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Ensure Your Labels Meet all FDA Drug Labeling Requirements with Automated Quality Control

Date: November, 2022 | CategoryQuality Author: Hana Trokic


For highly regulated industries like pharmaceuticals, following FDA drug labeling requirements is one of the most crucial aspects of the product lifecycle. With so many laws, rules, and regulations to follow, the task of creating documentation, labels, and content surrounding a single drug or product quickly becomes stressful and tedious.  

Yet, drug label requirements are in place for a reason – and a good one at that. The accuracy of drug labels ensures that patients and consumers are being given proper instructions and dosages of a prescribed drug. Label accuracy also ensures that pharmaceutical companies avoid life-threatening side effects for their consumers, large recalls, and colossal financial downfalls.

With so much on the line, pharmaceutical companies cannot risk label errors slipping through.    

Thankfully, software shortcuts such as automated quality control is a one-stop shop for your compliance needs that makes sure your labels meet any and all FDA drug labeling requirements. 

Automated quality control is an easy solution that allows you to proofread labels and content in record time. Not only does it decrease proofreading and review times, but it also decreases errors while increasing the efficiency of your workflows. 

With this comprehensive software solution, you can ensure that all of your labels follow FDA requirements while being accurate and completely error-free.    

The Highly Regulated Pharmaceutical Industry 

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When it comes to drug labeling, the FDA’s primary purpose and concern are to ensure patient safety and provide healthcare professionals with information about the drug and how it should be prescribed. Some of the
FDA’s drug label requirements include

  • Highlights (a concise summary of label information)
  • Full prescribing information
  • Recent Major Changes 
  • Indications and Usage 
  • Dosage & Administration 
  • Dosage Forms & Strengths 
  • Contraindications 
  • Warnings & Precautions 
  • Adverse Reactions (listing of most common adverse reactions) 
  • Drug Interactions 

With so many regulations to follow, it’s no surprise that such heavy importance is placed on label accuracy. Even so, it is estimated that over 50% of medication use errors are associated with poor drug labeling. Though this includes patient misunderstandings, it is generally believed that implementing standardizations such as text, language, typography, and other display standards will drastically reduce errors in drug labels. 

Along with patient safety, it is also important to note that labeling errors lead to significant recalls and financial losses, which are more frequent than you would think. Clinically important drug recalls occur approximately once per month in the United States. For perspective on just how significant these financial impacts can be, Johnson and Johnson lost roughly $600 million in sales after closing a distribution site due to a recall.

To avoid the detrimental consequences that label errors bring, pharmaceutical companies need to implement a functioning proofreading and reviewing process. They must inspect labels, artwork, and content at every step of production, ensuring the accuracy of the complete file. 

Innovations in automation, such as GlobalVision’s file comparison software, allow pharmaceutical companies to implement an all-in-one quality control platform that inspects complete files, including text, spelling, artwork, graphics, braille, and barcodes, at every stage of production. It allows for label standardization as it detects discrepancies no matter how small, making it easier for companies to ensure their labels are following the standards set in place.

Through automated quality control, companies can be sure that their labels are consistently accurate, and meet all standards and compliance guidelines, while meeting FDA drug labeling requirements with increased ease and efficiency. 

The Benefits of Automated Quality Control 

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Many large global pharmaceutical companies have yet to implement new technologies that increase workflow efficiency. 

In some cases, many still rely on manual and labor-intensive proofreading and reviewing processes prone to mistakes, leaving huge potential for operations to be optimized and streamlined for maximum efficiency. 

The solution, thankfully, is simple. Automated quality control inspects content and artwork with complete ease, lightning speed, and increased accuracy.  

To keep up with increasing global consumer demands, pharmaceutical companies are creating almost immeasurable amounts of products, each with its own packaging, labeling, and documentation. This content must be meticulously reviewed and proofread to ensure that the final product is error-free. 

Manually proofreading this amount of content is not an efficient solution for companies that need to keep up with growing demands. Automated proofreading software offers a foolproof solution to ensure all this generated content is checked and proofread perfectly. 

This advancement in proofreading processes eliminates the need for manual document inspections and leaves it up to technology. The software conducts digital checks for discrepancies in text, spelling, graphics, color, and more. The software conducts thorough inspections in a fraction of the time and ensures that labels and content are 100% accurate before going out to the hands of patients and consumers. 

This technological advancement ultimately increases productivity and workflow efficiency and offers endless benefits unmatched by manual inspections. Not only does automated proofreading software help ease the proofreading process, it simply makes proofreading better. 

Keep Up with FDA Drug Labeling Requirements 

Spell Check imageIf you want to keep up with FDA drug labeling requirements with complete ease, switch to automated quality control. A trusted technology, GlobalVision’s innovative automated solutions have been solving problems for pharmaceutical companies globally for over thirty years.  

By using GlobalVision to eliminate time-consuming and inaccurate manual checks, the largest pharma companies worldwide cut review times by 89%. Just by making the simple switch to automated quality control, top companies got critical healthcare products into the hands of consumers faster and with complete confidence that their labels and content are 100% accurate and FDA compliant.

To name only a few, GlobalVision has helped:

Ensuring that you meet all FDA drug labeling requirements is far from easy. Yet, through the simple introduction of automated quality control, companies can rest assured that they are drastically eliminating the risk of human error, getting their product to market faster with fewer revision cycles, and reducing the risk of costly recalls and misprints. 

Ensure Consistent Quality 

With endless benefits and countless advantages to your company’s revision processes, automated quality control is the leading solution for pharmaceutical companies that wish to ensure the quality of their labels and content. All the while ensuring they meet all FDA labeling requirements. 

Enhance your proofreading practices and make the switch today. See how automated quality control can streamline your business’s workflows by allowing you to proofread critical content at scale while maintaining the complete accuracy of your labels and content.   

Discover firsthand the benefits of automated quality control. Request a demo of GlobalVision, and get started today