GMP Certification

Good Manufacturing Practices certification for pharmaceutical, food, and cosmetic manufacturers

Validity: 1–3 years (varies by certifying body)

What is GMP Certification?

GMP certification demonstrates that your manufacturing facility meets the hygiene, process control, and quality standards required by regulators and export buyers. We assess your facility, prepare the documentation package, and obtain the relevant GMP certificate.

GMP (Good Manufacturing Practices) certification confirms that a manufacturing facility meets the hygiene, process control, and quality standards required for pharmaceutical, food, or cosmetic manufacturing. In the pharmaceutical sector, Schedule M of the Drugs Rules, 1945, sets mandatory GMP requirements for drug manufacturing licences in India; WHO-GMP or EU-GMP certification is required for export to regulated markets. In the food sector, GMP is a component of FSSAI's FSMS requirements and HACCP. In cosmetics, GMP for cosmetics is referenced in FSSAI and BIS standards. Many international buyers, particularly for export, require WHO-GMP, IS 15490 (Indian GMP Standard for Pharma), or ISO 22716 (GMP for Cosmetics) certificates from their Indian suppliers. GMP certification is also a pre-condition for FSSAI Central Licence and for DSIR recognition.

Who Needs GMP Certification?

Pharmaceutical manufacturers seeking export markets or drug licence renewal, food manufacturers seeking FSSAI Central Licence or export authorisation, cosmetic manufacturers supplying to regulated markets or large retailers, and Ayurvedic and nutraceutical manufacturers.

What's Included

GMP certificate issued by the relevant body (WHO-GMP, ISO 22716, or IS 15490)
Gap analysis against the applicable GMP standard completed
SOPs, master batch records, and required documentation updated
Facility inspection by certifying body supported
Export market access or drug licence renewal documentation supported

⚠️ Penalty for Non-Compliance

Non-compliance with Schedule M (pharmaceutical GMP) can lead to suspension or cancellation of the drug manufacturing licence. Exporting pharmaceutical or food products without the required GMP certificate is a ground for rejection at the port of the importing country.

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How It Works

1
Gap analysis
We audit your facility against the applicable GMP standard and provide a gap report.
2
Documentation preparation
SOPs, master batch records, quality control procedures, and validation documents are prepared or updated.
3
Facility compliance
Identified gaps in facility, equipment, and processes are addressed.
4
Pre-audit internal inspection
An internal audit against the GMP standard is conducted.
5
Certification audit
The certifying body (WHO, accredited CB, CDSCO state authority) conducts the facility inspection and audit.
6
Certificate issued
The GMP certificate is issued on successful audit.

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Documents Required

Items marked Required are mandatory; others are situational.

Facility

Current factory layout planRequired
Equipment list and calibration recordsRequired
Existing SOPs

Regulatory

Drug Manufacturing Licence or FSSAI LicenceRequired
List of products in scopeRequired

Fees & Pricing

Fees

Government fee (CDSCO WHO-GMP)

As per CDSCO fee schedule

Varies

Accredited CB fee

As per the CB's fee schedule for the specific GMP standard and facility size

Varies

Professional fee

Quoted after reviewing the facility and the target GMP standard

Varies

* Government fees may vary. GST applicable on professional fees. Final pricing confirmed after review.

Frequently Asked Questions

Is WHO-GMP mandatory for pharmaceutical export?

Yes. Most regulated markets (EU, US, and many developing countries) require WHO-GMP or a bilateral equivalent as a condition for pharmaceutical import. Indian exporters must obtain WHO-GMP certification from the Central Drugs Standard Control Organisation (CDSCO) or an accredited certifying body.

Is GMP certification the same as Schedule M compliance?

Schedule M sets the mandatory GMP requirements for drug manufacturing in India under the Drugs Rules, 1945. WHO-GMP certification is an additional external audit confirming that the facility meets the WHO's GMP standard, which is higher in some areas than Schedule M.

What is ISO 22716?

ISO 22716 is the international GMP standard for cosmetics. It is not mandatory in India but is required by many retailers and export buyers. It is enforced in the EU under the EU Cosmetics Regulation.

Does GMP certification cover all products made at a facility?

The GMP certificate covers a defined scope — typically the product categories manufactured at the audited facility. Adding new product categories may require a scope extension audit.

How long does the GMP certificate last?

This varies by type. WHO-GMP certificates issued by CDSCO are typically valid for 3 years. ISO-based GMP certificates are valid for 3 years with annual surveillance.

What is the difference between CDSCO issuing WHO-GMP and an accredited CB?

CDSCO issues the government WHO-GMP certificate that is legally recognised under WHO's PICS framework. Accredited certification bodies issue certificates under ISO 22716, IS 15490, or their own GMP scheme — these are accepted by buyers but not always by all regulatory authorities.