By the PharmaTradz BD Team. Published October 2026.
A WHO-GMP certificate is an official document confirming that a pharmaceutical manufacturing site complies with Good Manufacturing Practice as defined by the World Health Organization. Despite the name, it is not issued by WHO. It is issued by the medicines regulator of the country where the factory is located, against WHO's GMP standard and in support of the WHO Certification Scheme, after that regulator has inspected the site. For importers in much of Africa, Asia, Latin America and the Middle East, it is usually the first document requested from a new supplier.
That last point is worth repeating, because it is the source of most confusion. WHO does not certify factories for trade. When a supplier says it is "WHO certified", what it normally means is that its own national regulator has certified it against WHO's GMP standard.
What the certificate says
A WHO-GMP certificate typically states the name and address of the manufacturing site, the dosage forms or product categories it covers, the date of the most recent inspection, the standard it was inspected against, and the issuing authority with a certificate number and date. Some certificates list individual products; others cover categories of manufacturing, such as tablets or sterile injectables. The scope matters: a certificate covering oral solids says nothing about the same company's injectable line.
Who issues it in India
In India, WHO-GMP certificates are issued jointly by the Central Drugs Standard Control Organisation (CDSCO) and the State Licensing Authority, normally after a joint inspection of the site against WHO GMP and India's revised Schedule M. The same system issues the Certificate of a Pharmaceutical Product (CoPP) for individual products made at a certified site. Certificates are revalidated over time, so always look at the issue date and the date of the last inspection.
WHO-GMP certificate versus WHO prequalification
These are very different things. A WHO-GMP certificate is issued by a national regulator. WHO prequalification is WHO's own programme: WHO assesses the product dossier and inspects the site itself, and prequalified products are listed publicly. Prequalification, or approval by a stringent regulatory authority, is required for many medicines bought by UN agencies and global health programmes, and it is far harder to obtain than a national certificate. A supplier with a WHO-GMP certificate is not prequalified unless its product appears on WHO's prequalification list.
What a WHO-GMP certificate does, and does not, prove
It shows that the national regulator inspected the site and found it compliant with WHO GMP at the time of inspection. That is valuable, and for many importing countries it is exactly what registration requires.
It does not show that the site meets EU or US requirements, which have their own inspections. It does not cover products or dosage forms outside its scope. And it does not, on its own, prove anything about a particular batch; that is the job of the API and product documents, including the Certificate of Analysis for each batch. Our article on which certifications actually matter compares WHO-GMP with US FDA and EU GMP approvals.
How to check a certificate is genuine
Forged and expired GMP certificates do circulate in international trade, so a few minutes of checking is time well spent.
Make sure the name and address on the certificate match the factory on the supplier's invoices, labels and CoA. A certificate for a different site, or for a parent company rather than the plant, is a warning sign.
Check the dates and scope: when the site was last inspected, whether the certificate has been revalidated, and whether it covers the dosage form you are buying.
Then confirm it with the issuing authority, using contact details you find yourself rather than ones supplied by the seller. Our step-by-step guide to identifying a genuine WHO-GMP certified manufacturer walks through the process, and our supplier verification guide covers the other documents.
More document explainers
The documents in a supplier's quality pack work together. See also what a DMF (Drug Master File) is, how to read a Certificate of Analysis, what a CoPP is and how importers use it and GMP vs cGMP.
How PharmaTradz can help
We ask manufacturers for their GMP certificates and inspection status before we introduce them, and we can tell you whether a site's approvals fit your destination market. Our documentation and quality pack brings the WHO-GMP certificate, CoPP and CoA together in one place. When you are ready, send us an RFQ, or if you are a manufacturer, list your site and approvals to reach buyers.
Frequently Asked Questions(FAQs)
Who issues a WHO-GMP certificate?
The medicines regulator of the country where the factory is located, against WHO's GMP standard. WHO itself does not issue GMP certificates for trade.
Who issues WHO-GMP certificates in India?
CDSCO and the State Licensing Authority issue them jointly, normally after a joint inspection of the site against WHO GMP and India's revised Schedule M.
Is a WHO-GMP certificate the same as WHO prequalification?
No. A WHO-GMP certificate comes from a national regulator. WHO prequalification is WHO's own assessment and inspection of a specific product, listed publicly on WHO's prequalification website.
Does a WHO-GMP certificate allow export to the EU or US?
No. The EU and US require their own GMP inspections or recognised equivalents. A WHO-GMP certificate is mainly used for registration in markets that rely on the WHO Certification Scheme.
How do I check that a WHO-GMP certificate is genuine?
Match the site name and address with the supplier's other documents, check the dates and scope, and confirm the certificate number directly with the issuing authority using contact details you find yourself.
