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FDA Perspectives: Revising the 1987 Industry Guideline The Development of FDA's Guidance on Aseptic Processing

May 1, 2003
Richard L. Friedman

Richard L. Friedman is a microbiologist and is a senior compliance officer for sterile drugs and chairs CDER's Aseptic Processing Guideline Revision Working Group.

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

The authors describe the solicitation of industry input for the guidance through a process that included a 2002 meeting of the Advisory Committe on Pharmaceutical Science and the subsequent formation of the PQRI Aseptic Processing Working Group.