Guide
GDP Compliance Checklist for UK Pharmaceutical Wholesalers
25 February 2026•10 min read
Maintaining GDP (Good Distribution Practice) compliance is essential for pharmaceutical wholesalers operating in the UK. The MHRA conducts regular inspections, and failure to comply can result in warnings, fines, suspension, or revocation of your WDA(H) authorisation.
This comprehensive checklist covers the key areas you need to address to maintain compliance and stay inspection-ready throughout the year. Use this as your ongoing compliance guide.
1Quality Management System (QMS)
- Quality Manual – current, approved, and version-controlled
- Document Control – system for creating, reviewing, approving, and archiving
- Records Management – complete, accurate, and retrievable within 24 hours
- Quality Agreements – signed agreements with all contract service providers (GDP 7.5)
- Change Control – documented process for managing changes
- Deviation Management – all deviations documented, investigated, and CAPA where necessary
- Annual Quality Review – regular review of quality performance indicators
2Responsible Person (RP)
- Named RP listed on WDA(H) with appropriate qualifications
- RP Duties Document – clear definition of responsibilities (per Human Medicines Regulations 2012, Regulation 45)
- RP Availability – adequate cover for absence
- Training Records – RP has current GDP knowledge and competency
- Cogent Gold Standard – consider certification for demonstrating competence
3Premises & Storage
- Temperature Monitoring – continuous monitoring with alarms (GDP 3.2)
- Calibration – thermometers and monitoring equipment calibrated
- Temperature Mapping – regular mapping of storage areas (minimum annually)
- Segregation – proper separation of products
- Security – adequate measures to prevent unauthorized access
- Cleanliness – premises clean and maintained
- Pest Control – regular treatments with documented records
4Transportation & Cold Chain
- Cold Chain Procedures – documented procedures for temperature-controlled transport (GDP 3.3)
- Qualified Carriers – transportation providers qualified and audited
- Temperature Logs – maintained for all shipments including last mile
- Packaging Validation – qualified packaging for temperature-sensitive products
- Transit Monitoring – real-time temperature monitoring
5Procurement & Supplier Qualification
- Supplier Qualification – all suppliers qualified before first supply (GDP 5.2)
- Purchase Orders – controlled purchasing process
- Product Verification – process for verifying authenticity (FMD compliance)
- Batch Traceability – ability to trace products forward and backward
- No unauthorized suppliers – only verified sources
6Complaints & Recalls
- Complaint Procedure – documented process for handling product complaints
- Investigation Timelines – all complaints investigated within defined timelines
- Recall Procedure – documented with defined escalation path
- Mock Recalls – regular testing of traceability (minimum annually)
- CAPA System – corrective and preventive action with root cause analysis
7Training & Competency
- GDP Training – all staff have current training appropriate to role
- Job Descriptions – clear roles and responsibilities documented
- Ongoing Training – regular refresher training (minimum annual)
- Competency Assessment – staff competency documented
- Training Records – complete and readily accessible
8Self-Inspections (Internal Audits)
- Audit Programme – scheduled covering all GDP areas
- Audit Scope – self-inspections cover all aspects, not just documentation
- Audit Reports – documented findings with evidence and classifications
- Corrective Actions – tracked to completion within agreed timelines
- Audit Frequency – high-risk areas more frequently (minimum annually)
Need Help Preparing for an MHRA Inspection?
Regular self-inspections are the best way to ensure you're always ready for an MHRA inspection. I offer comprehensive GDP consulting and audit services to help you identify gaps and achieve compliance.