Process Validation for Sterile Manufacturing - Pharmaceutical Technology

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PharmTech Europe

Process Validation for Sterile Manufacturing


William (JR) Humbert
Validation Manager,
Cook Pharmica

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This podcast discusses the 2011 FDA Guidance for the Industry, Process Validation: General Principles and Practices, and the impact the guidance has for biotechnology and pharmaceutical companies performing sterile manufacturing process validation.  The three stages of process validation in the guidance and their implications for sterile manufacturing are discussed.  The podcast concludes with a discussion regarding PAT tools that can assure a sterile manufacturer that sterile processes will remain in a validated state over the lifecycle of the sterile product.



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