Validation Lifecycle The bioprocess validation lifecycle involves qualification, process validation and continued process verification. During qualification, facilities, utilities and equipment are evaluated to ensure they are suitable for intended use. Process validation demonstrates the process is capable of consistently producing quality product meeting predetermined requirements. Three...
All biopharmaceutical products must undergo rigorous validation to demonstrate that the manufacturing process is capable of consistently producing a product meeting its predetermined specifications and quality criteria. Regulatory agencies like the FDA require pharmaceutical companies to have a formal process validation protocol in place and conduct validation at defined stages of development....
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