Preparing for an MHRA audit

 Preparing for an MHRA audit (Medicines and Healthcare products Regulatory Agency, UK) requires a very structured approach because their inspections are thorough and focus on GMP compliance, data integrity, and patient safety.

Here’s a detailed step-by-step plan you can follow:

1. Understand the Scope

Type of audit: Routine inspection, triggered inspection, or follow-up.

Standards applicable: EU GMP (EudraLex Volume 4), GDP guidelines (if distribution), MHRA GxP data integrity guidance.

Facility scope: Manufacturing, QC lab, storage, distribution, clinical trial site, etc.

2. Documentation Preparation

MHRA inspectors often say "If it isn’t documented, it didn’t happen."

You should ensure:

Quality Management System (QMS)

Updated SOPs (Standard Operating Procedures) with revision history.

Deviation, change control, and CAPA records up-to-date.

Internal audit reports and follow-up actions.

Manufacturing & Testing Records

Batch Manufacturing Records (BMRs) – reviewed, signed, error-free.

Analytical raw data (chromatograms, balances logs, lab notebooks).

Equipment & Calibration

Calibration logs, preventive maintenance records.

Equipment qualification (IQ, OQ, PQ) reports.

Training

Up-to-date training records for all employees in scope.

Evidence of GMP and data integrity training.

3. Data Integrity Readiness

Ensure ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available).

Audit your systems for:

Unique user logins (no shared accounts).

Audit trails enabled and reviewed regularly.

No “backdating” or unauthorized changes.

Be ready to demonstrate how you ensure raw data is secure and retrievable.

4. Facility & Equipment Readiness

Perform a GMP walkthrough before the audit:

No expired labels or materials in production or storage.

Clean and well-maintained production and lab areas.

Proper segregation of quarantined, released, and rejected materials.

Ensure logbooks are filled properly — no blank spaces or missing entries.

5. Conduct a Mock Inspection

Have an internal or external auditor simulate an MHRA inspection.

Practice:

How you will greet inspectors.

How you will escort them to relevant areas.

How you will provide requested documents quickly and accurately.

Train staff to answer only what is asked — clearly and factually.

6. Common MHRA Focus Areas

Change control effectiveness.

Batch release process and Qualified Person (QP) oversight.

Computerised systems validation (CSV).

Supplier qualification and vendor audits.

OOS (Out-of-Specification) and deviation investigations quality.

Risk management in line with ICH Q9.

7. On the Day of Audit

Welcome the inspector and provide a brief company introduction.

Assign:

Audit coordinator – main contact for the inspector.

Document runner – fetches records.

Note taker – documents every request and discussion.

Keep all original records available; don’t delay document retrieval.

8. Post-Audit Actions

Respond to any observations (critical, major, other) within MHRA’s deadline.

Use root cause analysis and robust CAPA plans.

Communicate internally so the entire team learns from findings.