DRUG STERILIZATION PROCESS REVIEW AT NDA/ANDA PREAPPROVAL INSPECTIONS
This article was originally published in The Tan Sheet
Executive Summary
DRUG STERILIZATION PROCESS REVIEW AT NDA/ANDA PREAPPROVAL INSPECTIONS rather than in the body of marketing applications is supported in recent industry comments to FDA. The Pharmaceutical Manufacturers Association and the Parenteral Drug Association submitted the comments in response to the agency's December 1993 final draft of its sterilization process validation guidelines ("The Tan Sheet" Dec. 20, 1993, in Brief).