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Pharmaceutical lndustry Proposes Ideas for Number of Batches, Monitoring Production

This article was originally published in The Gold Sheet

Executive Summary

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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