How to Prepare for a WHO PQP Facility Audit

Essential Steps to Prepare for a WHO PQP Facility Audit

For pharmaceutical manufacturers aiming to supply to global health organizations like UNICEF, Global Fund, or GAVI, obtaining WHO Prequalification is a key milestone. At the heart of this process lies the WHO PQP facility audit, a rigorous on-site inspection that verifies GMP compliance. Preparing for this audit requires strategic planning, robust quality systems, and thorough documentation control. This guide outlines how pharmaceutical professionals can prepare effectively for a WHO PQP facility audit and improve their chances of success.

Understanding the WHO PQP Audit Process:

The WHO PQP audit assesses whether a manufacturing site meets the standards defined in WHO TRS 986 and TRS 961. It includes an inspection of facilities, systems, documents, and personnel capabilities and is conducted by a team of trained WHO inspectors over 3–5 days.

Step 1: Internal GMP Readiness Assessment

Begin by conducting an internal self-inspection using WHO’s GMP checklist. This helps identify gaps early and prioritize remediation.

Use WHO TRS 986 Annex 2 as your reference document
Check alignment with ICH Q7/Q10 and WHO GMP clauses
Audit the entire quality system: change control, deviation management, CAPA, validation, etc.

Step 2: Assemble the Pre-Audit Documentation Package

WHO requires the submission of key documents before inspection scheduling. Ensure the following are current and accurate:

Site Master File (SMF): Comprehensive overview of the site’s infrastructure and operations
Validation Master Plan (VMP): Details of ongoing and completed validation activities
SOP index and key GMP procedures: Including deviation, change control, CAPA, training, cleaning
Recent batch records: For all products under review
Organograms and equipment lists

Also Read: Impact of Harmonization on International Pharmaceutical Trade and Compliance

Step 3: Train Subject Matter Experts (SMEs)

The success of the audit heavily depends on how confidently your personnel respond to inspector questions. Conduct structured SME training to ensure:

QA, QC, Production, Engineering, and Warehouse leads know the SOPs
SMEs understand the WHO inspection process and global expectations
Consistent responses are given based on documented processes

Step 4: Simulate a WHO PQP Audit

Organize mock audits with internal or external auditors familiar with WHO’s approach. Simulate real conditions including:

Opening and closing meetings
Facility tour walkthroughs
Batch record traceability checks
Stability testing protocol evaluation
Audit trail review of electronic systems

Step 5: Prepare an Audit War Room and Response Plan

Set up a designated room equipped with:

Printed and digital SOPs, BMRs, SMF, and VMP
Assigned scribe, runner, SME, and QA point of contact
Document request log with tracking and delivery timelines
Audit room briefing board with daily inspector feedback summary

Also Read: The Role of Inspection History in Global Market Access Decisions

Step 6: Clean and Calibrate the Facility

Ensure all cleaning logs and sanitation protocols are up to date
Calibration certificates must be current for all equipment
Gowning procedures, HVAC maintenance, pest control—all should be audit-ready

Step 7: Inspect Stability Study Controls

As WHO places strong emphasis on long-term and accelerated stability, confirm the following:

Data complies with ICH Q1A(R2) guidelines
Out-of-trend (OOT) and out-of-specification (OOS) results are properly investigated
All chambers have current qualification and continuous monitoring logs
Stability summaries support shelf-life claims on packaging

Step 8: Review Previous Audit Findings

If the facility has undergone other audits (e.g., by USFDA, EMA, or local NRAs), analyze the findings and corrective actions. WHO inspectors may ask about repeat deficiencies and systemic CAPA effectiveness.

Step 9: Rehearse the Opening Meeting

QA Head should prepare a site presentation
Explain company structure, site layout, quality systems, and prior WHO engagements
Be ready to present organization charts and key quality metrics

Step 10: Build a CAPA Framework in Advance

Prepare a template to log and respond to findings during the audit. Include fields for:

Observation classification (Critical, Major, Other)
Root cause analysis (RCA)
Corrective steps
Preventive actions
Timeline and responsible department

Also Read: Evolution of International GMP Inspection Standards and Practices

Step 11: Prepare Teams for Real-Time Traceability Requests

WHO inspectors will often trace a batch from start to finish. Make sure:

Raw material receiving, storage, issuance, and usage are well-documented
Environmental monitoring data aligns with production timelines
QC testing records are linked with analytical methods and equipment IDs

Step 12: Align SOPs with WHO GMP Expectations

Ensure your SOPs reflect actual practices, include version control, and are compliant with WHO GMP modules including:

Document control
Training
Deviations and OOS handling
Self-inspections
Complaint handling

Post-Audit Considerations:

Submit your CAPA plan within 30 days
Track CAPA timelines and implementation status
Be ready for re-inspection or desk review if additional evidence is required
Document lessons learned and update training programs

Conclusion:

A WHO PQP facility audit is a pivotal milestone for any pharma organization aspiring to supply to global health markets. Preparation must be strategic, collaborative, and focused on quality systems. By aligning with WHO expectations, training your people, and simulating inspections, you can not only pass the audit—but also build a robust compliance culture that supports sustained regulatory trust and global impact.