World Health Organization GMP certification — the global baseline for pharmaceutical manufacturing quality.
WHO PQ program opens doors to UNICEF, GFATM, and UN procurement
Over 120 Pakistani manufacturers hold some form of WHO GMP certification
Manufacturers of WHO essential medicines are prioritized for certification
WHO GMP recognized across Africa, Asia, Latin America markets
WHO GMP (Good Manufacturing Practice) guidelines — TRS 986 Annex 2 — represent the international baseline standard for pharmaceutical manufacturing quality. WHO GMP is widely recognized in developing and emerging markets including most of Africa, Central Asia, Southeast Asia, and Latin America. Pakistan's DRAP issues WHO GMP certificates to qualifying manufacturers following satisfactory inspection.
The WHO Prequalification Programme (WHO PQ) is separate from but related to WHO GMP. WHO PQ approval enables Pakistani manufacturers to supply medicines procured by UNICEF, the Global Fund (GFATM), PEPFAR, and other international health agencies. This is a highly prized certification that significantly expands market access. The assessment covers product dossier review, site inspection, and product sampling/testing.
Pakistani manufacturers can obtain a WHO GMP certificate from DRAP following an inspection conducted against WHO GMP standards. The process involves application submission, document review, facility inspection, deficiency rectification, and certificate issuance. Certificates are valid for a defined period and are subject to surveillance inspections. Companies may also engage international inspection bodies for additional WHO GMP verification.