Reader Rants To Rob On Regs

By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL

I recently got an email from a reader about the stage 3 requirements for the new FDA guidelines on validation of pharmaceutical manufacturing processes. I thought I would go to the guidance to learn more about stage 3. After reading the definition for pharmaceutical validation, I scrolled through the document reading about pharmaceutical validation classifications, types of validation, validation phases, and various means of qualification. Apparently, stage 3 in process validation is “The continual assurance that the process remains in a state of control (the validated state) during commercial manufacture.” Okay that seems clear enough. However, according to one of our readers, the FDA is ignoring the traditional roles of QC/QA. Here is what the reader had to say.

Is More Monitoring The Solution?
“One area of interest is the stage 3 requirements for the new FDA guideline on validation. It is generating a considerable amount of interest because of the additional requirements imposed by the guideline. The FDA has defended the strategy (PDA/FDA Joint Conference 2011) on a claim that many recalls could have been avoided by more process monitoring. I have done QC and QA for over 30 years and seriously question this premise. The FDA is ignoring the traditional role of both QC and QA in reviewing results as they are generated. It is my experience, in several firms, that these folks almost instinctively recognize trends and address them as they arise. It is only the most irresponsible of firms that would release a product at the limits or approaching the limits. Further, in monitoring recalls, especially the high profile ones, I am hard pressed to identify even a small fraction that would have been predicted by more monitoring. If anything, I think firms know of issues and are using risk assessments to justify release of marginal product, where in the older black-and-white regulatory environment, they would have been rejected.” The reader went on to pose a question, which I sent out for our monthly “Ask the Board” feature to members of the Life Science Leader editorial advisory board. The question: “Has quality risk management as practiced by the FDA improved or impoverished the quality of products?”

Is The FDA On A “Do Something” Binge?
“While we can all rattle off the benefits of a proper risk assessment, it is often used – and now being mandated – in the evaluation of failures (quality or compliance),” the reader continued.. “Unfortunately, the FDA’s practice has contributed to the skepticism. One of the FDA’s first public applications of risk management was their use of it to “justify” their noncompliance with the biannual inspection requirement. While I don’t fault the prioritization logic, it was clearly used to justify noncompliance with the law. Now they seemed surprised when industry does the same. I recognize that the question isn’t politically correct. But, I think the FDA has gotten on a “do-something” binge without really understanding how the business they regulate works. It is ruining their credibility and not making the public safer.” If you would like to weigh in on this issue, feel free to drop me an email and share your thoughts. rob.wright@lifescienceconnect.com