Free download · 51 checkpoints
GMP Inspection-Readiness Checklist
A GMP inspection-readiness checklist is a structured, area-by-area review of the systems an MHRA (or EMA/FDA) inspector will examine — from the quality system and data integrity to suppliers, CAPA and self-inspection. Work through the 51 checkpoints below to find your gaps before an inspector does.
Double Helix Pharma UK — GMP Inspection-Readiness Checklist
doublehelixpharma.co.uk/resources/gmp-inspection-readiness-checklist
01 Pharmaceutical Quality System (PQS)
EU GMP Ch.1 · ICH Q10- Quality Manual is current, approved and reflects how the site actually operates
- Quality policy and measurable quality objectives are defined and communicated
- Management review held at a defined frequency with documented, tracked actions
- Quality risk management (ICH Q9) is embedded in decisions, not retrofitted
- Product Quality Reviews (PQRs/APRs) are complete and on schedule for every product
- Quality metrics/KPIs are trended, escalated and acted on
02 Documentation & Data Integrity
ALCOA+ · Annex 11- Document control SOP in place; all SOPs are within their review date
- Good documentation practice followed — no uncontrolled forms or loose paper
- Data integrity policy applies ALCOA+ to both paper and electronic records
- Audit trails are enabled, reviewed and protected on all computerised systems
- Unique user logins and role-based access — no shared accounts
- Backup, archival and retention are defined and have been restore-tested
03 Personnel & Training
EU GMP Ch.2- Organisation chart is current; key roles and named deputies are defined
- Job descriptions capture GMP responsibilities (including QP duties)
- Role-based training matrix; GMP and data-integrity training are current
- Training effectiveness is assessed — not just attendance recorded
- Hygiene and gowning qualification for production and clean areas
04 Premises & Equipment
Annex 15 · Annex 1- Facility layout supports material/personnel flow with no cross-contamination risk
- Cleaning and sanitisation SOPs and records; cleaning validation where required
- Equipment qualified (URS/DQ/IQ/OQ/PQ) and within calibration
- Preventive maintenance is scheduled and recorded
- Utilities (HVAC, water, compressed gases) qualified and monitored
- Environmental monitoring programme in place where applicable (incl. Annex 1)
05 Production & Process Control
EU GMP Ch.5 · Annex 15- Process validation current; ongoing process verification in place
- Batch records reviewed; in-process controls defined and consistently met
- Line clearance procedures and records prevent product mix-ups
- Yield reconciliation performed and discrepancies investigated
- Labelling and packaging controls prevent mix-ups and errors
06 Quality Control & Laboratory
EU GMP Ch.6- Specifications and analytical methods are validated or verified
- OOS/OOT investigation procedure is followed — no invalidation without cause
- Reference standards, reagents and columns are controlled and in date
- Stability programme is ongoing and results are trended
- Sampling plans and retained/reference samples meet requirements
07 Materials & Supplier Management
EU GMP Ch.5 & Ch.7- Approved Supplier List maintained; suppliers qualified on a risk basis
- Supplier/vendor audits scheduled and current (especially APIs and sterile)
- Quality/technical agreements in place for all outsourced activities
- Incoming identity testing and API GMP evidence in place
- Goods received, quarantined and released under defined controls
08 Deviations, CAPA & Change Control
ICH Q10- Deviation system drives root-cause analysis, not just correction
- CAPA effectiveness checks are closed within agreed timelines
- Change control assesses regulatory and validation impact before implementation
- Open deviation/CAPA backlog is under control and any ageing is justified
09 Complaints, Recalls & Returns
EU GMP Ch.8- Complaint-handling procedure in place; complaints are trended
- Recall procedure tested by mock recall; out-of-hours contact confirmed
- Returns and falsified-medicine (FMD) procedures are defined
- Reporting routes to the MHRA / competent authority are understood
10 Self-Inspection & Inspection Readiness
EU GMP Ch.9- Self-inspection programme covers every GMP area on a defined cycle
- Previous inspection findings and CAPAs are closed and verified effective
- Site Master File is current and accurate
- Front-room/back-room, SME list and rapid document retrieval are ready
- Staff briefed on inspection conduct: answer the question asked, tell the truth, don't speculate
Turn the gaps into an inspection-ready operation
Found items you can't confidently tick? That's exactly where we work. Explore the services behind each section:
GMP & GDP AuditsIndependent gap assessment & mock inspectionContract QP / RP / RPiQualified Person cover and batch releaseQMS ImplementationBuild the PQS, SOPs and data-integrity controlsMIA / WDA Site ReadinessFrom application to a clean first inspection
Prefer the full write-up? Read the complete GMP audit-readiness guide.
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