How to Maintain WHO PQP Status Over Time

How to Sustain WHO Prequalification Status Through Ongoing GMP Compliance

Achieving WHO Prequalification (PQP) is a significant milestone for pharmaceutical manufacturers—but sustaining it is an ongoing regulatory commitment. The WHO requires manufacturers to demonstrate continuous compliance with GMP, quality systems, and dossier maintenance throughout the product lifecycle. This guide outlines how to maintain WHO PQP status over time, with practical recommendations for inspection preparedness, post-approval variations, documentation updates, and risk mitigation strategies.

Understanding WHO PQP Lifecycle Obligations:

Post-approval monitoring by WHO and procurement agencies
Compliance with WHO GMP inspection outcomes and requalification timelines
Timely communication of changes and safety data
Participation in reinspection or documentation review cycles

1. Maintain a Robust GMP Compliance System:

Ensure continued alignment with WHO TRS 986 and TRS 961
Conduct internal GMP audits at least annually or per risk level
Track deviation trends and CAPA effectiveness with documented closure reports
Keep QC labs and manufacturing areas audit-ready through periodic housekeeping and SOP compliance checks

2. Keep All WHO-Submitted Documents Updated:

Document discrepancies between approved dossiers and on-ground practices are a major trigger for compliance action.

Align all SOPs with WHO-submitted formats and ensure version control
Update validation protocols and qualification reports for equipment or process changes
Ensure real-time updates in the Site Master File and quality manual
Maintain a change history tracker aligned with WHO PQ records

Also Read: Frameworks for Joint GMP Inspections by Multiple Regulatory Authorities

3. Monitor Stability Studies and Retest Data:

WHO expects ongoing stability monitoring for prequalified products to support shelf-life justification.

Ensure periodic analysis of real-time and accelerated batches
Update stability testing protocols in line with ICH Q1A(R2)
Revalidate stability indicating methods with any formulation or packaging changes
Submit updated stability summaries when filing variations or during requalification

4. Handle Variations According to WHO Guidelines:

Classify and manage variations as per WHO’s Variation Categorization Guidance
Submit prior approval variations (PAVs) for major changes in API source, manufacturing process, or specs
Notify WHO within specified timelines for minor changes or administrative updates
Document all change control records with risk assessments and QA approvals

5. Prepare for WHO Reinspections:

WHO may schedule reinspections every 3–5 years or based on risk indicators such as:

High procurement volume
Past critical observations or CAPA deficiencies
Introduction of new dosage forms or production lines
Complaint trends or post-market issues

Also Read: Differences Between WHO PQP and Stringent Regulatory Authority (SRA) Approvals

To remain inspection-ready:

Conduct mock audits using WHO TRS-based checklists
Retain all executed BMRs, logbooks, audit trails, and calibration reports
Ensure staff are trained on current procedures and emergency recall protocols

6. Submit Annual Reporting and Data Requests:

Respond promptly to WHO’s annual product review requests
Provide updated manufacturing and control records if required
Share pharmacovigilance and post-marketing safety updates
Report deviations that affect quality or supply under WHO communication guidelines

7. Implement Quality Metrics and Risk Management:

Proactive compliance hinges on performance tracking and mitigation planning.

Track batch rejection rates, audit findings, and CAPA closure timelines
Use quality indicators to prioritize internal audit scope
Identify GMP risks via FMEA or similar tools for critical systems
Maintain a supplier qualification system aligned with WHO TRS 986 Annex 6

8. Engage with WHO and Stakeholders Transparently:

Maintain open lines of communication with WHO PQP officers
Participate in technical update meetings or webinars hosted by WHO
Respond to donor agencies and procurement partner inquiries with WHO PQ references

Also Read: GMP Inspection Classifications: Routine, For-Cause, and Special Inspections

9. Ensure Product Traceability and Logistics Controls:

Distribution records, cold chain management, and product recall procedures must be validated and documented.

Maintain lot traceability across the supply chain
Validate transport conditions for temperature-sensitive products
Have a recall SOP tested through mock drills at least annually
Use digital systems for stock tracking and complaint logging

10. Train and Empower QA and Compliance Teams:

Update training programs based on regulatory trends and inspection learnings
Ensure QA oversight on every stage from incoming material to final product dispatch
Empower teams to escalate quality risks without fear of reprisal

Conclusion:

Maintaining WHO PQP status is a continuous journey anchored in GMP excellence, real-time documentation, and proactive engagement. By implementing systematic monitoring, managing post-approval changes effectively, and remaining inspection-ready, manufacturers can safeguard their prequalification and leverage it for long-term market access. WHO’s commitment to transparency and harmonization provides a strong framework—but it is the manufacturer’s responsibility to uphold it every day, across every batch and every facility.