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Ensuring Biopharmaceutical Quality: A Comprehensive Guide to Process ValidationAll 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....0 Commenti 0 condivisioni 490 Views 0 Anteprima