Thursday, January 8, 2009

FDA Draft Guidance On Process Validation

The FDA recently released a draft guidance for new process validation. The guidance says that manufacturers would have to increase sampling and testing, and monitor process performance more closely during the early stages of commercial manufacturing, according to the FDA's Guidance for Industry - Process Validation: General Principles and guidance. Once finalized, this guidance replaces the FDA's process validation guidance issued in 1987. The new guidance applies to pharmaceuticals, biologics and active pharmaceutical ingredients. It will cover the 3 stages of process validation — process design, process qualification and continued process verification.

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