James D. Colandene

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James D. Colandene, PhD, is manager, Biopharmaceutical Product Sciences, 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

June 2nd 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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