ISPE Talks Process Validation: Managing CMOs, Figuring PPQ Batches
This article was originally published in The Gold Sheet
The pharmaceutical industry is proposing new approaches for managing validation activities of contract manufacturing organizations and for estimating the number of batches to run during process validation.
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Pharmaceutical manufacturers need to carefully plot out how they are going to manage the validation activities with their manufacturing partners. Not planning out these activities before the knowledge transfer can raise the ire of FDA.
The pharmaceutical industry is advancing ideas for estimating the number of batches to run during process validation as well as how to establish robust monitoring and testing programs for products on the market. Industry has been hammering out these details in the absence of many specifics in the FDA’s 2011 process validation guidance on these areas.
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