Process Validation - A Science based approach for Pharmaceutical Quality Assurance
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Process Validation - A Science based approach for Pharmaceutical Quality Assurance
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About this listen
This podcast outlines the essential standards for process validation within the pharmaceutical and biologics industries. It establishes a three-stage lifecycle approach that includes process design, process qualification, and continued process verification to ensure drug quality and consistency. The discussion emphasizes using scientific evidence and risk-based analysis to maintain manufacturing control from initial development through commercial production. This podcast provide a framework for meeting Current Good Manufacturing Practice (CGMP) requirements to guarantee product safety and efficacy.
#processvalidation #FDA
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