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EU GMP Certification for Vietnamese Pharmaceutical Manufacturers: A Step-by-Step Guide

For Vietnamese manufacturers, EU GMP certification involves defining the intended product and market, aligning with an EU importer and regulatory pathway, closing facility and quality-system gaps, completing qualification and validation, and passing an inspection. QA, engineering, regulatory affairs, validation, production, and senior management must work together because the route depends on the product, activities, importer,…

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