Pharmaceutical Industry Adopting Lifecycle Models for Process Validation
This article was originally published in The Gold Sheet
The pharmaceutical industry is incorporating the lifecycle approach to process validation – and seeing some of its benefits after initial misgivings – while an FDA official discussed the elements of a robust process validation program and consequences when these are not in place. Industry is developing separate guidance on designing process validation studies for biotechnological drugs.
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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.