This morning, we just aired a webcast on FDA's revised process validation guidance. Speaking was FDA's chief enforcer, Joe Famulare, as well as consultants Jim Agalloco, Bikash Chatterjee, and Line Lundsberg-Nielsen of NNE-Pharmaplan. Speakers addressed interesting and controversial topics, including industry's criticism of the draft guidance, and questions of how to apply it to legacy products. Mr. Agalloco envisions a "hybrid" approach being used for these types of products, while Ms. Lundsberg outlined an approach using Quality by Design principles, reinforced by the draft guidance's language. Mr. Chatterjee discussed how Six Sigma principles could be applied to the validation process.
All of the speakers pointed out the potential benefits of using principles outlined in the new draft guidance. However, Mr. Famulare ended his presentation with an important reminder: failure to use smart validation concepts could lead to very public culpability in the form of a consent decree.
It's all very well and good to discuss all the great things that will come of working smarter with voluntary initiatives such as PAT, statistical process control, design of experiments, Lean Six Sigma. But, if more companies don't start working smarter and applying more of these concepts, their use may eventually be mandated. Just like seat belts in cars....
I interviewed Joe Famulare briefly on the guidance, industry response, and what's being done to get all inspectors on the same page...it should be up on our web site soon, as should the archived webcast, which is definitely worth a look/listen.