using.

Chances are good consent would be required for every bit of info anyway under the new world order. For example, under GDPR, companies cannot collect data without knowing how they will use it, nor can they reuse data they initially collected for another purpose.

Privacy by Design… Consumer-Friendly Too

Ultimately, the most successful companies will be the ones who were arguably compliant to begin with, namely those who embraced a “Privacy by Design” approach when building up their brand equity. There’s still hope for those who didn’t and took lax data privacy laws for granted, obviously. Moving forward, as Grouchko advises, make opting out as easy as opting out. Companies have a lot less to lose than if they don’t. Even if they missed out on the chance to gain a competitive edge, they have to get going eventually, because it’s undeniably where everything is headed.

These are just some basic principles that would arguably hold true regardless of the exact nature of any forthcoming laws in the U.S. All the same, there are things the U.S. might want to do differently if the trend ever gets to the point that it truly becomes a nationwide phenomenon. Whereas GDPR requires companies to appoint someone specifically to keep up to date with regulations, it amounts to one more expensive undertaking in the struggle to stay compliant, keeping someone on board who doesn’t directly contribute to the company’s bottom line.

Instead, in the event of cover-all federal legislation, there should be some focus on business development and promoting innovation. GDPR places restrictions on automation, by giving consumers the right to not be processed solely by automated decision-making, forcing some measure of human influence in profiling decisions. The ramifications are good from a human-interest standpoint, but bad technologically and economically speaking.

There needs to be some balance, because, as Apple CEO Tim Cook argues, technology needs to have the full confidence of consumers in it for it to reach its full potential. As American company Facebook can attest to, no one needs a public-relations disaster revolving around data misuse… even in the rare case where no laws are technically being broken.

Even so, the era in which the legality of a similar situation would be justifiable looks to be drawing to a close. If U.S. companies choose to ignore the signs, they’ll only end up going in the opposite direction on a one-way street. Getting hit by huge fines is no joke, especially if a dead-end is up next. As Groucho argues, nobody would want to work with you if you get labelled as non-compliant. Least of all consumers.

With United Kingdom Prime Minister Theresa May announcing her resignation, the country’s economic future with Brexit looming over its head is as uncertain as ever. Imagine how individual companies are feeling in the aftermath of her decision and ultimate inability to negotiate a deal for Britain’s exit from the European Union.

While uncompromising UK politicians who favor Brexit are generally looking to break up with the EU regardless of the collateral damage, now that a “no-deal” Brexit is back on the table that damage could end up being apocalyptic in scope. The lack of a trade deal with its closest geographical neighbor would be economically disastrous, as UK companies would inevitably be forced to shut down or move, resulting in lost jobs and hard-hit consumers. That’s admittedly the worst-case scenario, but none of the other possibilities were ever all that easier to swallow. Looking back, it didn’t have to be this way.

No Longer Business as Usual in the UK

On June 23, 2016, the same day the UK voted to leave the EU, millions of products streamed along the conveyor belts of pharmaceutical, confectionary, food, and many other Consumer Packaged Goods companies across England, Scotland, Wales, and Northern Ireland. It was business as usual.

Food and confectionary, clad in brightly colored wrappers were being shrink-wrapped and packed into glossy shipping containers and displays. Complex pharmaceutical and other life-science packaging in printed blister-packs similarly streamed off production lines, their labels and package inserts carrying detailed product information.

Companies had based their manufacturing facilities in the UK where they benefited from a highly skilled workforce, access to sophisticated technology, and geographical proximity to the EU. They range from 20 of the largest pharma giants worldwide, which employ some 90,000 people, to massive food and beverage companies such as Unilever, Diageo, and Reckitt Benckiser. From out of the UK, they had been able to ship their products, unimpeded throughout the 28 EU Member States. Then it all changed.

How Brexit Should Adversely Affect UK Companies

The morning of June 24, 2016, these companies’ marketers and production & packaging people awoke to what, for many, was the unexpected and undesired outcome of the Brexit vote. At a macro level, they pondered the impact of the vote on their ability to remain competitive within the EU.

