Validation of Microbiological Methods – Expectations for Regulatory Compliance
Posted on October 7, 2014
By: Rajesh K. Gupta, Principal Consultant
Biologics Quality & Regulatory Consultants, LLC
Introduction Microbial contamination of drugs and biologics causes immediate adverse effects on health, including morbidity and mortality1-3, as well as long-term adverse impacts, such as cancer, auto-immune and other diseases. Additionally, microbial contamination of drugs can alter their chemistry...
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Biologics Quality & Regulatory Consultants, LLC, Method Verification, microbial safety, microbiological methods, microbiology, Rajesh K. Gupta, regulatory compliance
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