WHO GMP Certification: Good Manufacturing Practice to WHO Guidelines
Independent third-party audits and certificates against the World Health Organization good manufacturing practice guidelines, for manufacturers of finished pharmaceuticals, active ingredients, herbal medicines, nutraceuticals and contract manufacturers preparing for buyers, tenders and regulatory inspections.
- Audit against the WHO GMP main principles and the WHO annexes for your products
- On-site audit of premises, utilities, production, quality control and batch records
- Company certificate your buyers and distributors can verify online
From $1,500Certified by EUROTECH
Or call +1 307 205 1833, Monday to Friday, 09:00 to 18:00 (US Mountain Time)
- Issuing certificates since 2004
- 500+ certificates issued
- On-site audits in the USA, Europe, Asia, Africa
- Verify any EUROTECH certificate
What is WHO GMP certification?
WHO GMP means good manufacturing practice as described by the World Health Organization. WHO publishes GMP guidelines through its Expert Committee on Specifications for Pharmaceutical Preparations, in the annexes of the WHO Technical Report Series (TRS). The main principles for pharmaceutical products are complemented by annexes for active pharmaceutical ingredients, sterile products, herbal medicines, water for pharmaceutical use, validation and other topics. Many countries base their national GMP rules on these guidelines, and India's revised Schedule M is closely aligned with them.
WHO GMP certification by EUROTECH is an independent audit of your plant against those guidelines. A EUROTECH auditor reviews your quality system documents, visits your site, follows a batch from raw material receipt to release and checks that premises, utilities, equipment, people and records meet the WHO requirements for your products. After an independent review, we issue a certificate naming the site, the dosage forms or products covered and the WHO guidelines audited.
There are two kinds of WHO GMP certificate, and it helps to know which one you need. A regulatory WHO-GMP certificate and the Certificate of Pharmaceutical Product (CoPP) are issued by your national medicines regulator under the WHO Certification Scheme, mainly for exporting medicines. A third-party WHO GMP certificate, like ours, is voluntary evidence for buyers, distributors, private label clients and tenders, and a practical way to find and close gaps before a regulatory inspection.
WHO GMP, cGMP, EU GMP and PIC/S: how they compare
GMP rules for medicines share the same goals but differ in who writes them, who enforces them and which markets accept them. The right reference depends on where your products are sold and what your customers ask for.
Many manufacturers in India, Africa, Asia and the Middle East start with WHO GMP because it is the reference their national rules and export markets use. Plants that later target the USA or Europe build on the same quality system and add the specific requirements of US cGMP or EU GMP.
| Aspect | WHO GMP | US cGMP | EU GMP and PIC/S |
|---|---|---|---|
| Written by | World Health Organization expert committee | US federal regulations (21 CFR) | European Commission; PIC/S guide for member authorities |
| Legal status | Guidelines, adopted into national law by many countries | Binding law for products sold in the USA | Binding in the EU; adopted by PIC/S member authorities |
| Typical markets | India, Africa, Asia, Middle East, Latin America, UN procurement | USA | EU, UK and PIC/S member countries |
| Our service | WHO GMP certification (this page) | cGMP certification | Gap audits against EU GMP or PIC/S on request |
For food and dietary supplement GMP see our GMP certification page, and for cosmetics see ISO 22716.
What the WHO GMP audit covers
The WHO main principles of GMP for pharmaceutical products describe the elements of a pharmaceutical quality system. The audit checks each element against what actually happens in your plant, not only against your procedures.
- Pharmaceutical quality system: quality risk management, management review and product quality reviews
- Personnel and training: key personnel, responsibilities, hygiene and documented training
- Premises and equipment: layout, cleanroom grades where needed, maintenance, calibration and cleaning
- Utilities: water for pharmaceutical use and heating, ventilation and air conditioning (HVAC)
- Qualification and validation: equipment qualification, process, cleaning and analytical method validation
- Materials and production: supplier approval, sampling, dispensing, in-process controls and line clearance
- Quality control: specifications, testing, stability, reference standards and out-of-specification investigations
- Documentation: batch manufacturing and packaging records, data integrity, change control, deviations, CAPA, complaints and recalls
Products with special risks are audited against the matching WHO annex as well, for example sterile products, active pharmaceutical ingredients or herbal medicines. We agree the annexes in scope with you before the audit.