However, as a result of the vote, additional regulation and charges might ensue with the viability of maintaining production in the UK irreparably compromised. Last but certainly not least at a micro level, current labeling packaging will have to change for thousands of SKUs. Who will pay for those changes if not the companies themselves?

Food retailers have already spent thousands of pounds per SKU to comply with 2014 and 2016 EU Food Information Regulations. If those EU-specific regulations are no longer valid, UK companies will have to prepare for the inevitable labeling ramifications. Simply bracing for impact and hoping for minimal financial costs isn’t an option. Physical changes will have to be made.

In terms of medicinal products in the UK, national legislation includes The Human Medicines Regulations 2012. The EU pharmaceutical industry is highly regulated and deals with many facets of the industry, including clinical trials, manufacture, advertising, and labeling. When the UK does eventually leave the EU, uncertainty will stem from the differences between future UK regulations and key parts of EU legislation. Again, pharmaceutical manufacturers, both in the UK and EU, are anticipating label and other printed product revisions and will have to prepare accordingly.

Managing Labeling Changes Post-Brexit with GlobalVision

GlobalVision specializes in automated text, artwork, barcode, and print inspection solutions. With over 25 years’ experience working with leading pharmaceutical, medical device, CPG, advertising, and printing companies and their suppliers, the goal has been to improve the quality of their labeling, packaging, and artwork materials. Doing so helps companies avoid costly errors leading to reprints, production delays, and any resulting client dissatisfaction that could result in financial losses.

GlobalVision solutions meet each of the needs of Regulatory Affairs, marketing, graphics, Quality Assurance and Control, and legal departments, all the way to production. The various tools integrated in GlobalVision desktop and web deployment options are designed to secure companies’ packaging workflows from end-to-end while increasing accuracy, decreasing approval times, speeding up time to market, and streamlining your overall proofreading process.

Over 70% of the world’s major pharmaceutical companies, like Pfizer, have chosen to incorporate GlobalVision solutions into their workflows. Ditto for CPG companies like P&G, J&J, and Nestlé. Major printers like R.R. Donnelley, WestRock, CCL Label, and Clondalkin have followed suit.

Are you contemplating widespread labeling changes post-Brexit? Continue preparing today by learning more about each of our solutions, with applications in every department. Contact us today at [email protected] and ask us to set up an introductory web demo of our solutions, tailored specifically to your firm.

There’s a saying: “Winning isn’t everything; It’s the only thing.” In business however, before you can win, you have to first comply with regulations.

Sure there are get-rich-quick schemes that have earned many a matchstick man a pretty penny. Lasting success, though? That’s earned on the basis of hard work and a solid reputation.

This concept makes regulations the building blocks to any kind of fruitful venture. The rungs in a ladder or the linchpin in a wheel, if you will. The metaphors are especially apt because, when it comes to manufacturing consumable goods, regulations become the guiding force to all aspects of production.

The Key to FDA 21 CFR Part 11 Compliance

If success is built on a solid reputation, then reputation is almost like currency. Waste enough goodwill by taking customers for granted, or worse, for a ride, and you run the risk of having nothing left. That’s why abiding by guidelines is crucial for both your customers and business prospects. The Food and Drug Administration’s (FDA) 21 Code of Federal Regulations (CFR) Part 11 serves as a prime example of the lengths to which one must go to ensure compliance.

The set of guidelines applies to food and beverage companies, drug makers, and medical-device manufacturers among others, all of which are overseen by the FDA. The standards call for the implementation of various controls with regard to the processing of electronic data.

Requirements for the following controls are included:

  • Audits.
  • Audit trails.
  • System validations.

Furthermore, and perhaps most notably, the subject of electronic signatures is covered in great detail. As electronic signatures become more prevalent, their legal weight has grown. They are now recognized throughout most of the United States as being just as binding as handwritten ones, possessing even greater security.

In the Best Interest of Manufacturers

FDA 21 CFR Part 11 effectively smoothed any company’s transition to digital records and electronic signatures at the time of its introduction in the1990s by establishing international standards for each. Today, compliance keeps operational costs down and speeds up time to market, all by minimizing the risk of human error. Following set FDA standards is in the best interest of all parties involved, including the companies themselves who only stand to benefit.

