If an inspector arrived next quarter, could your leadership team prove that the site is in control without launching a last-minute search for drawings, qualification records, deviations, and missing approvals?
That is the real test behind an MHRA or EU GMP inspection.
For a Southeast Asian manufacturer pursuing UK or European market access, the inspection…
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,…
