How PIC/S Enhances GMP Compliance in Low- and Middle-Income Countries

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is widely recognized for harmonizing GMP standards globally. However, one of its most transformative roles is its support for GMP compliance in Low- and Middle-Income Countries (LMICs). These nations face unique challenges, including limited regulatory resources, varying infrastructure, and evolving pharmaceutical markets. This article examines the impact of PIC/S on GMP compliance in LMICs, covering training, harmonization, regulatory convergence, and long-term capacity building.

GMP Challenges Faced by LMICs

• Limited technical resources and trained inspectors
• Inconsistent enforcement of national GMP standards
• Infrastructure constraints in manufacturing and storage facilities
• Dependence on donor and international procurement systems (e.g., Global Fund, UNICEF)
• Regulatory fragmentation and weak legal frameworks

Why PIC/S Engagement Matters for LMICs

• PIC/S offers a globally harmonized framework for GMP inspection and compliance
• Participation supports regulatory maturity, inspector competency, and inspection consistency
• Acts as a gateway for alignment with WHO Prequalification Programme (PQP) standards
• Promotes international confidence in local manufacturing and import/export quality systems

Support Mechanisms Offered by PIC/S to LMICs

• Observer Status: Allows LMIC authorities to participate in meetings and training prior to full membership
• Inspector Training: Access to face-to-face and online training modules, covering:
  • Annex interpretation
  • Inspection techniques
  • Deficiency classification
  • Quality risk management
• Joint Inspections: Enables skill-building through cross-border inspection visits with experienced regulators
• Guidance Tools: Use of harmonized SOPs, aide-memoires, and standardized inspection formats

Collaboration with WHO and Donor Agencies

• PIC/S works alongside:
  • WHO Prequalification (PQP)
  • World Bank
  • USAID and Global Fund
• Supports regulatory convergence in initiatives like:
  • African Medicines Regulatory Harmonization (AMRH)
  • ASEAN regulatory forums
• Trains inspectors from LMICs to meet global inspection standards
• Encourages donor confidence in GMP compliance for locally manufactured essential medicines

Case Studies: PIC/S Impact in LMICs

• Tanzania: TMDA (now TMDA) benefited from WHO and PIC/S joint training, improving facility auditing practices
• Indonesia: BPOM enhanced GMP enforcement and is now progressing toward stronger mutual recognition capabilities
• Colombia and Nigeria: Observer roles in PIC/S allowed better alignment with international procurement expectations

Progression Path to PIC/S Membership

1. Gap Assessment: Conducted internally or with WHO technical assistance
2. Observer Status: Granted to authorities interested in learning and adapting PIC/S tools
3. Regulatory Strengthening: Development of legal and technical frameworks aligned with PIC/S
4. Membership Application: Subject to peer review and on-site evaluations
5. Full Membership: Enables participation in global harmonization efforts and joint inspections

Improving Inspection Capacity Through PIC/S

• Standardizes GMP audit practices for LMIC regulators
• Improves confidence in inspection outcomes through shared tools and templates
• Encourages knowledge transfer between mature and emerging authorities
• Strengthens accountability and enforcement capacity across pharmaceutical sectors

Impact on Local Manufacturers in LMICs

• Greater clarity on expectations for facility design, stability testing, documentation, and validation
• Prepares companies for donor inspections and international market access
• Improves quality culture and long-term sustainability of manufacturing operations
• Encourages investment by signaling regulatory commitment to global standards

Limitations and Barriers

• Financial and human resource constraints
• Regulatory fragmentation within countries or regions
• Political shifts and slow legislative reforms
• Need for long-term donor and stakeholder support

Recommendations for LMICs Engaging with PIC/S

1. Start with gap analyses using PIC/S and WHO benchmarking tools
2. Invest in long-term inspector training and capacity development
3. Use PIC/S guidance documents to align national GMP checklists and procedures
4. Engage stakeholders including donors, ministries of health, and local industry
5. Leverage pilot inspections, peer assessments, and observer missions

Conclusion

PIC/S plays a transformative role in raising the standard of GMP compliance in low- and middle-income countries. Through structured training, access to harmonized tools, and global collaboration, PIC/S empowers LMIC regulators to build stronger systems, inspire confidence, and protect public health. As LMICs continue to evolve, integrating PIC/S frameworks can be a game-changer in aligning with international pharmaceutical quality expectations and ensuring long-term regulatory sustainability.