Why these 6 checks matter — industry context
India is the world's largest exporter of generic medicines by volume, with pharmaceutical exports reaching $27.9 billion in FY2024 (Pharmexcil, 2024). The country has over 500 WHO-GMP certified manufacturing facilities registered with CDSCO (CDSCO Annual Report, 2024-25). Of these, a significantly smaller subset operate the Grade A/B sterile cleanrooms required for injectable pharmaceutical manufacturing. International buyers — particularly in Africa, Middle East, CIS, and South-East Asia — face a verification challenge: many facilities claim WHO-GMP compliance without meeting the sterile manufacturing standards that export regulatory authorities specifically require. These six checks are the practical buyer's verification framework, drawn from the documentation requirements of NAFDAC (Nigeria), KEBS/PPB (Kenya), MOH UAE, SFDA (Saudi Arabia), and WHO prequalification guidelines.
All tests mandatory for batch release
Pharma-specific tests not mandated
