What Is The Best Way To Keep Up With Changes In FDA Standards?

Posted by Anelis Aurand-Araos

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stockvault-book-pages128050This is an interesting concept, one that actually goes by the name of “Regulatory Intelligence.”  Regulatory Intelligence (RI) is something that's really important because the standards are always evolving. In the United States, for example, they start at the top with the Federal Food Drug & Cosmetic Act, and recently, the Drug Quality and Security Act of 2013. FDA takes these laws and promulgates regulations and guidance documents to interpret those regulations.

Changes to regulations and other notices are published daily in the Federal Register, which can be accessed publicly on regulations.gov. Hundreds of notices could be published daily. Now, you're not going to have a person on your team looking at regulations.gov every day evaluating what's been updated on the Federal Register. That's just not good use of your time and things are constantly changing. Let's explore some effective ways in keeping your company up-to-date.

Stay In The Loop By Becoming A Member of Key Trade Associations and Groups

stockvault-laptop-work113049One of the ways we like to stay on top of everything is with memberships in trade associations and trade groups, including: The Pharma & Biopharma Outsourcing Association, or PBOA, the Consumer Healthcare Products Association or CHPA, the Natural Products Association or NPA, Pharmaceutical Research and Manufacturers of America or PhRMA, and others.

Those are great resources because there are meetings where you can network, webinars you can attend, and they send out emails alerting you of new guidances which specifically apply to you to pay attention to. Day to day, you can get FDA RSS feeds and news bulletins.

The Small Business and Industry Assistance, SBIA program, is a great resource constantly sending out new guidance or information about webinars explaining FDA's current thinking on different topics. FDANews is a private group, who also sends daily bulletins. These are all free of charge. If you want more detailed or "insider" information, you can pay for subscriptions to business intelligence publications.

For example, the Pink Sheet is for prescription products and regulatory updates. The Tan Sheet provides in-depth news and analysis of the nonprescription pharmaceutical and dietary supplement industries. The Gold Sheet provides insightful analysis to help you comply with U.S. and international pharmaceutical manufacturing QA/QC requirements.

Using Pharmaceutical Organizations and Resources Are Beneficial To Your Regulatory Intelligence Program

Determining-Best-Manufacturing-Processes-Guide-For-Pharmaceutical-Products Lastly, there are professional organizations that are of great benefit for members, such as the Regulatory Affairs Professional Society or (RAPS) or the American Society for Quality (ASQ). All of these resources contribute to a well-balanced RI program. In a specific example where RI was useful, there was recent guidance on what can be reported in an annual report so you're not submitting so many CBEs and CBE30s to the agency. We had to go back and look at our change control SOP (Standard Operating Procedure), and when we're evaluating the risk of a change we can refer to the guidance to aid in the decision of submitting a CBE or keeping it to an annual report. How did we hear about this new guidance? We were notified of the new guidance from an email from SBIA. We also received it from RAPS, CHPA and The Tan Sheet. That's one example of how staying on top of things can help your processes. Going forward, instead of putting together an entire CBE submission, which is time consuming and potentially costly, we can simply file it in an annual report (when appropriate).

To conclude, staying on top of changes with regulatory standards is definitely something that needs to be done and is definitely something we do. Having a robust regulatory intelligence program is essential for keeping up with changes in FDA standards.

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Topics: Quality & Regulatory

Anelis is the Director of Scientific Affairs and Chief Compliance Officer at WellSpring, and has over ten years of pharmaceutical industry experience in Regulatory Affairs, Quality, and Scientific roles. At the University of Florida, Anelis earned her Bachelor of Science in Chemistry, as well as Master of Science in Pharmaceutical Outcomes and Drug Regulatory Affairs. She also earned a Master of Science in Analytical Chemistry at Southern Connecticut State University. In her role at WellSpring Pharmaceutical, Anelis is responsible for the overall corporate quality, compliance, scientific & regulatory affairs direction and strategic guidance for the US and Canadian businesses.

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