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…
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?…
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,…
