The PQRI Aseptic Processing Working Group: What was it? What Did It Cover? What Conclusions Did It Reach? Why Was It Important?

May 1, 2003
Glenn E. Wright

Glenn E. Wright is chairman of the PQRI Aseptic Processing Working Group and a director of global regulatory affairs at Eli Lilly and Company.

Pharmaceutical Technology, Pharmaceutical Technology-05-01-2003, Volume 2003 Supplement, Issue 2

Members of FDA, industry, and academia formed a working group within PQRI to openly discuss topics from a scientific perspective and provide formalized clarifications and recommendations to FDA to be considered and incorporated into FDA's draft guidance on aseptic processing.