The kinds of companies in question face a bevy of additional regulations. There are countless FDA guidances aimed at current Good Manufacturing Practices so pharmaceutical companies aren’t limited to respecting FDA 21 CFR Part 11.

For further proof, consider labeling and packaging, covered in 21 CFR Part 211. After all, even the smallest typos can have significant repercussions if dosage information is misprinted.

It all goes back to human error and how it must be mitigated, even if only to avoid costly recalls, with the well-being of consumers logically being an even higher priority. What should CEOs be more worried about? How much a recall costs or how much damage a lawsuit can do? The first leads to significant short-term losses. The second leads to irreparable harm to a company’s brand equity and integrity to the point that there may not be even be a long term.

The Real Building Blocks of Success

Systems do exist that both help eliminate the risk of human error and enable FDA 21 CFR Part 11 compliance. For example, the GlobalVision quality control platform, which digitally and efficiently proofs packaging components, has the required technical controls built into the software.

These include:

  • The ability to sign electronically, as mentioned earlier.
  • A hierarchy of access levels, including managers and administrators.
  • Inspection profiles only admins or managers can create or edit.
  • A Login Management module, requiring unique User ID and password combinations.
  • A comprehensive Audit Trail, which logs events, tracing them back to specific users.

It’s critical to note software doesn’t ensure compliance. That is and always will be the responsibility of the manufacturer, but the right tools do make it simpler to get there. Just consider them building blocks in their own right, towards keeping compliant.

 

Of note, the Food and Drug Administration (FDA) has official data integrity guidelines, out in full force as we speak. However, firms who are already following current Good Manufacturing Practices (cGMP) have nothing to worry about.

Of course, the title of the document in question, “Data Integrity and Compliance With Drug CGMP”, serves as clear confirmation to that effect. It also somewhat formalizes cGMP as its own set of guidelines, but it’s best to consider what that acronym stands for before overreacting and realize good manufacturing practices as a concept just makes sense. Meanwhile, data integrity in this instance is simply a byproduct of cGMP, but achieving it is just as critical if not more so in this day and age.

Data Integrity and Security

Take for instance how compliance with the General Data Protection Regulation, or GDPR, is an ever-present item on the task lists of firms in the European Union these days. The security of customer data has become more critical in the internet age and data security and integrity simply go hand in hand.

For the uninitiated, data integrity, as defined in the FDA document, is “the completeness, consistency, and accuracy of data.” To achieve integrity, data should follow the ALCOA mnemonic device by being Attributable, Legible, Contemporaneously recorded, Original, and Accurate. Based on the official set of guidelines, abiding by many if not all of these should be downright logical.

For example:

  • Personnel should be trained to prevent and detect data integrity issues.
  • Each detected quality issue must be handled formally.
  • Only authorized personnel must have necessary access to change records.
  • Each user should have their own, as opposed to shared, log-in credentials.
  • Electronic signatures over handwritten ones are permitted.

The Benefits of Good Manufacturing Practices

So, if these guidelines should already be in place, in conjunction with the proper operating procedures of any self-respecting company, why have them at all?

Well, it’s always better to make standards and regulations official. In an industry like pharma where skirting rules can have severe consequences for consumers, the need is even more prevalent.

In fact, the whole concept of cGMP originated from an inability to get fatal, contaminated tablets off the market in time, before they caused hundreds of injuries/ deaths in 1940. The FDA has multiple tools at its disposal these days to prevent such a disaster from re-occurring: random inspections, official warnings, and drug seizures. Arguably the most effective tool at all though is having the data integrity guidelines in place to start, because they’re preventative instead of reactive.

Keeping Up with the Regulations

Complying with cGMP admittedly means devoting a lot of resources to one’s operations. For example, appropriate quality management systems and procedures must be maintained, only qualified and fully trained employees must be kept on board, and reliable testing facilities and calibrated equipment must be used. What all those pre-requisites have in common is they have come to characterize businesses serious about maintaining some semblance of long-term success.

While the abstract concept of data integrity is far removed from the drugs themselves, there is a direct relationship between it and product quality. Meanwhile, not only is there an indirect relationship between data integrity and product defects, but data integrity and product costs too.

