Kashappa Goud Desai

Kashappa Goud Desai, PhD, is investigator, Biopharmaceutical Product Sciences, GlaxoSmithKline, [email protected]

Articles by Kashappa Goud Desai

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

ByJames 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.

Latest Updated Articles

Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ Batches
June 2nd 2017

Kashappa Goud Desai

Articles by Kashappa Goud Desai

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

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