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.

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