We have a number of compendial (USP and Ph. Eur.) and technical (PDA TR#33) documents at our disposal for the validation of rapid microbiological methods. However, specific guidance is lacking at the regulatory level, as there are no comprehensive written policies from the FDA, EMA, TGA or the Japanese PMDA. During the PDA 5th Annual Global Conference on Pharmaceutical Microbiology, a question was asked to FDA panelists when the Agency would develop a clear guidance document on RMMs. Dr. David Hussong, Director, Microbiology, CDER, responded that In the next few years there will be an internal document that the agency will follow.
We have a number of compendial (USP and Ph. Eur.) and technical (PDA TR#33) documents at our disposal for the validation of rapid microbiological methods. However, specific guidance is lacking at the regulatory level, as there are no comprehensive written policies from the FDA, EMA, TGA or the Japanese PMDA. During the PDA 5th Annual Global Conference on Pharmaceutical Microbiology, a question was asked to FDA panelists when the Agency would develop a clear guidance document on RMMs. Dr. David Hussong, Director, Microbiology, CDER, responded that In the next few years there will be an internal document that the agency will follow.