Country Participation in WHO Joint Inspections: Strengthening GMP Oversight through Collaboration

As pharmaceutical manufacturing grows increasingly globalized, collaboration between international and national regulators has become essential. One of the most impactful strategies in this regard is country participation in WHO joint inspections. These inspections, conducted under the World Health Organization’s Prequalification Programme (PQP), enable national regulatory authorities (NRAs) to build capacity, harmonize GMP expectations, and streamline post-inspection decision-making. This article explores the framework, benefits, and operational procedures of WHO joint inspections involving NRAs.

What Are WHO Joint Inspections?

WHO joint inspections are collaborative GMP audits conducted by WHO inspectors in conjunction with representatives from participating NRAs. These inspections target manufacturing facilities applying for WHO prequalification or supplying donor-funded health programs.

Key Objectives of Joint Inspections:

• Facilitate regulatory convergence and reliance between WHO and NRAs
• Build technical capacity of NRA inspectors through real-time audit exposure
• Enable shared inspection reports and joint decisions for GMP compliance
• Support WHO’s vision of a harmonized global GMP framework

Eligibility and Participation Criteria:

• NRAs must be part of WHO’s Listed Authorities or demonstrate functionality
• Participation is voluntary but encouraged for countries hosting or procuring WHO-prequalified products
• Inspectors must have relevant GMP auditing experience and undergo WHO orientation

Structure of WHO Joint Inspections:

1. Planning and Coordination

• WHO identifies the inspection site and invites NRA participation
• A lead inspector (WHO) is designated, and national inspectors are briefed
• Common tools such as inspection checklists, TRS references, and report templates are shared

2. Pre-Inspection Preparation

Joint teams review the facility’s Site Master File, product dossier, previous inspection reports, and relevant SOPs. An inspection plan is drafted covering:

• Audit scope and areas of responsibility
• Duration and team structure
• Focus modules (e.g., QC lab, warehouse, stability studies, HVAC)

3. On-Site Inspection Execution

• Opening meeting with facility leadership and joint audit briefing
• Facility tour with risk-based walkthrough of manufacturing zones
• Traceability of batches, document reviews, deviation logs, and OOS investigations
• Review of stability testing programs and shelf-life justifications

4. Joint Observation Drafting

• Findings are compiled collaboratively with classification: Critical, Major, or Other
• Observation grading aligns with WHO TRS 986/961 standards
• CAPA expectations are aligned between WHO and the NRA

5. Closing Meeting and Report Development

• Joint presentation of findings to facility management
• WHO drafts the final inspection report with annexed contributions from NRA participants
• Both WHO and NRA retain a copy of the report for regulatory follow-up

Benefits of Joint Inspections for NRAs:

• First-hand exposure to WHO’s risk-based GMP inspection methodology
• Strengthening of national inspector competencies and audit consistency
• Recognition of joint inspections as a basis for national GMP certification
• Enhanced post-marketing surveillance and pharmacovigilance alignment

Benefits for Manufacturers:

• Reduced audit burden—one inspection recognized by multiple authorities
• Improved clarity on compliance expectations across markets
• Faster national registrations through reliance on WHO findings
• Less likelihood of conflicting CAPA requests

Countries Actively Participating in WHO Joint Inspections:

Countries across Africa, Southeast Asia, and Latin America have been part of WHO joint inspections, including India (CDSCO), Tanzania (TMDA), Ghana (FDA), Nigeria (NAFDAC), Indonesia (BPOM), and Brazil (ANVISA). These collaborations have helped align inspection outputs with national GMP certification programs.

Inspection Areas Typically Covered:

• Production and packaging lines
• Quality control laboratories
• Documentation systems and SOP adherence
• Material handling and traceability
• Stability chambers and validation protocols
• Cleaning validation and cross-contamination controls

Challenges in Joint Inspections:

• Language barriers or procedural differences between WHO and NRA teams
• Varying interpretation of GMP clauses
• Alignment of CAPA timelines and regulatory responsibilities
• Logistics of multi-agency coordination

Best Practices for Effective Joint Inspections:

1. Align expectations through pre-inspection teleconferences
2. Standardize observation documentation using WHO templates
3. Assign joint leads per module for consistency
4. Encourage open debriefing and cross-feedback sessions
5. Document joint conclusions in a harmonized report format

Long-Term Impact on Regulatory Systems:

Joint inspections serve as a foundation for establishing mutual recognition agreements (MRAs), regional regulatory harmonization, and participation in WHO-listed authorities (WLAs) framework. They promote trust, transparency, and shared accountability in GMP compliance across jurisdictions.

Conclusion:

Country participation in WHO joint inspections is a vital step toward a harmonized and globally connected pharmaceutical regulatory environment. By enabling shared learning, reducing duplication, and accelerating compliance decisions, these inspections not only benefit regulators and manufacturers—but ultimately protect patient safety through consistent, reliable GMP enforcement worldwide.