Richard A. Lewis

Richard A. Lewis is statistics lead, GMS TEC Shared Services, at GlaxoSmithKline.

Articles

Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ Batches

James D. Colandene;Douglas P. Nesta;Kashappa Goud Desai;Richard A. Lewis

July 1st 2017

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.

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