This episode we are talking about an area that we don’t hear much about. It has to do with some of the ambiguity on quality and process in the proposed FDA guidance for the industry on the current good manufacturing practice the guide for human compounding outsourcing facilities under Section 503B. Specifically we are discussing the Vial Capping process. I was introduced to this subject by Amy Summers who had just written an article with Neal Higgins from West Pharma about it.  I wanted to do this episode because I have been told that people don’t realize how hugely connected sterility assurance is to container closure integrity and we focus so much on sterility testing but never really talk about, and clearly we should, container closure integrity.  I also want to mention that even though throughout this we are referring to cGMP and Section 503B there is also some important information and thoughts for r 503As so I hope they listen to this as well.

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