What Is WHO-GMP Certification and Why It Matters for Buyers

Good Manufacturing Practice (GMP) is a system that ensures pharmaceutical products are consistently produced and controlled to quality standards appropriate to their intended use. WHO-GMP refers to the GMP guidelines published by the World Health Organization. A WHO-GMP certificate, issued by a national regulatory authority following inspection, confirms that a manufacturing facility complies with these standards, covering areas such as premises, equipment, personnel, documentation, quality control, and production processes.

For a buyer, WHO-GMP certification provides assurance that the medicines you import are manufactured under controlled, quality-assured conditions. It is also frequently a practical requirement: many national regulatory authorities require evidence of WHO-GMP compliance as part of product registration, and many tenders and procurement programmes require it as a condition of participation. Sourcing from a WHO-GMP certified manufacturer reduces regulatory and quality risk.

These two are often confused but are different. WHO-GMP certification confirms a facility meets GMP standards. WHO Prequalification (WHO-PQ) is a separate, product-specific assessment in which the WHO evaluates a particular medicine, including its quality, safety, efficacy, and the manufacturing site, against stringent standards. WHO-PQ is generally more rigorous and is often required for medicines procured through international donor-funded programmes such as the Global Fund. A manufacturer can be WHO-GMP certified across its facility, with specific products additionally holding WHO Prequalification.

When evaluating a manufacturer, ask to see the current WHO-GMP certificate and confirm it covers the relevant facility and dosage forms. For donor-funded procurement, ask whether the specific product holds WHO Prequalification. Confirm the manufacturer can provide a Certificate of Pharmaceutical Product (CoPP) and the regulatory dossiers required for registration in your market.

BioGalen Pharmaceuticals manufactures its generic medicines in a WHO-GMP certified facility in Gujarat, India, and provides CTD and ACTD dossiers and regulatory support for registration in importing markets. Explore our product catalogue, learn how to import generic medicines from India, or request a quote.