WHO-GMP Export Readiness Checker

Is your Site Master File (SMF) prepared in CTD format (ICH M4 Volume 3) covering all manufacturing operations?

Do you hold a current EU-GMP certificate issued after an EMA-authorised inspection, or equivalent WHO-GMP valid for EU?

Are you aware of EU-GMP Annex 18 (Principle for Interpretation for Non-EU Country Sites) and have you assessed your compliance?

Have you identified a Qualified Person (QP) in an EU Member State who will perform batch release for your products?

Is a formal change control system in place for all changes to manufacturing processes, equipment, materials, and methods?

Is stability data available in ICH Q1A format for all proposed export products, covering proposed shelf life?

Are all analytical testing methods validated per ICH Q2 with full validation reports available for regulatory submission?

Are all Active Pharmaceutical Ingredients (APIs) used in your manufacturing tested against a validated specification with full CoA?

Are batch manufacturing records complete, contemporaneously written, reviewed, and retained for the required period?

Is there a documented Out-of-Specification (OOS) investigation procedure following EU-GMP Chapter 6 guidance?

Is cleaning validation completed for all equipment manufacturing more than one product, with documented acceptance criteria?

Is your purified water system qualified (DQ, IQ, OQ, PQ) and subject to ongoing monitoring and alert/action limits?

Have controlled storage areas been temperature-mapped seasonally, with data logger records retained?

Is a documented pest control programme in place with external contractor records and internal log?

Are all GMP-relevant personnel trained, with training records showing competence assessment?

Have you appointed a Pharmacovigilance contact and established an adverse event reporting system for EU market?

If supplying an API, has a Drug Master File (DMF / ASMF) been filed with EMA or EU Member State health authority?

Is there a signed Technical Agreement / Quality Agreement template ready for EU CMO or distribution partners?

Are Good Distribution Practice (GDP) requirements for temperature-controlled logistics documented and contracted to your freight partner?

Has a mock recall exercise been conducted in the last 12 months, with results documented and recall time ≤4 hours?

WHO-GMP + EUGMP certificate → DMF/ASMF filing → Technical Agreement with EU CMO → Batch release by EU QP → EU import via MIA holder

WHO-GMP + EU-GMP inspection → Marketing Authorisation Application (MAA) → EU QP batch release → Distribution via GDP-compliant 3PL

GMP + EU food law compliance → No MA required → EU importer as FBO (Food Business Operator) → GDP logistics