So, in the end, the FDA isn’t asking firms to do anything other than to make life easier on themselves. After all, the “current” in cGMP simply seeks to remind companies that their systems must stay up to date with today’s latest technologies. Any company stuck in the past generally and justifiably gets passed by anyway. The overall goal may be to ensure customers don’t get hurt, but, if companies take the guidelines in stride, neither will they.

Still in its relative infancy as a discipline, regulatory affairs was created to meet a pressing need, regardless of the industry in question.

For example, in pharma, the Biologics Control Act of 1902 was the first legislation to regulate drug quality in the U.S., while American apothecaries date back to colonial times. Of course, medicine as a sheer concept dates back just a couple more years before that… illustrating how much regulatory affairs departments have had to catch up in what can only be considered a short period of time in comparison.

In any case, whether that aforementioned need is in the pharmaceutical (Food and Drug Administration; FDA), energy (Department of Energy; DOE), or financial industry (Securities and Exchange Commission; SEC), the overriding role remains the same. Regulatory affairs officers liaise with those governing bodies and different departments within the company to ensure the rules in every region in which a company’s products and services are distributed are met. Proofreading meanwhile plays a critical role in different facets of a regulatory affairs manager’s day-to-day duties. Digital proofreading enables those responsibilities to get handled as efficiently as possible.

The Responsibilities of Regulatory Affairs

Regulatory affairs responsibilities take the primary form of oversight of a product’s life cycle. Through each of the product’s development stages, there are strict rules and guidelines to follow to ensure compliance. Proofing figures in at several of these steps:

  • Initial rule/ law changes are lobbied at the state and federal levels.
  • Product/ drug applications are submitted to regulatory bodies.
  • Briefing documents are compiled for the appropriate regulatory agency to review.
  • Packaging copy created by marketing is sent for internal and external approval.
  • Packaging and labeling updates are evaluated.
  • Changes are applied across different product lines whenever necessary.
  • Info is revised (like the drug formulation and dosage in pharma) to extend product life cycles.

In each case, the regulatory affairs department enters into or even drives the file-creation process. it is imperative the text and artwork be 100% accurate from a spelling standpoint and based on what had been approved internally. While this can be accomplished through manual proofreading, i.e., with the naked eye, digital systems have been proven to catch more errors early in the process, cut down on revision cycles, and improve overall efficiency.

Customer Safety and Post-Marketing Compliance

As an offshoot of the aforementioned tasks, the responsibility for getting products to market as fast as possible also falls on the shoulders of regulatory affairs associates and offices. Regulatory and compliance managers and coordinators must ensure products meet all requirements and that the tests to that effect have gone smoothly. Digital proofing solutions lend a helping hand in that regard.

Furthermore, regulatory affairs departments are generally in charge of post-marketing compliance. If safety issues arise after a product has gone to market, regulatory affairs coordinates with the appropriate agencies to issue a recall if necessary. Recalls can relate to possible contamination or issues with the manufacturing process or, yes, even the packaging.

From a packaging standpoint, digital proofing serves as a cover-all by ensuring even the smallest issues like missing or misplaced decimal points in dosage figures get printed properly. In an industry like pharma, such an error could prove to be disastrous and, in a worst-case scenario, lead to consumers taking fatal doses.

There’s only a risk of that happening if the packaging makes it to production. The importance of regulatory affairs departments thus becomes clear, as does the need for a digital proofing solution therein.

A name on a dotted line may technically hold just as much legal weight as ever, but in the era of electronic signatures a contract can be enforced without a pen ever touching paper.

What Are Electronic Signatures?

Indeed, electronic signatures, where an “electronic sound, symbol, or process” is used to sign and show intent to sign a record, are becoming increasingly common and for good reason. You may have run into examples of electronic signatures already, maybe without realizing it. Here are a few:

  • Physical, electronic signatures created with a stylus
  • Options to sign that have been selected in e-signature software
  • Usernames entered in (upon a request for consent), accompanied by their passwords
  • Various forms of biometric data

They’re each arguably more convenient than their physical counterparts (based on the ability to sign documents remotely), while the environmental benefits are obvious. Reducing the reliance on paper records to the point that they may become obsolete obviously reduces the carbon footprint of companies making the switch.