Benefits of WHO GMP certification
What an independent WHO GMP audit and certificate give your manufacturing business.
Inspection readiness
An outside auditor tests your plant against the WHO guidelines before a regulator, a buyer or a tender committee does, so gaps are closed on your timeline.
Buyer and partner confidence
Distributors, marketing companies and brand owners often ask contract manufacturers for WHO GMP evidence before signing supply or loan licence agreements.
Export market support
Many export markets in Africa, Asia, the Middle East and Latin America expect WHO GMP. A certificate with a clear scope supports your dossiers and buyer approvals.
Alignment with national GMP rules
National GMP rules such as India's revised Schedule M are based on WHO GMP. The audit shows where your plant stands against them.
Fewer deviations and rejected batches
Strong validation, in-process controls and data integrity reduce batch failures, recalls and investigation time.
Continuous improvement
Yearly surveillance audits keep your quality system current when products, equipment, suppliers or the WHO guidelines change.
Has a buyer or tender asked for WHO GMP?
Tell us your products, dosage forms, sites and the markets you supply. We confirm the scope and send a written quote with audit days and every fee.
Industries we serve
Risks and WHO requirements differ by product. We scope each WHO GMP audit to your dosage forms, processes and the WHO annexes that apply to them.
Finished pharmaceutical products
WHO GMP main principles
Tablets, capsules, oral liquids, ointments and other non-sterile dosage forms. The audit focuses on dispensing, mixing, granulation, compression, filling, packaging, in-process controls and cross-contamination.
Sterile products and injectables
WHO GMP for sterile pharmaceutical products
Injections, eye drops and other sterile products. Beyond the main principles, the audit covers cleanroom classification, environmental monitoring, aseptic process simulation, sterilisation and the contamination control strategy.
Active pharmaceutical ingredients
WHO GMP for active pharmaceutical ingredients
API and intermediate manufacturers. The audit covers starting materials, process controls, impurities, cleaning, change control and the quality unit's release of each batch.
Herbal and Ayurvedic medicines
WHO GMP for herbal medicines
Herbal, Ayurvedic and traditional medicine manufacturers. The audit checks identification and testing of herbal materials, contamination control, processing and the quality documents specific to herbal products.
Nutraceuticals and food supplements
WHO GMP principles, scoped to your products
Nutraceutical and supplement makers who supply pharmaceutical-style buyers. Supplement makers selling into the USA should also see cGMP certification.
Contract and third-party manufacturers
WHO GMP and your clients' quality agreements
Contract manufacturers, loan licence and third-party manufacturing units that produce for several marketing companies. The audit checks quality agreements, technology transfer, batch release responsibilities and segregation between clients.
Packaging, testing and storage
WHO guidelines for the activity in scope
Contract packers, testing laboratories and warehouses serving pharmaceutical companies. The audit covers the WHO requirements for that activity, such as good storage and distribution practice or good practices for quality control laboratories.
Applicable WHO GMP requirements
WHO GMP is a family of guidelines published in the WHO Technical Report Series. We agree the guidelines in scope with you at the start, and the certificate names them.
WHO GMP main principles
Pharmaceutical products
WHO good manufacturing practices for pharmaceutical products: main principles. This is the core reference for every WHO GMP audit.
- Pharmaceutical quality system and risk management
- Personnel, premises and equipment
- Qualification, validation and production
- Quality control, documentation, complaints and recalls
WHO product annexes
Sterile, API and herbal products
Specific WHO GMP guidelines add requirements for sterile pharmaceutical products, active pharmaceutical ingredients and herbal medicines.
- Cleanrooms and aseptic processing
- API process controls and impurities
- Herbal material identification and testing
- Contamination control
WHO supporting guidelines
Utilities, validation and data
Supporting WHO guidelines cover the systems every plant relies on. We apply those relevant to your operation.
