ISPE PQLI®) Guides Under Development

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PQLI Part 5 – Process Validation

Relatively short documents are being written to provide considerations for practical application of a lifecycle approach to process validation to follow recommendations given in FDA’s Guidance for Industry – Process Validation: General Principles and Practices, January 2011. These documents will discuss application of concepts and provide examples. Highest priority is being given to topics perceived as most significantly changed compared with previous process validation expectations including:

Topic 1: Determining and Justifying the Number of Process Validation Batches

Topic 2: Applying Continued Process Verification Expectations to New and Existing Products

Last Update: 13 June 2013

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