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.
Douglas P. Nesta
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Douglas P. Nesta, PhD, is director, Biopharmaceutical Product Sciences, GlaxoSmithKline.
Articles by Douglas P. Nesta
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Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ BatchesPublished: June 2nd 2017 | Updated:
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