The Introduction of Qualitative Rapid Microbiological Methods for Drug-Product Testing

Pharmaceutical Technology, Pharmaceutical Technology-09-01-2004, Volume 2004 Supplement, Issue 6

FDA recently approved the first PAT applications for the introduction of rapid microbial testing of drug products and pharmaceutical-grade waters. Officials from FDA and GlaxoSmithKline worked together to ensure the appropriate scientific evaluation of the methods. Team members report on the successful validation approach and identify technical issues to be considered for the future.