What is WHO-GMP certification? Who issues it, what it covers and how buyers verify it

“WHO-GMP certified” appears on a great many Indian supplier websites, and buyers outside India often read it as a WHO approval. It is not. A WHO-GMP certificate is issued by a national regulator, which certifies that a site follows the good manufacturing practice guidelines that WHO publishes. That is useful information, but it is a different thing from WHO prequalification, EU GMP or FDA compliance.

This guide explains what WHO GMP is, how the WHO Certification Scheme and the Certificate of Pharmaceutical Product (COPP) work, who issues WHO-GMP certificates in India, how India’s revised Schedule M fits in, and how a buyer can check a certificate before relying on it. It is written for buyers of peptide APIs, contract lyophilization and fill-finish. Supplier qualification more broadly is covered in how to qualify a peptide API supplier.

What is WHO GMP?

WHO defines GMP as “the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification” [1]. WHO GMP is a set of written guidelines adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations and published in the WHO Technical Report Series (TRS).

The history explains the link with certification. The first WHO draft text on GMP was prepared in 1967 at the request of the Twentieth World Health Assembly (resolution WHA20.34) [2]. In 1969, when the World Health Assembly recommended the first version of the WHO Certification Scheme in resolution WHA22.50, “it accepted at the same time the GMP text as an integral part of the Scheme”; revised versions of both were adopted in 1975 by resolution WHA28.65 [2]. WHO reports that “more than 100 countries have incorporated the WHO GMP provisions into their national medicines laws” [1].

The key WHO GMP texts for peptide and sterile manufacturing are:

WHO text	What it covers	Notes
TRS 986, Annex 2 (2014)	Main principles of GMP for pharmaceutical products	Revision of TRS 961, Annex 3 (2011) [2]
TRS 1044, Annex 2 (2022)	GMP for sterile pharmaceutical products	Revision of TRS 961, Annex 6 (2011), prepared with the EU and PIC/S [3]
TRS 1033, Annex 9 (2021)	Guidelines on implementing the WHO Certification Scheme	Includes the model Certificate of Pharmaceutical Product [4]

WHO’s 2022 sterile text tracks the EU’s revised Annex 1: PIC/S describes the Annex 1 revision as driven by PIC/S and the EMA inspectors’ working group “in close co-operation with the European Commission (EC) and the World Health Organization (WHO)” [5] [3]. Our EU GMP Annex 1 guide covers the shared requirements.

What does WHO GMP cover?

The main principles in TRS 986 Annex 2 are organised in 17 sections: pharmaceutical quality system (including quality risk management and product quality review); good manufacturing practices; sanitation and hygiene; qualification and validation; complaints; product recalls; contract production, analysis and other activities; self-inspection, quality audits and suppliers’ audits; personnel; training; personal hygiene; premises; equipment; materials; documentation; good practices in production; and good practices in quality control [2].

The text states that “GMP is concerned with both production and QC” and is “aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products” [2]. Two clauses in the contract section matter for anyone buying outsourced work. Contract manufacture “may be undertaken only by a manufacturer who holds a valid manufacturing authorization”, and the contract acceptor “should not pass to a third party any of the work entrusted to him or her under the contract without the contract giver’s prior evaluation and approval of the arrangements” (7.11) [2]. Product-specific annexes, such as the 2022 sterile text, add requirements on top of these principles [3].

Who issues “WHO-GMP” certificates?

National regulators do. The WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce is “an international voluntary agreement to provide assurance to countries participating in the Scheme about the quality of pharmaceutical products moving in international commerce”, and “the primary document of the Scheme is the certificate of a pharmaceutical product (CPP)” [6].

WHO’s implementation guidelines describe the Scheme as “an administrative instrument that requires each participating Member State or regional authority, upon application by a commercially interested party, to attest to the competent authority of another participating Member State” that a product is authorised for sale and that “the manufacturing site is subject to inspections at suitable intervals to establish that the manufacturer conforms to GMP” as recommended by WHO [4]. The Scheme has operated since 1969 and was amended in 1975, 1988, 1992 and 1997 [4]. The certifying authority, not WHO, must be satisfied that manufacture complies “with GMP as recommended by WHO” before it attests to it [4].

Three features of the CPP matter to buyers:

• It is product-specific. The model certificate asks whether the certifying authority “arrange[s] for periodic inspection of the manufacturing site” and when the manufacturer was last inspected [4].
• It is confidential. “The certificate is a confidential document which may be issued by the certifying authority only with the permission of the applicant or of the marketing authorization holder” [4].
• It can be verified. “When any doubt arises about the status or validity of a certificate, the requesting authority should request verification of the validity of the certificate from the certifying authority” [4].

