WHO-GMP Certification
Good manufacturing practice certification for pharmaceutical units supplying regulated markets.
WHO-GMP certification confirms that a pharmaceutical manufacturing unit operates to good manufacturing practice as set out in the World Health Organization guidelines. In India it is issued by the state licensing authority following a joint inspection.
For a domestic manufacturer it is largely an export document. Regulatory authorities in many importing countries require it, and it is typically accompanied by a Certificate of Pharmaceutical Product for the specific products being exported.
What this costs
Compliance Certificate Renewal
₹9,404 plus GST
- WHO - GMP Compliance Certificate
What it is and is not
WHO-GMP certification attests to the manufacturing standard of the facility. It is not a product approval and it does not authorise sale anywhere — the importing country’s own registration process does that.
It is also distinct from the Schedule M compliance every Indian manufacturer must meet under the Drugs and Cosmetics Rules. Schedule M is the domestic baseline; WHO-GMP is the higher standard that export markets look for.
What the inspection examines
- Premises and layout, including segregation and unidirectional material flow
- Air handling, with classified areas and differential pressures
- Water system, including generation, storage and distribution of purified water
- Equipment qualification and calibration records
- Process validation for each product
- Quality control laboratory, its instruments and analytical method validation
- Documentation — batch records, standard operating procedures and change control
- Personnel qualification, training records and hygiene practices
- Stability studies and the retention sample programme
Documentation is what usually fails
Facilities are rarely rejected because the plant is inadequate. They are rejected because the documentation does not demonstrate that the plant was operated as described — gaps in batch records, uncontrolled changes, calibration overdue, deviations not investigated.
The governing principle in a good manufacturing practice audit is that what is not documented did not happen. Preparation therefore concentrates on records rather than on the building.
The Certificate of Pharmaceutical Product
Importing regulators typically ask for both the WHO-GMP certificate for the facility and a Certificate of Pharmaceutical Product for each product, issued in the WHO format.
The product certificate confirms the product is licensed in India and states whether it is marketed domestically. Some countries will not register a product that is not sold in its country of origin, which is worth establishing before planning an export-only product.
How we handle it
- 1 Gap assessment The facility and its documentation are assessed against WHO guidelines before any application, since it is the records that usually fail.
- 2 Remediation Gaps in validation, calibration, documentation and training are closed and evidenced.
- 3 Site master file The site master file is prepared or updated to reflect the facility as it actually operates.
- 4 Application The application is filed with the state licensing authority with the technical annexures.
- 5 Joint inspection The joint inspection is conducted, and we prepare the team for how the audit will proceed.
- 6 Certificate and product certificates The certificate is issued, and Certificates of Pharmaceutical Product obtained for the products being exported.
Frequently asked questions
Is WHO-GMP mandatory?
Not for domestic sale, where Schedule M compliance under the Drugs and Cosmetics Rules applies. It becomes necessary for export to markets whose regulators require it.
Does it let us sell in the importing country?
No. It attests to the manufacturing standard of the facility. Marketing authorisation comes from the importing country’s own product registration process.
How long is it valid?
It is issued for a fixed term, commonly three years, with re-inspection required for renewal. Significant changes to the facility can require reassessment sooner.
Why do facilities fail inspection?
Almost always on documentation rather than on the plant — incomplete batch records, uncontrolled changes, overdue calibration, deviations not investigated. What is not documented is treated as not having happened.
What is a CoPP?
A Certificate of Pharmaceutical Product, issued per product in the WHO format, confirming it is licensed in India. Importing regulators generally require it alongside the facility certificate.
What is not included. Government fees, statutory charges, stamp duty, court and registry fees, digital signature costs and any third-party professional charges are separate and payable at actuals. GST applies on professional fees where indicated. Prices shown are indicative and may change without notice; we confirm the total in writing before any work begins — see our terms on pricing.
Talk to us about WHO-GMP Certification
Share your requirement and our team will confirm the documents needed, the exact charges and a realistic timeline — usually the same working day.
- Expert document checking before submission
- Regular status updates on WhatsApp
- Transparent professional charges
- Assistance in Marathi & English
Request This Service
More in Licences & Registrations
Have a Legal or Documentation Need?
Talk to our experts today. Transparent pricing, fast processing and dedicated support.