Overhead costs drop as a result too, making electronic signatures cost-effective in addition to simply being the next stop at which an increasing number of businesses are getting off. It may be time to join in or risk watching the world pass you by from out the passenger window.

Digital vs. Electronic Signatures

There can be some confusion over the difference between digital and electronic signatures. To be clear, they aren’t the same thing. Electronic signatures are electronic versions of what one would consider a hard-copy signature used to confirm consent.

Digital signatures are similar, but take the extra step of verifying the identity of the person doing the signing. In that sense, one could argue all digital signatures are electronic signatures, but not vice versa, kind of like how a thumb is a digit on the hand, but not all fingers are thumbs.

So, why are electronic signatures all the rage and digital ones aren’t? Based on the Uniform Electronic Transactions Act and Electronic Signatures in Global and National Commerce Act the two are equal in terms of legal significance. Remember, individual businesses can always go the extra mile and require digital signatures and they’d still be considered electronic as well. They don’t have to, though. In other words, why run a marathon when everyone just cares about the 100m dash?

Are E-Signatures Legal?

Rest assured, electronic signatures, even if they’re not digital, are legally bindingWith partial exception to in California, electronic signatures are enforceable throughout the country just as if they were handwritten signatures. After all, there’s little reason to doubt the security of an electronic signature. They’re actually more secure than a physical signature.

Look at it this way: What makes a physical copy of a contract so secure? “Secure” in that context usually implies it’s safely under lock and key in a file cabinet somewhere. That doesn’t make documents invincible by any stretch. Pieces of paper can easily fall victim to random acts of God or crime… or a simple accidental rip.

In fact, it just seems second nature to back up a contract by scanning it in and keeping a digital copy. And how far removed is that from embracing e-signatures, really? Pretty far, in the sense that a document with a digital signature becomes effectively tamper-proof. In terms of record-keeping, administrators are given greater control through the use of electronic signatures, which also lead to enhanced traceability via an audit trail, for example.

If the authenticity of a physical signature ever comes into question, there is only so much you can do to prove it’s real. You can go much deeper with digital signatures, which can provide a data trail directly inside.

In a data-driven society, electronic signatures aren’t just a fad, but instead, represent a single example of an ongoing societal trend of improving on set standards. They’re also setting new ones.

Despite political hurdles and an economic recession, Brazil is forecasted to move up in the pharmaceutical world. The Latin American behemoth was ranked as the world’s 10th largest pharmaceutical market in 2011 and is predicted to take the fifth spot by 2021. In addition, Brazil’s pharmaceutical market is estimated to grow to $29.9 billion by 2021. How can Brazil achieve this? There are a few key factors at work here.

A Growing Demand for Healthcare

A change in demographics seems to be a key element in this financial turnaround. Brazil has an aging population, increasing the need for healthcare. There are cities that have expanded their population to the point where they would now be able to contribute more to the growth of the economy. These citizens are making more money, increasing their purchasing power and demand for better healthcare services. As it turns out, the public is willing to pay for it.

According to McKinsey & Company, “midsized cities (20,000 to 500,000 people) will be responsible for more than 50 percent of total consumption growth in Brazil.” About fifty percent of citizens living in these cities say they are willing to spend more on healthcare. This will increase the demand for a pharmaceutical market… and one that will last.

Storage and Transportation Efficiency

In the past, Brazil’s infrastructure was poorly designed and was infested with bureaucratic control. It has since made improvements, especially to Rio de Janeiro International Airport, which has tripled its cold-storage capacity, making it easier for the country to store pharmaceutical products with proper insulation.

In addition, it has been recognized by the International Air Transport Association and was awarded their Center of Excellence for Independent Validators (CEIV) Pharma certificate. It has proven to be a good investment for Brazil, as temperature-controlled pharmaceuticals make up about a quarter of the cargo’s revenue.

FedEx, DHL, and UPS have also expanded their services in Brazil and now have the capability to transport temperature-controlled drugs and medicines. According to Pharma Logistics IQ, Brazil has acquired about 300 trucks that will cover the Rio de Janeiro region as well as the state of Goias and its surrounding areas.

