standards.

Non-Compliance Report: Document issued when audit observations highlight major deficiencies.

Reliance and Recognition Models: Regulatory acceptance of WHO PQ certifications to reduce duplicate inspections.

These definitions highlight the role of WHO PQ and ROW audits in maintaining global regulatory trust.

WHO PQ Audit Process

The WHO PQ audit process typically includes:

1. Application: Manufacturer submits dossier for prequalification review.
2. Dossier Assessment: WHO evaluates product quality, safety, and efficacy data.
3. GMP Inspection: WHO auditors inspect manufacturing facilities for GMP compliance.
4. CAPA Submission: Manufacturer provides corrective action plans for deficiencies.
5. Re-Inspection (if required): Verification of CAPA implementation.
6. Prequalification: Product listed on WHO PQ database after approval.

Once approved, WHO PQ-listed products gain eligibility for UN procurement tenders and are trusted by many ROW regulators.

ROW Audit Process

ROW audits vary across countries but generally follow this workflow:

1. Notification: Local regulatory authority announces an inspection or audit.
2. Preparation: Company reviews SOPs, quality systems, and site readiness against national GMP guidelines.
3. On-Site Inspection: Facility tour, documentation review, and staff interviews.
4. Observations: Inspectors document deficiencies and classify them as critical, major, or minor.
5. Response: Manufacturer submits CAPA plans to the authority within specified timelines.
6. Follow-Up: Verification of compliance improvements in subsequent audits.

ROW audits often mirror WHO PQ expectations but include country-specific requirements such as language, labeling, or pharmacovigilance practices.

Case Study 1: WHO PQ Audit for Antimalarial Drug

Case: In 2022, a manufacturer in India applied for WHO PQ for an antimalarial product.

• Challenge: Audit revealed deficiencies in cleaning validation and stability data reporting.
• Action: Company performed retrospective validation, updated SOPs, and enhanced stability protocols.
• Outcome: WHO PQ granted after follow-up inspection confirmed compliance.
• Lesson Learned: Stability and cleaning validation are recurring focus areas in WHO PQ audits.

Case Study 2: ROW Audit in Brazil

Case: ANVISA conducted a ROW audit in 2023 at a vaccine manufacturing facility.

• Challenge: Observations included inadequate training documentation and incomplete environmental monitoring records.
• Action: Company introduced electronic training systems and enhanced monitoring procedures.
• Outcome: Compliance restored within six months, enabling product approval in Brazil.
• Lesson Learned: Training and environmental controls are top priorities for ROW regulators.

Tools, Templates, and Systems for Audit Preparation

Effective preparation for WHO PQ and ROW audits includes:

• WHO TRS Guidelines: Use WHO Technical Report Series (TRS) as a baseline for compliance.
• Audit Checklists: Structured templates covering facility, documentation, and QMS readiness.
• QMS Platforms: Systems like Veeva, TrackWise, and MasterControl to manage deviations, CAPA, and training records.
• Mock Audits: Internal or consultant-led audits simulating WHO and ROW inspections.
• Regulatory Intelligence Tools: Monitoring WHO PQ updates and ROW regulatory changes.

These resources ensure readiness and reduce risks of non-compliance findings.

Common Challenges and Best Practices

Companies face recurring challenges in WHO PQ and ROW audits:

• Documentation Gaps: Incomplete SOPs, batch records, or stability reports.
• Training Deficiencies: Staff unable to demonstrate knowledge of GMP responsibilities.
• Delayed CAPA Implementation: Slow corrective actions undermine credibility with auditors.
• Regional Variations: Country-specific requirements often overlooked in global strategies.

Best practices include conducting regular mock audits, integrating CAPA with QMS, aligning training with inspection priorities, and developing country-specific regulatory readiness plans.

Latest Updates and Strategic Insights

By 2025, WHO PQ and ROW audit trends include:

• Reliance Models: Countries increasingly accept WHO PQ as a benchmark for national approvals.
• Hybrid Audits: Mix of remote and on-site inspections continuing post-pandemic.
• Digital QMS: Regulators expect digital systems for documentation, training, and audit trails.
• Supply Chain Oversight: Expanded focus on vendor audits and raw material traceability.
• AI-Powered Audits: Early adoption of AI analytics by regulators to identify risk patterns.

Strategically, companies should align with WHO PQ requirements, maintain inspection readiness across facilities, and adapt to digital and hybrid audit expectations.

Conclusion

WHO PQ and ROW audits are vital for maintaining global regulatory trust and market access. By aligning with WHO TRS guidelines, conducting robust mock audits, and addressing region-specific requirements, companies can strengthen inspection readiness and sustain compliance. In 2025 and beyond, proactive audit management and digital QMS adoption will be key to success in global markets.