Pharmaceutical Labeling. Managing Regulations and Requirements for Pharmaceutical Labeling

Transcription

1 Pharmaceutical Labeling Managing Regulations and Requirements for Pharmaceutical Labeling

2 Table of Contents 1. Don't Understate Dangers of Counterfeit Pharmaceuticals 2. DSCSA is in effect, and supply chains must keep up 3. Need Help Implementing & Maintaining a Validated and Compliant Labeling Solution? 4. Make your Labeling Count

3 Don't Understate Dangers of Counterfeit Pharmaceuticals

4 Most of the time, when you buy a counterfeit consumer product, you'll be annoyed. The quality of the materials and the performance likely won't be up to the standards that you expect. You'll probably want your money back, and you might demand answers from the retailer that sold the product to you. But most counterfeit consumer products won't affect your health the way that counterfeit pharmaceutical drugs might. The makers of fake drugs aren't just depriving legitimate manufacturers of revenue they're also harming people. Mark Davison, Principal Consultant & CEO at Blue Sphere Health, recently told Pharmaceutica Processing that counterfeit drugs can be more of a problem than many assume. These aren't like generic medicines, which are legal, regulated and must be as effective as brand-name medications. Counterfeiters deliberately attempt to deceive consumers by passing off medications that, in some cases, can be significantly different from the original product. On top of that, they may not even be properly sterilized. Davison argues that many legitimate manufacturers have been slow to recognize the threat that counterfeiting poses to their product lines. "Don't assume that your products are immune," he told the news source. The U.S. Food and Drug Administration (FDA) has sought to stem the tide of counterfeiting through the use of the Drug Supply Chain Security Act (DSCSA),

5 which created a nationwide "track and trace" system when it was enacted in Drug manufacturers seeking to comply must label their products with unique serial numbers. It can be difficult for manufacturers to keep up with changing federal regulations, but preventing drug counterfeiting is worth the effort. Enterprise Labeling Solutions can help drug makers keep their labels in compliance on a large scale, with greater efficiency. To find out more about Pharmaceutical Labeling and meeting all of your regulatory challenges, check out our webinar on labeling best practices with customer, Ferring Pharmaceuticals.

6 DSCSA is in effect, and supply chains must keep up

7 Given the great risk if anything goes wrong, every element of the pharmaceutical supply chain must be held to extremely high standards. If your company is affected by the Food and Drug Administration's Drug Supply Chain Security Act, which is Title II of the Drug Quality and Security Act, failure to catch up with the relevant regulations may result in damaging fines and other legal action. Still Rolling Out One factor to keep in mind about the DSCSA is that it is not a one-and-done implementation. Its first few provisions came into effect in 2014 and 2015, but baked into the law is a roll-out process that will last through In that time, the FDA plans to work with businesses such as manufacturers, distributors, wholesalers, repackagers and dispensers to add more provisions. Unique product identification, tracing, and verification top the FDA's list of what's to come. Supply chain transparency at all levels is the endgame. The agency hopes that in the future, it will be easier to determine immediately whether drug products are real and counterfeit. Recalls will also become more precise and efficient. Current Provisions Since 2015, several elements of the DSCSA have been in effect. Product tracing at the lot level has been required since January 1, 2015, all in line with FDA standards. Since then, a trading partner authorization requirement has also applied. This means every part of the supply chain must have approval from

8 the appropriate bodies. Working with Labels Barcode labels and the related software are essential for companies making their products trackable up to FDA standards. As laws evolve over the next seven years, there will inevitably be more changes required of manufacturers, distributors and pharmacies. And if their labeling systems are flexible and comprehensive, they will respond to these rolling modifications with ease. For more on pharmaceutical labeling check our Pharmaceutical Labeling resources - "7 Ways to Stay Compliant, Stay Competitive with Enterprise Labeling."

9 Need Help Implementing & Maintaining a Validated and Compliant Labeling Solution? Look no further - Loftware offers a comprehensive enterprise solution that meets the needs of medical device and pharmaceutical manufacturers. Loftware recently announced that they have partnered with USDM Life Sciences, a leading global regulatory consulting firm in the life sciences industry, to deliver the new Loftware Validation Accelerator Pack (VAP). The Loftware VAP enables customers to quickly and cost-effectively implement and maintain a validated and compliant labeling solution. This new solution which simplifies compliance, increases productivity and minimizes validation costs, complements Loftware Spectrum, the industry s most

10 powerful labeling solution designed to address the unique complexities and regulatory requirements of labeling in the pharmaceutical and medical device space. The Loftware VAP, which enables Loftware s medical device customers to validate Loftware Spectrum to meet FDA and EU regulatory requirements, provides a standardized approach for ongoing validation. The Loftware VAP paired with Loftware Spectrum s configurable workflow framework and esignature capabilities provides a jump-start towards validation and helps to facilitate 21 CFR Part 11, underscoring Loftware s ongoing commitment to medical device and pharmaceutical labeling. USDM s VAPs have proven to help companies meet the requirements of the FDA and other Regulatory Agency validation requirements for computer systems and equipment supporting regulated functions. The UDI Final Rule certainly resulted in medical device companies updating or implementing new systems and equipment that require validation, stated Jay Crowley, Vice President of UDI Services and Solutions at USDM Life Sciences. The Loftware Validation Accelerator Pack (VAP) helps these companies meet compliance requirements while reducing validation time and costs by up to 50%, achieving better efficiency and a competitive edge. Loftware and USDM developed the Loftware VAP to be comprehensive and include key components for validation and compliance in the medical device field. The package is a complete set of content rich validation templates that are ready to be configured to reflect each customer s configuration decisions. Our partnership with USDM is a perfect complement to Loftware Spectrum which provides unrivaled capabilities for meeting the complexities of labeling in highly regulated industries, stated Josh Roffman, Vice President Product Management at Loftware. With the Loftware VAP, we re able to further accelerate and streamline the validation process, providing an integrated and comprehensive labeling solution that simplifies compliance, increases productivity and minimizes validation costs, he added. For more on Pharmaceutical Labeling, check out our Q&A report on the topic.

11 Make your Labeling Count For more information how you can meet all of your Pharmaceutical Labeling needs, contact Loftware today. BOOK A CONSULTATION