- Water for pharmaceutical use
- HVAC systems
- Validation
- Data integrity
National GMP rules
Rules based on WHO GMP
Where your national GMP rules are based on WHO GMP, such as Schedule M in India, we can include them in the audit scope so the report shows where you stand against both.
- Revised Schedule M (India)
- Other national GMP rules on request
- Licence conditions noted, not assessed
- Gap list against both references
We audit against the current published WHO guidelines. If WHO revises a guideline during your certification cycle, we tell you what changes and give you time to adapt before the next surveillance audit.
Our WHO GMP certification process
Eight clear stages from application to certificate. You know what happens next, who decides and what it costs before you commit.
- 1
Application and initial assessment
You send your products, dosage forms, sites and employee numbers. We confirm we can audit your scope and send a written quote.
- 2
Scope and requirements review
We agree the products, processes and sites in scope, the WHO guidelines and annexes, and the audit plan and dates.
- 3
Documentation review
The auditor reviews your site master file, quality manual, key procedures, validation master plan and recent product quality reviews.
- 4
WHO GMP audit
On site, the auditor inspects production, utilities, warehouses and the QC laboratory, follows batch records and interviews staff.
- 5
Corrective actions, if required
Findings are explained in a written report. You send root cause, corrections and evidence within the agreed time, and we verify them.
- 6
Independent certification decision
A qualified reviewer who did not take part in the audit checks the audit file and makes the certification decision.
- 7
Certificate issuance
You receive a WHO GMP certificate naming the site, dosage forms and WHO guidelines audited, listed on our online verification portal.
- 8
Ongoing compliance and surveillance, where applicable
Yearly surveillance audits confirm that your quality system stays effective as products, equipment and suppliers change.
Documentation requirements
A WHO GMP audit is judged on documents and records. These are the items we typically sample; the depth expected depends on your products and risk.
Site master file
Description of the site, activities, products, premises, utilities, equipment, organisation and quality system.
Quality manual and procedures
Standard operating procedures for production, quality control, cleaning, maintenance, warehousing and quality assurance.
Batch manufacturing and packaging records
Complete, signed records for recent batches, from dispensing to packaging, with in-process checks and release decisions.
Qualification and validation
Validation master plan, equipment qualification, process, cleaning and analytical method validation reports.
Utilities records
Water system qualification and monitoring, HVAC qualification, pressure differentials and environmental monitoring.
Quality control records
Specifications, test methods, raw data, stability studies, out-of-specification investigations and reference standards.
Deviations, CAPA and change control
Deviation reports, root cause investigations, corrective and preventive actions and approved changes.
Training, complaints and recalls
Training records and competence, complaint handling, recall procedure and a recent mock recall, plus self-inspection reports.
Data integrity matters as much as the data. Records should be attributable, legible, contemporaneous, original and accurate, whether on paper or in electronic systems.
Why choose EUROTECH for WHO GMP certification?
Professional certification services
EUROTECH has issued certificates since 2004, with more than 500 certificates issued to companies across several continents.
Experienced technical auditors
We assign auditors with pharmaceutical manufacturing and quality control backgrounds that match your dosage forms, and confirm the audit team before the visit.
International client support
On-site audits in India, Asia, the Middle East, Africa, Europe and the Americas, with our office in Sheridan, Wyoming and an agency office in Istanbul.
Transparent certification process
Audit days, travel and every fee are in a written quote before you commit. Findings and decisions come in writing.
Efficient application management
Combined audits with ISO 9001, ISO 13485 or cGMP avoid checking the same records twice, and certificates can be checked online.
Industry-specific technical expertise
Our manufacturing practice services cover WHO GMP, cGMP, GMP, ISO 22716 and ISO 13485, so we can plan your next market with you.
Please note: the World Health Organization does not certify companies. A EUROTECH WHO GMP certificate is a voluntary third-party certificate of conformity with the WHO GMP guidelines. It does not replace the WHO-GMP certificate or Certificate of Pharmaceutical Product (CoPP) that a national regulatory authority issues under the WHO Certification Scheme, such as CDSCO and the State Licensing Authority in India, and it does not replace manufacturing licences, regulatory inspections or WHO prequalification.
