GDP Audit Checklist for UK Wholesalers

1. Quality Management System

• Quality manual is current, approved, and version-controlled
• Document control procedure covers creation, review, approval, and archiving
• Records are complete, accurate, and retrievable within 24 hours
• Quality agreements in place with all contract service providers (GDP 7.5)
• Change control process documented and followed
• Annual Quality Review conducted and documented
• Management review meetings held at defined intervals with minutes

2. Personnel and Training

• Organogram shows clear reporting lines and responsibilities
• Job descriptions for all key roles documented
• Training matrix in place covering all GDP requirements
• Training records complete and up to date for all staff
• GDP training conducted before handling medicinal products
• Annual refresher training documented
• Competency assessments completed for responsible tasks

3. Premises and Temperature Control

• Premises suitable for intended storage (clean, secure, pest-free)
• Temperature mapping conducted and documented
• Temperature monitoring system in place with alarms
• Cold chain procedures for temperature-sensitive products
• Calibration records for temperature monitoring equipment
• Temperature excursion procedures documented and followed
• Regular review of temperature data and trends
• Warehouse segregation procedures for different product categories

4. Operations and Supply Chain

• Standard Operating Procedures (SOPs) for all key processes
• Goods receipt procedure with identity and quantity checks
• FIFO (First In, First Out) rotation implemented
• Returns handling procedure in place and followed
• Recall procedure documented and tested
• Supplier qualification and approval process in place
• Purchasing procedures ensure products are from approved sources
• Transportation temperature control procedures for distribution

5. Deviations, Complaints, and CAPA

• Deviation procedure documented with clear classification (critical, major, minor)
• All deviations documented, investigated, and closed within agreed timelines
• Root cause analysis conducted for all deviations
• CAPA process linked to deviations with effectiveness checks
• Complaints procedure in place and followed
• Complaint investigations documented with outcomes
• Periodic trend analysis of deviations and complaints

6. Self-Inspection Programme

• Annual self-inspection schedule documented
• Self-inspection procedure in place
• Trained auditors (internal or external) conduct audits
• Self-inspection reports document findings and corrective actions
• Follow-up on corrective actions verified and closed
• Self-inspection records retained as per retention requirements

Common MHRA Inspection Findings

Understanding common findings helps you focus on high-risk areas. The most frequent issues include:

• Inadequate temperature monitoring and excursion handling
• Out-of-date or uncontrolled documentation
• Incomplete training records or lack of competency assessments
• Failure to investigate deviations within required timelines
• Weak supplier qualification and ongoing monitoring
• Missing or inadequate quality agreements
• Incomplete batch traceability records

How to Prepare for Your Audit

1. 1
   Conduct a pre-audit gap analysis

   Use this checklist to identify weaknesses before the auditor does.

2. 2
   Assign preparation responsibilities

   Designate team leads for each area to gather documentation.

3. 3
   Organise documentation

   Ensure records are retrievable within 24 hours as required.

4. 4
   Run a mock inspection

   Practice the audit process to build team confidence.

5. 5
   Prepare corrective actions

   Address known gaps before the audit begins.