IS A WARNING LETTER FORTHCOMING? A Pharmacia Upjohn subsidiary of Pfizer (Kalamazoo, MI) received a FDA Form 483 following an inspection from June 23 through July 9, 2015. This eight Observation 483 covered both non-sterile and aseptic issues. This audit used the Agency’s recently introduced team-based inspection approach and included Thomas Cosgrove, … [Read more...]
2015 United States Pharmacopeia (USP) Microbiological General and Information Chapters Training Program
7-Part Live Training Program Starts September 30, 2015 Instructor: Barry A. Friedman Ph.D. The United States Pharmacopeia (USP) contains a number of chapters relating to microbiology within its General and General Information Chapters. These Chapters present information that relate to both non-sterile and aseptic processing. Several of these chapters have been … [Read more...]
NEW DRUG MICROBIOLOGY STAFF MEMBER PRESENTS INFORMATION ON ON-GOING PILOT PROGRAM
PROGRAM INCLUDES THE REVIEW OF NON-STERILE PRODUCTS John W. Metcalfe, Ph.D., of the New Drug Microbiology Staff at CDER gave an excellent, informative presentation on “Regulatory Review Perspectives for Non-Sterile Drug Products” at the PDA Global Microbiology Conference on Monday, October 21, 2013 in Bethesda, MD. This presentation presented information on a Pilot Program … [Read more...]