Ready to start your WHO GMP certification?
Apply now or ask our certification team a question. We reply with the scope, the audit plan and a written quote.
WHO GMP certification: frequently asked questions
What is WHO GMP certification?
It is an audit of a manufacturing site against the World Health Organization good manufacturing practice guidelines, followed by a certificate that states the site, products and guidelines audited. Our certificate is a voluntary third-party certificate; regulatory WHO-GMP certificates are issued by national medicines regulators.
What does WHO GMP certified mean?
It means a manufacturing site was found to meet the WHO GMP guidelines for the products named on the certificate. Always check who issued the certificate, the site address, the scope and the expiry date.
Who issues WHO GMP certificates?
WHO itself does not certify companies. Under the WHO Certification Scheme, national regulatory authorities issue WHO-GMP certificates and Certificates of Pharmaceutical Product, for example CDSCO with the State Licensing Authority in India. Independent certification bodies such as EUROTECH issue voluntary third-party certificates of conformity with the WHO GMP guidelines.
Does a EUROTECH certificate replace the regulatory WHO-GMP certificate or CoPP?
No. If an importing country requires a CoPP or a regulator-issued WHO-GMP certificate, you must apply to your national regulatory authority. Our certificate serves buyers, partners and tenders, and our audit helps you prepare for the regulatory inspection.
How much does WHO GMP certification cost?
With EUROTECH it starts at $1,500. The final price depends on the dosage forms and processes, sterile or non-sterile production, employees, sites, the WHO annexes in scope and travel, and is confirmed in a written quote.
How do I get WHO GMP certification?
Implement a quality system that meets the WHO GMP guidelines, run it with records for a few months, then apply. We agree the scope, review your documents, audit your site, verify any corrective actions and, after an independent decision, issue the certificate.
How long does WHO GMP certification take?
It depends on how ready your plant is and how many findings need correcting. The on-site audit usually takes two to several days depending on size and dosage forms. We set out the timeline in your written quote.
What is the difference between WHO GMP and cGMP?
WHO GMP refers to the World Health Organization guidelines used by many countries. cGMP usually refers to the current good manufacturing practice regulations in the USA under 21 CFR. They share the same principles, but US cGMP is binding law for products sold in the USA and has its own specific requirements.
Is WHO GMP mandatory in India?
Indian manufacturers must comply with Schedule M of the Drugs Rules, which was revised to align closely with WHO GMP. A regulator-issued WHO-GMP certificate is generally needed for exports that require a CoPP. A third-party certificate is voluntary.
Can herbal and Ayurvedic manufacturers get WHO GMP certification?
Yes. Herbal and traditional medicine manufacturers are audited against the WHO main principles together with the WHO GMP guidelines for herbal medicines.
Can nutraceutical manufacturers get WHO GMP certification?
Yes, we can audit nutraceutical plants against the WHO GMP principles where buyers ask for it. If you sell supplements into the USA, cGMP certification to 21 CFR Part 111 is usually the more relevant reference.
Is WHO GMP the same as WHO prequalification?
No. WHO prequalification is a WHO assessment of specific medicines, vaccines and manufacturing sites for UN procurement. It is a separate WHO programme and is not provided by certification bodies.
How long is a WHO GMP certificate valid?
Our WHO GMP certificates are valid for three years, with yearly surveillance audits. Validity of regulator-issued certificates is set by the issuing authority.
Can WHO GMP be combined with other certifications?
Yes. WHO GMP combines well with ISO 9001, and medical device makers can combine it with ISO 13485. A combined audit avoids reviewing document control, CAPA and training twice.
Related services
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- cGMP certification
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- ISO 13485 certification
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- ISO 22716 cosmetics GMP
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- ISO 9001 certification
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- HACCP certification
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Request a quote for WHO GMP certification
Tell us your company, sites and the standard you need. We reply with a written quote and the audit plan.
Prefer to talk? Call +1 307 205 1833
Monday to Friday, 09:00 to 18:00 (US Mountain Time)