CBER's Perspective on Evaluation and Implementation of Rapid Microbial Methods
CAPT Simleen Kaur, at FDA, Lori Daane at bioMérieux and Jon Kallay at Charles River Microbial Solutions
About this talk
Conventional microbiological methods are established and have been used for detection and identification of microbiological contamination in biological products for decades. These methods are time consuming and can take several days or weeks to generate results. Rapid microbial methods use proprietary methods that utilize novel technologies and can provide efficient microbiological control and assurance to allow expedited release of products. Rapid methods can be implemented for in-process testing of pharmaceutical products, environmental monitoring and final release testing of biological products. This presentation will provide CBER's current thinking concerning validation and implementation of rapid microbial methods and their evaluation to demonstrate the suitability of rapid microbial methods used in testing and release of biological products.
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