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

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September 1, 2004

Pharmaceutical Technology

Pharmaceutical Technology-09-01-2004

Volume2004 Supplement

Issue 6

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

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.

External Link - article-122728.pdf

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

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