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Process Validation FDA Guidance - Implementation Approach | IVT

This is the second FDA Process Validation guidance. The original guidance was published in 1987. Since then, FDA has gained additional validation experience through regulatory oversight. The new guidance significantly changed the stated 1987 approach to validation and provides a comprehensive integrated approach. The guidance recommends a lifecycle approach to process validation comprising development activities and ongoing monitoring of commercial manufacturing. It further recommended enhancement to traditional process qualification protocols (PPQ). Industry is facing significant challenges in...

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