Guide

How to Prepare for an MHRA Inspection

25 February 2026•12 min read

MHRA inspections can occur with little notice – sometimes just a few days. Being caught unprepared can result in serious consequences including warnings, fines, suspension of your WDA(H), or worse.

This guide provides practical steps to ensure you're always inspection-ready. Learn what inspectors look for, common findings, and how to prepare successfully.

Understanding MHRA Inspections

The MHRA (Medicines and Healthcare products Regulatory Agency) is the UK regulatory authority responsible for ensuring medicines meet acceptable standards of safety, quality, and efficacy. They conduct inspections of:

  • Wholesale Dealers (WDA(H)) – pharmaceutical wholesalers and distributors
  • Manufacturers (MIA) – medicine manufacturers
  • Importers – companies importing medicinal products into the UK
  • Parallel Distributors – companies trading medicines within the UK/EEA

Types of MHRA Inspections

Routine Inspections

Scheduled based on risk assessment and compliance history

For-Cause Inspections

Triggered by complaints, deviations, or adverse events

Pre-licensing Inspections

For new WDA(H) applications

Follow-up Inspections

To verify corrective actions from previous inspections

What Inspectors Look For

MHRA inspectors examine how you comply with GDP (Good Distribution Practice) requirements. Key areas include:

Quality Management System

  • Documented QMS?
  • Procedures current and followed?
  • Deviations and CAPAs managed?
  • Management review evidence?

Responsible Person

  • Named RP on WDA?
  • Duties and authority defined?
  • Adequate time and resources?
  • Evidence of RP oversight?

Premises & Storage

  • Temperature monitoring and records?
  • Calibration of equipment?
  • Premises cleanliness?
  • Product segregation?

Transportation

  • Cold chain controls?
  • Qualified carriers?
  • Transit temperature monitoring?
  • Packaging validation?

Documentation

  • Records complete and accurate?
  • Quick retrieval?
  • Document control effective?
  • Retention period compliance?

Training

  • Staff trained on GDP?
  • Training documented?
  • Competency assessed?
  • Records accessible?

Common MHRA Inspection Findings

Based on MHRA inspection trends, common findings include:

  • ⚠️Inadequate temperature monitoring and control
  • ⚠️Poor supplier qualification procedures
  • ⚠️Incomplete documentation or record-keeping gaps
  • ⚠️Insufficient training or competency assessment
  • ⚠️Weak deviation and CAPA management
  • ⚠️Lack of or inadequate self-inspections
  • ⚠️Responsible Person not having adequate time or authority
  • ⚠️Outdated or inadequate SOPs

Inspection Preparation Checklist

📋 Before the Inspection

  • Maintain an inspection folder with key documents readily accessible
  • Conduct regular self-inspections – minimum annually covering all GDP areas
  • Address findings promptly – don't let issues accumulate
  • Keep training records current – all staff should have GDP training
  • Maintain temperature records – both storage and transit
  • Keep SOPs current – review and update regularly
  • Document everything – if it's not documented, it didn't happen
  • Prepare a site tour – ensure presentation-ready at all times

🎯 During the Inspection

  • Be cooperative and professional – inspectors appreciate openness
  • Answer questions honestly – don't guess or fabricate
  • Provide evidence – have documents ready
  • Take notes – record what inspectors ask and say
  • Don't argue – if you disagree, explain politely
  • Ask for clarification – ensure you understand what's being asked
  • Brief key staff – ensure everyone knows their role

✅ After the Inspection

  • Review the report carefully – understand all findings
  • Respond promptly – meet deadlines for responses
  • Provide evidence of corrective actions – where possible
  • Implement systemic fixes – don't just address the symptom
  • Learn from findings – use them to improve your QMS

Tips for Success

  • 1Don't wait for an inspection – maintain continuous compliance
  • 2Think like an inspector – what would you look for?
  • 3Keep it simple – complex systems are harder to maintain
  • 4Train everyone – not just QA staff
  • 5Document everything – especially deviations and corrective actions
  • 6Learn from others – review MHRA inspection reports and warning letters
  • 7Seek help – if you're unsure, consult with experts

Need Help Preparing?

Regular self-inspections are the best way to identify gaps before the MHRA arrives. I offer pre-inspection readiness audits to help you identify and address potential issues before they become problems.

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