A Wealth of Opportunities

Another reason Brazil is predicted to move up in the pharmaceutical world is the growth of opportunities. Many pharmaceutical companies see the expansion of the market because of the availabilities of active ingredients that have been brought into the nation. Brazil has been relying on imports from other countries, like the United States, who provide them with raw materials. This is because of a partnership with the World Health Organization and the United States Department of Health.

The Butantan Institute in Brazil partnered with these organizations to produce the Zika vaccine. In 2015, the virus-carried by mosquitos-ravaged Brazil, causing birth defects in newborns. The institute was granted this opportunity in 2016 because of the production of new biopharmaceuticals. This is a huge accomplishment for Brazil, as it will be able to protect its citizens as well as any visitors from the potentially fatal disease. According to Jorge Kalil, director of Butantan, this break will allow the institute to “contribut[e] to the advancement of scientific research in the country.” However, the after-effects of the economic crisis are still an issue to not only Brazil but to its pharmaceutical market as well.

Rise Just to Fall… Again?

With big responsibilities can come big problems and Brazil is no exception. Every year the Agência Nacional de Vigilância Sanitária (ANVISA) sets a maximum price increase that drug makers must follow. According to Pharma Logistics IQ, 90% of active ingredients are imported to Brazil, and the country’s tax code is very restrictive. Thanks to these two factors combined, drugs become very expensive to manufacture in Brazil.

Edwin Dominguez, a GlobalVision sales representative who does business in Brazil, shares the same sentiment. He says that imports have become increasingly expensive.

“It is a very protective market for goods coming from anywhere outside of the Mercosur trade bloc [whose members include Argentina, Brazil, Paraguay, and Uruguay], which makes raw material an expensive part of the final product for the consumer, “ he says.

This, in turn, slows down the production of its drug-making process. Although the government has implemented initiatives to promote local drug production in Brazil, it remains to be seen if the country will be able to overcome this financial hurdle.

Politically-Charged Economy

“Political climate on Brazil is very unstable right now,” says Dominguez. He feels that the damage has already been done and “corruption cases are overwhelming in Brazil.”

The scandalous and corrupt government led by President Michel Temer, who was charged in June 2017 with accepting bribes, has made it difficult for the pharmaceutical industry to make headway in Brazil. This, combined with already tough economic times, has proven to be a challenge for Brazil.

Brazilians will go to the polls in October 2018 and it is unknown how this will affect the pharmaceutical industry. There are so many opportunities for Brazil, but the past might hold the market back.

Conclusion

Predictions surrounding Brazil’s pharmaceutical market are logically optimistic, pending certain factors of course. However, these are numbers that can change at any time because of the notoriously unstable environment in question.

The country has come far regarding biopharmaceutical advancement and infrastructure, something that most Brazilians would have never thought was possible. They have been given a chance to help their aging population and those who have been affected by deadly diseases. Now that small to mid-sized cities are contributing to consumer growth, there is an increase in demand for healthcare. It appears that the South American giant has a lot of potential, but can it move forward beyond the past that haunts it?

With the constant increase in manufacturing prices for drug makers combined with the political pitfalls, there is no telling what the future of Brazil’s pharmaceutical market will look like. If it can overcome the financial and political adversity, nothing stands in the nation’s way of becoming the next capital of the pharmaceutical market.

What is the FDA?

The Food and Drug Administration is a government agency that operates under the United States Department of Health and Human Services. The FDA is responsible for protecting and ensuring public health in relation to drug and food products. Additionally, they monitor the labeling and advertising of products that are sold in the United States. Whether the products are produced domestically or from foreign countries, the FDA assures that the labels on the products are factual and compliant. Also, The Federal Food, Drug and Cosmetic Act is under the FDA’s authority as well as the Fair Packaging and Labelling Act.

The products that are FDA approved range from human and veterinary drugs, to biological products, to medical devices and the United States’ food supply. The agency monitors bottled water, but not any alcohol products. The Department of the Treasury’s Alcohol and Tobacco Tax and Trade Bureau deals with all alcohol goods. The FDA is also responsible for regulating, the manufacturing and the marketing of other substances like tobacco. Moving away from the drug and food industry, the FDA also regulates cosmetics and pesticides. They keep up with trends and recalls on the food and pharmaceutical markets to keep the public informed.

