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EU GMP gap analysis banner for Vietnamese pharma facilities showing a manufacturing plant with HVAC and utility systems

EU GMP Gap Analysis for Vietnam Pharma Facilities

BlogAugust 21, 202655Views 0Likes 0Comments

For a Vietnamese pharmaceutical manufacturer planning EU market entry, the most expensive question is not, “Can this site pass an EU GMP inspection?” It is this: Can the existing facility support the intended product and EU supply model without creating an open-ended remediation programme, an unmanageable shutdown, or stranded CAPEX? That distinction matters. A conventional…

EU GMP certification in Vietnam banner showing a pharmaceutical technician operating a vial filling line in a GMP cleanroom facility

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

BlogAugust 7, 2026126Views 0Likes 0Comments

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,…