WHO PQP GMP Certification vs. Local GMP Certification

WHO PQP GMP Certification vs. Local GMP Certification: Key Distinctions for Global Market Access

Good Manufacturing Practice (GMP) certification is a critical requirement for pharmaceutical manufacturers. While national GMP certifications enable local operations, WHO Prequalification Programme (PQP) GMP certification serves as a global benchmark. Understanding the difference between WHO PQP GMP and local GMP certification is vital for pharmaceutical professionals navigating compliance, international procurement, and market expansion.

1. Purpose and Regulatory Jurisdiction:

WHO PQP GMP Certification

Issued by WHO as part of its Prequalification Programme (PQP)
Applies to manufacturers supplying medicines to global health organizations
Focuses on ensuring quality, safety, and efficacy of essential medicines
Recognized globally by UN agencies and procurement bodies

Local GMP Certification

Issued by a country’s National Regulatory Authority (NRA)
Mandatory for marketing pharmaceutical products within the country
Compliance standards may vary by region (e.g., Schedule M in India, TGA in Australia)
Valid only within the jurisdiction of the issuing authority

2. Inspection Standards and Guidelines:

WHO PQP GMP

Based on WHO Technical Report Series (TRS) 986 and 961
Incorporates principles of ICH Q7, Q8, Q9, and Q10
Assesses full quality systems, stability programs, risk management, and data integrity
Focus on risk-based inspections aligned with product type and global public health needs

Also Read: Evolution of International GMP Inspection Standards and Practices

Local GMP

May follow local GMP frameworks such as India’s Schedule M or country-specific adaptations of PIC/S
Not always harmonized with WHO or ICH guidelines
Inspections may focus more on documentation and basic infrastructure
In some cases, enforcement and oversight resources may be limited

3. Scope of Evaluation:

WHO PQP GMP

Comprehensive, includes production, packaging, QC, validation, QMS, and post-marketing practices
Focused on facilities manufacturing products for HIV, TB, malaria, reproductive health, etc.
Assesses SOPs, batch records, analytical methods, and CAPA systems

Local GMP

Often limited to regulatory checklists and routine manufacturing protocols
Focus may be more on infrastructure and less on risk management or global harmonization
May not evaluate full product lifecycle or supply chain management

4. Recognition and Strategic Use:

WHO PQP GMP

Mandatory for participation in Global Fund, UNICEF, UNDP, and GAVI procurements
Serves as a gateway to Collaborative Registration Procedure (CRP) in over 30 countries
Boosts credibility with Stringent Regulatory Authorities (SRAs)

Also Read: Key Differences Between US, EU, and WHO Inspection Approaches

Local GMP

Required for national marketing authorization and manufacturing license
May be accepted regionally (e.g., SADC, ASEAN, EU mutual recognition)
Generally not recognized for international tenders or global procurement

5. Inspection Process and Timeline:

WHO PQP GMP

Risk-based inspection scheduling depending on product category and prior history
Joint inspections with NRAs and external experts
Typically lasts 4–5 days with in-depth reviews of critical systems
CAPA responses expected within 60 days post-inspection

Local GMP

Scheduled periodically or upon license renewal/application
Duration and depth may vary significantly
CAPA timelines can range from 30 to 90 days depending on country

6. Documentation and Evidence Requirements:

WHO PQP audits require complete traceability in data, validated cleaning, and robust quality metrics
Emphasis on data integrity, risk-based control strategies, and continual improvement
Local inspections may require a narrower scope of documentation
Global procurement organizations may reject products with local GMP alone

Also Read: Understanding WHO’s Risk-Based Inspection Model

7. Post-Certification Monitoring:

WHO PQP

Subject to reinspection every 3–5 years
Annual Product Review (APR) submissions required
Variations must be reported and approved through WHO’s variation classification system

Local GMP

Re-certification timelines and requirements depend on local policy
Post-approval changes may not require prior approval in some regions
Enforcement may vary based on the strength of the NRA

Strategic Implications for Manufacturers:

WHO PQP GMP certification is vital for manufacturers aiming for international supply
It improves global recognition, reduces inspection duplication, and supports reliance models
Local GMP is necessary for national operations but insufficient for global competitiveness
Dual certification (local + WHO PQP) enhances both domestic and international market access

Conclusion:

While local GMP certification enables domestic legitimacy, WHO PQP GMP certification is the passport to international quality recognition and procurement eligibility. Understanding their differences in scope, rigor, and strategic impact helps manufacturers align with global health goals while meeting country-specific compliance requirements. For forward-looking pharmaceutical companies, integrating both certifications into a unified quality strategy is not just regulatory—it’s transformational.