EU GMP Certification Archives

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,…

Pharmaco Global blog banner titled Design for Export, comparing EU GMP, WHO GMP, and USFDA cGMP compliance pathways for pharmaceutical facility design. The dark navy visual shows a gowned scientist in a cleanroom operating a stainless steel processing vessel, alongside a filling line of capped vials, a container ship at a port, and a world map with connected export routes. Icons highlight three pillars: Compliance, Facility Design, and Export. The headline advises pharmaceutical manufacturers to choose the right GMP pathway before facility decisions lock in. A closing tagline reads: build compliant facilities and unlock global markets across regulated regions.

EU GMP vs WHO GMP vs USFDA cGMP: A Guide for Pharmaceutical Exporters

BlogJuly 30, 2026218Views 0Likes 0Comments

Choosing the wrong GMP pathway can delay facility approvals, increase project costs, and restrict access to target export markets. While EU GMP, WHO GMP, and USFDA cGMP share similar quality principles, they differ in regulatory authority, inspection requirements, compliance evidence, and market application. This guide compares the three frameworks, explains what their certificates and inspections…

EU GMP certification hero banner featuring a Grade A ISO 5 aseptic filling line behind glass, +15 Pa differential pressure display, and a five-step process: gap analysis, remediation and qualification, inspection readiness, inspection and CAPA closure, and GMP certificate issued

EU GMP Certification Process: From Gap Analysis to Inspection Outcome

BlogJuly 20, 2026795Views 0Likes 0Comments

The EU GMP certification process is the practical journey from defining the correct regulatory pathway to demonstrating that a pharmaceutical site, its systems, people, and quality controls can consistently support compliant manufacture. This guide is for regulatory affairs professionals, QA managers, engineering teams, and project owners preparing human medicinal product facilities for EU inspections. It…