How WHO-GMP certification works in India

India joined the Scheme decades ago. The Maharashtra Food and Drug Administration’s guidelines record that the Drugs Controller of India informed WHO of India’s participation and that the 20th meeting of the Drugs Consultative Committee, held in New Delhi on 4 and 5 July 1978, decided that “joint inspection of manufacturing firms by the officers of the State Drugs Control Organization and Zonal Officer from Central Drugs Standard Control Organization should be carried out before issuing certificates under the Scheme” [7].

That joint model continues. CDSCO’s 2024 guidance for its zonal and sub-zonal offices lists, as their first technical function, “to scrutinize the application and participate in the joint inspection for issuance /revalidation of Certificate of Pharmaceutical Products (COPPs) as per WHO certification scheme” [8]. The same document notes that the inspection checklist is “primarily prepared on the basis of provisions of Schedule M” and that inspectors should adopt it “as per the current applicable WHO GMP Guidelines in case of inspection for issuance of COPPs” [8].

The certificate itself is issued by the state’s certifying authority. In Maharashtra, the certifying authority is the Joint Commissioner (HQ) of the state FDA, which may issue three documents on request: Certificates of Pharmaceutical Product, a Model Statement of Licensing Status, and a “Unit WHO GMP Certificate along with the list of products for which Certificate of Pharmaceutical Products have been granted” [7]. Maharashtra’s guidelines state that “the validity of certificates shall be two years from the date of grant” [7]. Other states publish their own procedures, so validity and format should be checked on each certificate.

Step	Who	What happens
Application	Manufacturer	Applies to the state certifying authority with product and site documents [8] [7]
Document scrutiny	CDSCO zonal/sub-zonal office	Screens the COPP (WHO-GMP) application against a checklist [8]
Joint inspection	CDSCO and State Licensing Authority officers	Site inspected against Schedule M, adapted to current WHO GMP guidelines [8]
Grant	State certifying authority	Unit WHO-GMP certificate and product COPPs issued [7]
Revalidation	Manufacturer, CDSCO and state	Renewal inspection before expiry [8] [7]

CDSCO publishes consolidated lists titled “WHO-GMP Certified Manufacturing Units for Certificate of Pharmaceutical Products (COPPs) in various states of India”; the most recent on its industry page is the list as of 31 December 2025, released on 17 June 2026 [9].

Revised Schedule M: India’s national GMP

Schedule M of the Drugs Rules, 1945 is India’s legally binding GMP. It was rewritten by G.S.R. 922(E), published on 28 December 2023 [10]. The revised schedule has 13 parts; Part I is titled “Good manufacturing practices for pharmaceutical products: main principles”, the same title as WHO’s TRS 986 Annex 2, and later parts cover sterile products (Part II), biological products (Part IV), investigational products (Part VII) and active pharmaceutical ingredients (Part XII) [10] [2].

Event	Date	Source
Revised Schedule M notified (G.S.R. 922(E))	28 December 2023	[10]
Compliance deadline, large manufacturers (turnover above ₹250 crore)	Six months from publication	[10]
Compliance deadline, small and medium manufacturers (turnover up to ₹250 crore)	Twelve months from publication	[10]
Corrigendum to G.S.R. 922(E) (G.S.R. 666(E))	25 October 2024	[11]
Draft extension notified (G.S.R. 10(E))	4 January 2025	[11]
Final extension (G.S.R. 127(E))	11 February 2025	[12]
Extended deadline for eligible MSMEs	31 December 2025	[12]

The extension was not automatic. Small and medium manufacturers had to apply to the Central Licence Approving Authority in Form A “within a period of three months from the date of publication of this notification, along with a plan of upgradation” [12].

Schedule M and WHO GMP are close but not identical. The sterile part of revised Schedule M, for example, keeps a classification table with 5.0 µm particle limits of 20 per m³ for Grade A, while WHO’s 2022 sterile text, like EU Annex 1, leaves Grade A 5 µm classification limits “not specified” [10] [3]. A WHO-GMP inspection in India is run against a Schedule M checklist adapted to WHO guidance [8], so buyers who need a specific standard should ask how the site meets that standard directly.

