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...]
USP FAQ – HOW ARE MICROBIAL LIMITS AND OBJECTIONABLE (SPECIFIED) MICROORGANISMS DETERMINED
COMMENT A question that is frequently asked during consulting, webinars and seminars is how does one choose appropriate microbial limits, especially with non-sterile raw materials, intermediates and final products. The USP Microbiological Expert Committee has considered this issue and provided Guidance. Please read their considerations below. In determining the appropriate … [Read more...]
