How to prepare WHO Audit

 Preparing for a WHO audit (World Health Organization inspection) is similar in spirit to preparing for any stringent GMP inspection, but it comes with WHO-specific expectations, especially if your facility manufactures pharmaceuticals for WHO-prequalified programs or supplies to UN agencies.

Here’s a step-by-step guide you can follow:

1. Understand the WHO Audit Scope

Check the audit notification letter — WHO typically shares the product(s), dossier reference, and the type of inspection (GMP, GDP, GCP, or prequalification).

Review WHO TRS (Technical Report Series) guidelines, especially:

WHO GMP Guidelines (TRS 986 Annex 2, TRS 961 Annex 3, etc.)

WHO Good Distribution Practices

WHO guidance on pharmaceutical water systems, HVAC, validation, etc.

Focus on critical quality systems: deviations, OOS/OOT, change control, CAPA, complaint handling, data integrity.

2. Review and Update GMP Documentation

SOPs: Ensure they are current, approved, and reflect actual practices.

Batch Manufacturing Records: Complete, error-free, reviewed, and signed.

Validation Master Plan: Includes process, cleaning, analytical method, equipment, and utilities validation.

Calibration & Maintenance Records: Updated logs for all GMP-critical equipment.

Training Records: Documented training for all relevant personnel.

Data Integrity Compliance: Audit trails enabled, no backdating, complete raw data.

3. Conduct a Mock Audit

Perform an internal self-inspection simulating WHO’s approach:

Traceability: pick a product batch and follow it from raw material to release.

Cross-check: verify alignment between SOPs, records, and actual floor practice.

Data integrity spot checks: review audit trails in LIMS/PLC systems.

If possible, engage an external GMP consultant for an independent review.

4. Ensure Manufacturing Areas Are Inspection-Ready

Clean & Organize: No unnecessary items in production; label status (clean, in use, under maintenance).

Logbooks: Updated and readily available.

Material Flow & Personnel Flow: Must match approved layouts.

Environmental Monitoring: Records complete and within limits.

5. Prepare Staff for the Audit

Train key staff on:

How to answer auditors: be honest, concise, factual.

Where documents are stored.

The company’s quality policy and basic product knowledge.

Assign escort and note-taker teams for each auditor.

6. Address Common WHO Focus Areas

WHO inspectors frequently look closely at:

Supplier qualification & material control.

Change control effectiveness.

CAPA closure timelines.

Handling of deviations & OOS results.

Water system control and monitoring.

Cold chain & storage conditions.

Data integrity and ALCOA+ principles.

7. Prepare for Closing Meeting & Post-Audit Actions

During the audit, maintain a daily issue log for observed concerns.

At closing, clarify any misunderstanding with the auditor.

After the audit:

Categorize observations (Critical, Major, Minor).

Create a CAPA plan with timelines (typically ≤ 30 days for WHO).

Implement and document corrective actions.

✅ Tip: WHO inspectors often go deeper into public health risk assessment — so they expect you to have robust risk management (ICH Q9 principles) and product quality reviews.