WHO-GMP vs WHO prequalification vs EU GMP

	WHO-GMP certificate (India)	WHO prequalification	EU GMP certificate
Who decides	State certifying authority after joint inspection with CDSCO [8] [7]	WHO [13]	EU inspectorates, with inspections coordinated by EMA [14]
What is assessed	Site GMP against Schedule M and WHO GMP; product COPPs [8]	Product dossiers or API master files, site inspections and QC testing [13]	Site compliance with EU GMP [14]
Output	Unit WHO-GMP certificate and COPPs [7]	Listing on WHO lists of prequalified APIs and finished products [13]	GMP certificate recorded in EudraGMDP [15]
Public record	CDSCO lists of WHO-GMP certified units [9]	WHO Public Inspection Reports (WHOPIRs) or Notices of Concern [16]	EudraGMDP public database [15]

WHO prequalification is WHO’s own programme. For medicines, it consists of “assessment of product dossiers (for FPPs) or master files (for APIs); inspection of manufacturing and clinical sites; and organization of quality control testing of products” [13]. APIs and finished products that pass are added to WHO’s lists of prequalified products [13]. Medicines prequalification covers HIV/AIDS, malaria, TB, reproductive health, hepatitis, diarrhoeal diseases and selected neglected tropical diseases, and has started covering selected biotherapeutics, including certain cancer treatments and human insulin [17]. Inspection outcomes are published as WHO Public Inspection Reports, or as Notices of Concern for non-compliance [16]. Most peptide APIs and research peptides fall outside these areas. The main peptide exception is semaglutide: WHO now invites semaglutide products for the management of diabetes to apply for prequalification [20]. A peptide supplier claiming “WHO approval” should therefore be asked for the WHO list entry or WHOPIR; without one, the claim almost always refers to a national WHO-GMP certificate.

For the EU, EMA states that “any manufacturer of medicines intended for the EU market must comply with EU good manufacturing practice (GMP) no matter where in the world they are located” [14]. The EudraGMDP database holds “manufacturing, import and wholesale-distribution authorisations as well as good manufacturing-practice (GMP) and good-distribution-practice (GDP) certificates”, with a public version available since 2011 [15].

Can suppliers use the WHO logo?

No. The use of the WHO emblem is governed by World Health Assembly resolution WHA1.133, which calls for measures to prevent use of the emblem, seal and name “without authorization by the Director-General, and in particular for commercial purposes by means of trade-marks or commercial labels” [18]. WHO states that its rules “do not allow the Organization’s name, emblem or logo to be used to promote specific companies, products or ideologies” [18]. A supplier that puts the WHO emblem next to “WHO-GMP” on its website or labels is implying an endorsement WHO does not give. Winhycare Pharma uses a plain text description and never the WHO emblem.

How to verify a WHO-GMP certificate

A certificate is evidence, not proof. Before relying on one:

Check	What to look for
Issuing authority	A national or state certifying authority, not “WHO”. In India, a state authority after joint inspection with CDSCO [8] [7]
Site and scope	Exact site address, dosage forms or sections covered, and the list of products with COPPs [7]
Dates	Date of grant and validity; Maharashtra certificates, for example, run for two years [7]
Public lists	Whether the unit appears in CDSCO’s latest list of WHO-GMP certified units [9]
Confirmation	Whether the issuing authority confirms the certificate; WHO’s guidelines provide for verification by the certifying authority [4]
Other claims	EU GMP claims checked in EudraGMDP [15]; WHO prequalification claims checked against WHO lists and WHOPIRs [13] [16]
Fit to your product	Whether the certified scope covers the operation you are buying, such as sterile filling or lyophilization, and the standard your market requires

Questions to ask a supplier that claims WHO-GMP

1. Which site holds the certificate? It should be the site that will make, fill or dry your product, not a group headquarters [19].
2. Which sections or dosage forms does it cover? Maharashtra’s procedure, for instance, is organised by section or dosage form, and a loan licensee can be certified only for dosage forms already granted to the owning manufacturer [7].
3. When was the last joint inspection, and when is revalidation due? COPPs are issued and revalidated after joint inspection [8].
4. Which products hold COPPs? The unit certificate lists them [7].
5. Is there any EU GMP certificate or WHO prequalification as well? Both can be checked in public databases [15] [13].
6. How does the site meet the standard your market applies? For sterile products bound for Europe, that is Annex 1, whose text WHO’s 2022 sterile guideline mirrors [3].

Where a supplier uses partner sites, the certificate belongs to the site that does the work. EU GMP’s chapter on outsourced activities puts the duty on the buyer: the contract giver “is responsible for assessing the legality, suitability and the competence of the Contract Acceptor”, and the contract acceptor “should not subcontract to a third party any of the work entrusted to him under the Contract without the Contract Giver’s prior evaluation and approval” [19]. The contract structure is covered in CDMO vs CMO vs CRDMO.

Where Winhycare Pharma fits

Winhycare Pharma offers lyophilisation and vial filling of peptides and biosimilars at WHO-GMP certified manufacturing partners in India, with projects managed from Hyderabad. Clients can bring their own peptide. Partner process details are shared per project, so buyers can check the certification and scope against the operation they are buying. See peptide lyophilisation services, biosimilar lyophilisation or send a lyophilisation enquiry. For peptide APIs, see peptide APIs.

Research peptides supplied by Winhycare Pharma are for laboratory research use only. Not for human or veterinary use.