with EU GMP)

WHO TRS 986 Annexes 2, 3, 6

When a PIC/S member inspects a site, WHO PQP often accepts the findings if:

• The inspection scope matches the dosage form and process
• The report is current and verifiable
• The site addresses all cited CAPAs with documented evidence

Reduces duplication and speeds up approval for global procurement programs

Benefits for Pharmaceutical Manufacturers

• Streamlined Compliance: One inspection supports both regulatory and donor requirements
• Market Access: Facilities with PIC/S-recognized GMP can supply multiple international tenders
• Audit Efficiency: Less disruption from overlapping site inspections by WHO and donors
• Trust and Transparency: Enhanced reputation among global procurement networks

Use of PIC/S Reports in WHO PQP and Donor Submissions

1. Attach valid GMP certificate from a PIC/S member in Module 1.2 of the dossier
2. Include inspection report summary with:
   • Scope of audit
   • Deficiency classification
   • Corrective action timeline
3. Provide CAPA documentation cross-referenced to the inspection findings
4. Clarify that the facility and activity audited matches the application being submitted
5. If required, submit the full redacted report and follow-up correspondence with inspectors

Examples of PIC/S-Driven Recognition by Donors

• Antiretroviral manufacturer in South Africa: TGA GMP report used for WHO PQP acceptance
• Vaccine plant in India: EMA-PIC/S audit enabled Global Fund procurement eligibility
• Malaria API producer in China: Swissmedic GMP inspection supported UNICEF bulk award

Role of PIC/S in WHO Collaborative Registration Procedure (CRP)

• CRP allows national regulatory agencies to fast-track approval based on WHO or PIC/S evaluation
• PIC/S membership improves trust in shared GMP outcomes
• Helps smaller health authorities adopt inspection intelligence without duplicating resources

How Donor Agencies Use PIC/S for Quality Oversight

• Evaluate PIC/S member reports for risk assessment of suppliers
• Use shared reports to plan targeted surveillance and follow-up audits
• Set supplier eligibility criteria requiring inspection by PIC/S or WHO PQP
• Build global databases tracking GMP history and compliance status

Support for LMIC Regulatory Authorities

• PIC/S helps strengthen national systems through:
  • Inspector training programs
  • Joint inspection participation
  • SOP standardization aligned with PIC/S templates
• Authorities in transition to PIC/S can still benefit from PQP-linked inspection collaboration
• Promotes long-term sustainability of quality assurance infrastructure in LMICs

Opportunities for Further Integration

1. Develop joint inspection scheduling platforms between PIC/S and PQP
2. Digitize GMP certificate validation via secure global registry
3. Encourage joint capacity-building programs for local inspectorates
4. Harmonize inspection formats, especially for SOP compliance and risk-based surveillance
5. Foster greater industry awareness on leveraging PIC/S for global access pathways

Conclusion

PIC/S is a cornerstone of global GMP harmonization, and its collaboration with WHO PQP and donor agencies enhances access to quality-assured medicines across borders. Through mutual recognition, shared inspection models, and capacity building, PIC/S enables regulatory and procurement stakeholders to operate with efficiency, transparency, and confidence. For manufacturers and regulators alike, understanding and leveraging this alignment is essential for scaling access to safe and effective pharmaceuticals globally.