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

Wright,Glenn;

News

Article

May 1, 2003

Pharmaceutical Technology

Pharmaceutical Technology-05-01-2003

Volume2003 Supplement

Issue 2

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

Author(s):

Glenn E. Wright

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and provide formalized clarifications and recommendations to FDA to be considered and incorporated into FDA's draft guidance on aseptic processing.