The PQRI Aseptic Processing Working Group. What was it? What Did It Cover? What Conclusions Did It R

The Aseptic Processing Working Group was formed in December 2002 within the Product Quality Research Institute (PQRI) to provide input on specific topics presented in FDA’s concept paper “Sterile Drug Products Produced by Aseptic Processing.” PQRI is a nonprofit organization designed to provide a neutral environment in which FDA, academia, and industry can collaborate on pharmaceutical product quality– related topics. For this reason PQRI was an appropriate choice in which to form such a group. As designed, it allowed members from FDA, industry, and academia to openly discuss the topics on the basis of science and then provide formalized clarifications and recommendations to FDA for their consideration and incorporation into FDA’s draft guidance on aseptic processing. The working group, totaling 41 members, began its work on23 December 2002 and issued its final report  on 10 March 2003.

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