EU GMP Readiness Checklist — 12 Key Areas
1
Quality Management System
Fully documented QMS per EU GMP Annex 11. SOPs for all critical processes. Change control system operational.
2
Personnel & Training
Qualified Person (QP) identified. Training records for all GMP-relevant staff. Organisational chart.
3
Premises & Equipment
EU GMP Annex 15 — facilities validation. Equipment qualification (IQ/OQ/PQ). Calibration records.
4
Documentation System
Batch Manufacturing Records (BMR). Deviation management. CAPA system. Annual Product Quality Review (APQR).
5
Production Controls
In-process controls. Environmental monitoring. Clean room qualification. Cross-contamination prevention.
6
Quality Control & Testing
EU Pharmacopoeia methods validated. Reference standards traceable to Ph. Eur. Out-of-Specification (OOS) procedure.
7
Outsourced Activities
Contract manufacturers and labs audited. Technical agreements in place. Change notification procedure.
8
Complaints & Recalls
Written recall procedure. EU rapid alert system (RASFF) awareness. Complaint handling log.
9
Self-Inspection
Annual self-inspection programme. Written reports. CAPA followed up.
10
Computerised Systems (Annex 11)
CSV (Computer System Validation) for all GMP-relevant software. Audit trail enabled. Backup procedure.
11
EU Regulatory Submissions
CTD dossier format. CEP (EDQM) or ASMF prepared. EU-facing SMF (Site Master File).
12
Pre-Approval Inspection Readiness
Mock inspection conducted by third party (TÜV SÜD / SGS / Intertek). PAI response protocol.