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Patrick Stone

FDA Compliance

The FDA’s Action Plan Demands Some Industry Action, Too

It may take years to iron out some wrinkles, but it’ll be worth it

Published: Monday, May 4, 2015 - 12:13

The U.S. Food and Drug Administration (FDA) has a “Plain Jane” version of its Pharmaceuticals FY 2015 Action Plan. In this article, however, let’s look at some interesting wrinkles not necessarily contained in the document.

This “Plain Jane” action plan, taken straight from the document, reads as follows:

“The following Pharmaceuticals FY 2015 Action Plan (the Action Plan), developed by the Office of Regulatory Affairs (ORA), the Center for Drug Evaluation and Research (CDER), and the Center for Veterinary Medicine (CVM), is intended to facilitate operational and program alignment as FDA transitions to distinct commodity-based and vertically-integrated regulatory programs with well-defined leads, coherent policy and strategy development, and well-designed and coordinated implementation.”

Interesting wrinkles

The Pharmaceuticals Inspectorate will change the way FDA inspectors conduct audits and the number of audits conducted in a years’ time. There are some interesting things to note here:
1. The Center for Biologics (CBER) is noticeably not included in this reorganization effort.
2. District offices will not be at the helm when it comes to which drug firms get inspected and how compliance for Official Action Indicated (OAI) cases and Voluntary Action Indicated (VAI) cases are handled.
3. The CDER will be assuming the lead role and Center compliance teams will be responsible for industry corrective action plans.

Traditionally, the district compliance team for the drug company took the lead role in compliance strategy and remediation. But now, the inspectors conducting drug audits will be dedicated and certified to conduct inspections. This will reduce errors and enhance the quality of inspections domestically and internationally. This will also increase the number of observations (483 notice of observations), warning letters, and consent decrees.

When a generalist inspector conducts a drug audit, he or she may miss a systemwide failure or process control deviation due to a lack of training. By contrast, when a professional team of inspectors with dedicated training for a drug firm’s system conduct an audit, those same compliance issues are not usually missed. This is a positive step in the right direction, however, building the new drug teams and training them accordingly will take years.

Quality by design implementation is looming, so this will also affect the training requirements from a system-based approach to a quality-by-design approach.

Don’t be caught off guard by this new way of doing things. The FDA is making some changes, and regulated firms need to make sure they understand them.

First published Apr. 23, 2015, on the AssurX blog.


About The Author

Patrick Stone’s picture

Patrick Stone

Patrick Stone works toward a future where disease cures and prevention are the main goal of all new test articles. Stone is president and lead consultant at TradeStone QA LLC, which serves the global public by protecting the supply and quality of healthcare products before entering the market place. Stone specializes in Institutional Review Board (IRB) compliance and quality assurance audits; computer system validation and 21 CFR Part 11 compliance; LIMS/data management system compliance; and 21 CFR, GCP, cGMP, and ICH compliance. Stone is the author of Bubble Gum Badge—An FDA His-Story (Xlibris Corp., 2011). You can follow Stone on Twitter.