WHO GMP Explained: What the Certificate Proves for US Buyers

WHO GMP is good manufacturing practice guidance written by WHO. A WHO GMP certificate is a site-level GMP certificate issued by a national or state regulator, often as part of a CPP application under the WHO Certification Scheme, or in WHO's model format, which is outside that Scheme. WHO itself does not issue it.

GMP exists because testing the finished product cannot remove every risk from a poorly controlled process. WHO's explanation of GMP describes it as designed to minimize the risks that final testing cannot eliminate. For finished pharmaceutical products, the main text is WHO Technical Report Series (TRS) 986, Annex 2 (2014). For APIs, WHO's GMP standard is TRS 957, Annex 2 (2010), "WHO good manufacturing practices for active pharmaceutical ingredients (bulk drug substances)"; TRS 986 Annex 2 covers finished products.

The guidance is not law by itself. More than 100 countries have written WHO's GMP provisions into national medicines laws, and more follow its approach in their own rules. WHO also runs a separate prequalification program for UN procurement, which is a different route from the certificate a supplier shows you.

The first route is the WHO Certification Scheme, a voluntary agreement in operation since 1969. A participating country's authority attests that a manufacturing site is inspected at suitable intervals against WHO-recommended GMP, usually as part of a CPP. The second is WHO's model GMP certificate, covered below, which a regulator can issue on its own. In India, CDSCO publishes lists of certified units compiled from returns by the states and union territories.

No. A site GMP certificate covers a manufacturing site. A CPP covers one product. A batch certificate or certificate of analysis (COA) covers one batch. A supplier can hold one of these documents and be unable to provide any of the others.

WHO's model GMP certificate is a suggested template for importers, procurement agencies and regulators that ask for a site-specific certificate. It is not part of the Scheme. It stays valid for two years from issue and never beyond three years after the inspection.

The CPP is written for finished products: its model asks for the unit formulation, including all excipients. If you buy an API, ask for the site certificate and the batch COA instead.

Not by itself. A WHO GMP certificate comes from the exporting country's regulator, while FDA applies its own current good manufacturing practice (CGMP) requirements and inspects facilities worldwide, including those making active ingredients. For US sourcing, treat the certificate as supporting evidence and qualify the site yourself.

The "C" in CGMP stands for "current", meaning companies must use up-to-date technologies and systems. For APIs, the working standard is ICH Q7, which FDA publishes as Q7 for APIs used in human drug products.

As of FDA's 3 August 2026 report, its India office completed 139 inspections in fiscal year 2025, 47% unannounced, and 76 in fiscal year 2026 to date, 87% unannounced.

Our recommendation: ask any supplier for the site's FDA establishment identifier (FEI), the unique number FDA uses to assign, monitor and track inspections of a firm, and the date of its last FDA inspection. Do this before relying on any "FDA compliant" wording.

CDSCO's list dated 31 December 2025, released 17 June 2026, shows 3,582 certified units across 26 states and union territories, and Gujarat alone accounts for 1,729. It is a cross-check, not proof: a listing does not show that any single certificate is current, so confirm with the issuing authority.

We counted on 4 October 2026, using the 31 December 2025 PDF linked from CDSCO's Industry Miscellaneous page. The sample is the full 373-page file. Our row-level parse recovered 3,482 entries, fewer than the 3,582 in the state totals, so row-level figures below are approximate.

• Total: the state table sums to 3,582 units across 26 states and union territories with entries. Ten more are listed as nil. The printed totals for Goa (48) and Maharashtra (536) include 189 loan-license manufacturers (10 and 179).
• Concentration: Gujarat holds 1,729 of the 3,582 (48.3%, from 1,729 ÷ 3,582). Maharashtra has 536, Himachal Pradesh 273, Telangana 233 and Uttarakhand 166 (4.6%).
• Uttarakhand: the state's total was 104 on the list as received from the States and UTs as on February 2015 (1,329 units in all), and 36 on CDSCO's January 2023 to March 2024 list. A state's absence or a drop reflects what it submitted to CDSCO, not a verdict on its plants (our inference). None of the 161 Uttarakhand rows we parsed names an API or bulk drug in its permitted category.
• Dates: the list now has a validity column. Of the 3,482 rows we parsed, 3,112 carry a readable date. Formats mix day-first and month-first, so we compared each row's latest date with 4 October 2026 under both readings: at least 268 rows show a date before that day under either reading, 2,259 show a later date under either reading, and 585 depend on the reading. The other 370 rows carry no readable date.
• Scope: matching "bulk drug" (case-insensitive, whitespace-tolerant) on text extracted from the PDF gave 747 matches as of 4 October 2026; this counts category mentions, not distinct sites. Some entries label the category "API" or "APIs" instead and are not in that count.

As of 15 July 2025, Indian manufacturers apply for a WHO-GMP certificate of pharmaceutical product (COPP) only through CDSCO's Online National Drugs Licensing System (ONDLS) portal.

Our reading: a name on this list is a useful lead, and a missing name means little. Neither replaces a dated certificate copy confirmed by the issuing authority.

Run seven checks in order: issuer, site, scope, dates, authority confirmation, document type and US standing. Each has a pass and a fail. A supplier that passes all seven has given you evidence worth taking into an audit. A failure on steps one to four should stop the order until it is explained.

What can you send a supplier to run all seven checks at once?

Replace [number] with the CAS number, the Chemical Abstracts Service registry number that identifies a substance.

Subject: Document request: [product], CAS [number], destination [country]

Please send:
1. The GMP certificate for the site that manufactures this material,
   showing issuing authority, issue date and validity.
2. The site's full address as printed on the certificate.
3. The permitted category on the certificate.
4. The site's FDA establishment identifier (FEI) and the date of its
   last FDA inspection, if any.
5. The COA for the current batch and the specification.
6. Confirmation of which site makes, tests and releases the batch.

Send us the product name or CAS number, quantity, destination, grade or purity, the documents you need, payment terms and Incoterms (international shipping terms). Before we quote, we confirm which documentation applies to that product, its manufacturing source and your destination.

We are an India-based API supplier, sourcing partner, distributor and exporter serving pharmaceutical companies, importers and other B2B buyers. The certificate you need is the one for the site that makes your batch, and we supply from approved manufacturing sources. Available documents may include a COA, specifications and a safety data sheet (SDS/MSDS) where applicable. We support sample and evaluation quantities for qualified B2B buyers, with quantity, price and documents confirmed product by product.

Aarise does not provide a drug master file (DMF), CPP or certificate of suitability (CEP) for steroid APIs. We support documentation and supply for US importers; send the request above and we will say which documents exist for your product. The seven checks apply to us as to any supplier.

Some materials are restricted, controlled or need special import authorization in certain jurisdictions. Before commercial supply, confirm local registration, import authorization and permitted end use, and tell us your destination first.

Request a quotation and documentation list, or reach our sales team at sunil@aarisepharma.com or on WhatsApp at +91 9899783330.