The FDA gives their stamp of approval to companies that they have reviewed and conclude that the benefits of these products outweigh the risk of the public’s health. The FDA will deem these goods to be safe for consumers and will not cause bodily harm.

And the CFR? What is that?

Most of us in the packaging and labelling industry are familiar with the FDA and maybe what they do as a government agency, but what exactly is the FDA 21 CFR? Firstly, the Code of Federal Regulations (CFR) is a code that the U.S. Federal Government uses for general and permanent rules. By general, I mean that they edit the volumes periodically. They are created by the Federal Register by the executive departments. The titles of each CFR represent the different types of products that are reviewed by the FDA. The CFR 21 is titled as the Food and Drug Administration. There have been multiple volumes released of the Title 21 over the years, as each volume is revised every calendar year. The current and previous versions of the CFR 21 and other titles can be accessed in the E-CFR.

For anyone that hasn’t accessed the E-CFR before, Title 21 has been broken up into parts that also has links, so they can be viewed individually. In Chapter one, you will find all the information about labeling and packaging for food and drugs. For example, you can read about nutritional quality guidelines and current good practices by FDA approved companies. For any drug or food business that is looking to become FDA approved, this would be a good resource to use for researching.

What about FDA Compliance?

To maintain and ensure the safety of public health, the FDA has policies in place for FDA approved companies to remain compliant. The Compliance Program Guidance Manual (CPGM), gives instructions to those working for the FDA to evaluate businesses that are under the Federal Food, Drug, and Cosmetic Act. According to FDA, this document is available to the public under the Freedom of Information Act. All of the programs in this manual are divided into sections. For example, if you choose to view the Drug Compliance Program, there are subsections that describe how inspections are done and the what to look for during labelling reviews. They even have a subsection that discusses “Drug Repackers and Relabelers.” Any company or person can click on the links in this section to understand how the FDA conducts their compliance evaluations. The Food and Cosmetics Program is similar to the drug program, having different subsections for more specific information about compliance and inspections.

GlobalVision and the FDA

Did you know that GlobalVision works with many products that are FDA approved? Corporations such as Abbott Laboratories, Proctor & Gamble, Pfizer and WestRock all trust GlobalVision to make sure that their labels and packaging are error-free when they hit the market. Whether it’s the software or the hardware, GlobalVision has been able to help many companies in the pharmaceutical and food industries with their proofreading process. GlobalVision can help food, drug and cosmetic companies to remain compliant and hopefully take them on the road to be FDA approved.


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How can you define product quality? This term can be interpreted in different ways depending on the country or region you live in, but perhaps the most crucial variable that determines what quality represents is the unique set of quality objectives integrated by a company.

In a nutshell, quality refers to all actions taken to meet consumers’ expectations; therefore, a quality management system (QMS) refers to the compilation of processes that such companies use to maintain customer satisfaction by implementing quality objectives and quality policies. When a company establishes a matured QMS, an intricate network of resources, procedures, and policies is set to guide them towards one simple goal: deliver the very best version of their product.

Quality management systems have such an essential role in today’s marketplace that no modern company is likely to survive without one. They integrate several internal policies that eventually provide the company with a process approach to project execution. Simply put, it enables businesses to identify, control, measure, and improve what they do to boost their performance.

What the ISO 9001:2008 Standard Represents

One way companies can ensure high-quality standards is by demonstrating to accredited organizations that they can fulfill specific QMS requirements. Founded in 1947, the International Organization for Standardization (ISO) is in charge of promoting and setting worldwide guidelines for propriety, commercial, and industrial standards.

Currently working with over 160 countries, ISO has become the world’s largest promoter of international standards and a reference in almost every sector of the manufacturing industry.

Created in 1994, the ISO 9000 family is a series of QMS standards designed to help companies meet both customers and stakeholders’ needs while at the same time meeting specific product statutory and regulatory requirements. Specifically, ISO 9000 lays down the fundamentals for every QMS, including the seven fundamental quality principles upon which the whole family is based. However, only the ISO 9001 exposes the requirements that companies wishing to fulfill the standard must meet.

