Process Validation Draft Praised Though Closer Alignment with ICH Supported
This article was originally published in The Gold Sheet
Executive Summary
Industry reacts to draft process validation guidance calling for FDA to, among other things, align it more closely to international principles, relax requirements for early-stage development, ease requirements for viral clearance studies, clarify that existing products would not have to be revalidated and ratify the standard three-batch approach as a minimum requirement.
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