Cross-Agency Coordination in WHO Inspections: Strengthening Global GMP Synergy

In today’s interconnected pharmaceutical landscape, effective oversight demands coordination beyond individual agencies. The World Health Organization (WHO), through its Prequalification Programme (PQP), spearheads cross-agency coordination in GMP inspections to harmonize standards, reduce redundancies, and strengthen compliance mechanisms globally. This article explores how WHO collaborates with national regulatory authorities (NRAs), regional bodies, and international stakeholders to conduct unified GMP audits and streamline regulatory convergence.

Why Cross-Agency Coordination Matters in GMP Inspections:

• Reduces inspection duplication and industry audit fatigue
• Promotes mutual trust and regulatory reliance across countries
• Builds inspection capacity in low- and middle-income countries (LMICs)
• Accelerates access to quality-assured medicines and vaccines

WHO’s Framework for Cross-Agency Engagement:

WHO operates under a regulatory convergence framework that encourages cooperation with NRAs, Stringent Regulatory Authorities (SRAs), and regional networks such as the Pan American Network for Drug Regulatory Harmonization (PANDRH), African Medicines Regulatory Harmonization (AMRH), and ASEAN.

Key WHO Strategies for Cross-Agency GMP Coordination:

1. Joint Inspections with NRAs

• WHO invites national inspectors to join PQP audits of facilities in their jurisdiction
• Facilitates skill sharing, observation standardization, and collaborative decision-making
• Outcome reports are shared and acknowledged by both parties

2. Reliance on SRA Inspection Outcomes

• WHO accepts GMP audits from SRAs such as USFDA, EMA, and PMDA under defined equivalence models
• Minimizes redundancy for manufacturers with existing SRA certifications
• Focuses WHO resources on high-risk or uninspected sites

3. Regional Inspection Partnerships

• WHO supports joint inspections organized by African Medicines Regulatory Harmonization (AMRH) and East African Community (EAC)
• Enhances GMP alignment across regional blocs
• Utilizes harmonized tools such as WHO TRS checklists and CAPA templates

Typical Flow of a WHO-Coordinated Joint Inspection:

1. Site Selection and Scope Definition

• Manufacturer applies for PQ or triggers audit via CRP or variation
• WHO proposes joint inspection to national or regional regulators
• Scope and timelines are aligned across all participating agencies

2. Pre-Inspection Briefings

• Virtual or in-person meetings to align on GMP priorities and expectations
• Review of previous inspection reports, SOPs, and variation history
• Division of audit responsibilities (e.g., production, QC, data integrity)

3. On-Site Execution and Joint Reporting

• Combined walkthroughs of facility zones and document review
• Joint interviews with QA, QC, and manufacturing personnel
• Drafting of harmonized observation reports using WHO terminology
• Consolidated feedback shared during the closing meeting

4. Follow-Up and CAPA Monitoring

• Coordinated review of CAPA responses by WHO and participating regulators
• Mutual recognition of corrective action adequacy
• Harmonized timelines for closure and public reporting

Benefits of Cross-Agency GMP Audits:

• Single inspection recognized across multiple regulatory jurisdictions
• Faster procurement approvals via CRP and national registrations
• Alignment of GMP expectations for global supply chain players
• Cost savings and reduced disruption for manufacturers

Roles of Key Stakeholders:

1. WHO PQP

• Leads inspection planning and documentation
• Maintains regulatory frameworks and SOP templates
• Issues final GMP compliance statements

2. National Regulatory Authorities (NRAs)

• Nominate qualified GMP inspectors
• Co-review findings and participate in decision-making
• Use inspection results to support national product registration

3. Manufacturers

• Provide access to facilities and documentation
• Engage with inspectors across multiple agencies
• Respond to consolidated CAPA expectations

Challenges in Multi-Agency GMP Coordination:

• Variability in GMP interpretation and enforcement practices
• Language barriers and procedural differences
• Discrepancies in document expectations (e.g., SOP formats, batch record styles)
• Need for synchronized follow-up and regulatory actions

Best Practices for Effective Coordination:

1. Establish pre-inspection agreements on terminology and classification
2. Use harmonized checklists aligned with WHO TRS 986
3. Define joint CAPA formats and closure timelines in advance
4. Include virtual participation options for remote agencies
5. Document lessons learned and inspection harmonization outcomes

Conclusion:

Cross-agency coordination in WHO inspections represents a paradigm shift toward regulatory convergence and efficiency. By leveraging joint audits, WHO and its partners not only optimize global GMP compliance efforts but also accelerate the delivery of life-saving medicines to the world’s most vulnerable populations. For manufacturers and regulators alike, engaging in collaborative inspections is both a strategic and ethical imperative in the pursuit of global health equity.