The 2008 update made to the ISO 9001 standard, commonly referred to as ISO 9001:2008, outlines the main modern quality management principles and requirements companies’ must meet to emphasize customer satisfaction, including business motivation and continual improvement. Using ISO 9001:2008, companies focus on providing high-quality services and products to their customers and with over 1 million certifications worldwide, it is currently one of the most broadly used QMS tools available.

The first step to becoming ISO 9001:2008 certified involves initial assessments of the company’s quality system, defining the areas that comply and those in which improvements need to be made. Once that’s been resolved, and everything has been set by the standard, a certification body will then conduct a number of audits to ensure conformance with the requirements. If approved, the company then have to subject to a three-year surveillance cycle. As you can see, the certification process can take as long as over a year, yet any company that understands its value knows it is worth enduring this process.

Don’t be Afraid of Internal Audits

Internal audits can be a real nightmare for most companies; however, they’re essential in order to truly examine how quality management systems perform. Because of this, they are also a considerable part of the ISO 9001:2008 certification process. While some may be reluctant to them, it’s important to keep in mind not only what they can provide to your business, but what it says about it if you avoid them. A few benefits of internal QMS audits include:

  • Increase in your business’ revenue
  • Valuable feedback that strengthens your QMS
  • Promotion of a positive company culture
  • Greater product quality
  • Better communication and consistency of your company’s processes
  • Boost in workplace morale
  • Increase your reputation as a company
  • Achieve international quality recognition

Why Businesses Opt for ISO 9001:2008 Certified Companies?

Imagine you’re choosing a new supplier. You will likely look for someone with the following traits:

  1. Delivers results consistently
  2. Possess great problem-solving abilities
  3. Provides a significant return on investment (ROI)

Companies that become ISO 9001:2008 certified already have voluntarily proven all these traits by actively being held accountable for the quality of their processes and operations. The certification also tells future clients they can expect the same high-quality results each and every time. To expand on this, here are the main benefits of working with an ISO 9001:2008 certified company:

Consistency

ISO 9001:2008 certified companies ensure a consistent workflow process every time you choose to work with them. You can even evaluate this by taking a look at the low variation rates these companies offer, which directly translates to product and ordering consistency.

Fast Problem Resolution

Be sure that if any problem arises while collaborating with an ISO 9001: 2008 certified company, the policies and processes integrated into their QMS will quickly enable a fast resolution of the issue. But the ISO standard doesn’t end with that, it also makes sure the QMS includes a way of collecting and analyzing customer feedback and initiating effective corrective actions. Rather than waiting months for a resolution, an ISO 9001:2008 certified company would already have procedures in place to manage any potential problem that may arise.

Meeting Customers’ Expectations

As we stated before, this is the primary focus of the ISO 9001 standards. Certified companies will know the importance of adopting a QMS that ensures continued quality through the application of preventative measures. When implemented correctly, a good QMS is able to ensure every customer is satisfied while also complying with any regulatory requirements.

Maintaining Certification

An ISO certification is not a lifetime membership. Each ISO 9001:2008 certified company is regularly audited to ensure their compliance with the QMS standards. This ongoing process of continued scrutiny actually increases their effectiveness and helps improve final product quality, making these companies an incredible option to work with.

Continual Improvement

By assuring regular audits, the ISO 9001:2008 standard also guarantees that companies evolve and find new ways of addressing different types of issues in order to improve over time. Continual improvement means that all processes must be run efficiently, all policies must be monitored continually, and results must always get better and better.

Conclusion

The ISO 9001:2008 Certification is only given to businesses capable of proving efficient management systems, therefore, companies who work hard on achieving this certification show prospective clients that all of their services and products meet and exceed the highest level of international standards. To run a business in today’s world not only means that you have to deal with a high degree of competition, but also with sky-high customer demands. That’s why complying with ISO 9001 standards has become such a huge advantage right now it can actually make or break the future of your company.

GlobalVision can proudly say it belongs in this group of organizations that offers products specifically built to endure the highest quality standards. We implement and maintain ISO guidelines as a testament to our commitment to our customers and the quality in which we develop all of our systems. Because our main line of business is to provide quality control services for others, we take our own product’s quality very seriously, that’s why our final goal is to assure our clients we keep their specified requirements in mind at all times.


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