The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
Richard A. Lewis
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Richard A. Lewis is statistics lead, GMS TEC Shared Services, at GlaxoSmithKline.
Articles by Richard A. Lewis
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Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ BatchesPublished: July 1st 2017 | Updated:
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