GMP Certification for Pharma, Food, Cosmetics and AYUSH
Understand which GMP requirement or certificate applies to your sector and prepare your plant for inspection and audit.
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Good Manufacturing Practices (GMP) are quality and hygiene requirements that a manufacturing facility must follow so that products are made consistently and safely. In India the applicable rules depend on the sector: drugs follow Schedule M of the Drugs and Cosmetics Rules, with a revised version now notified, while food, cosmetics and AYUSH products have their own requirements. Some certificates, such as the WHO-GMP certificate used for exports, are issued by the drug regulator, while others are voluntary certificates from private bodies. Our team helps you work out which one applies, close the gaps in premises, documentation and quality systems, and prepare for inspection.
Who provides this service: our team of Company Secretaries and compliance specialists.
Who Needs GMP Certification?
- Pharmaceutical manufacturers and loan licensees preparing for inspection
- Food processors needing to meet hygiene and manufacturing conditions
- Cosmetic manufacturers setting up or upgrading a production facility
- AYUSH medicine makers following the requirements of their sector
- Exporters whose overseas buyers or regulators ask for a GMP certificate
Key Benefits
- Clear explanation of which GMP requirement or certificate applies to your sector and purpose
- Gap assessment of premises, equipment, personnel and documentation against the relevant requirements
- Preparation of quality manual, standard operating procedures and batch records
- Mock inspection that mirrors what a regulator or auditor is likely to examine
- Support in responding to inspection observations and closing corrective actions
- Guidance for exporters on certificates that overseas buyers or regulators may ask for
How It Works
Identify the applicable requirement
We establish whether you make drugs, food, cosmetics or AYUSH products, and whether you need to meet a statutory rule, a regulator-issued certificate or a voluntary private certification.
Facility and system gap assessment
Our team reviews layout, utilities, equipment, hygiene, personnel practices, documentation and quality control, and lists the changes needed against the relevant requirements.
Documentation build
Standard operating procedures, master formulae, batch manufacturing records, cleaning and calibration formats and a quality manual are prepared to suit your actual operations.
Training and implementation
Production, quality and warehouse staff are trained on hygiene, record keeping and deviation handling, and the system runs long enough to generate genuine records for inspectors.
Mock inspection
A mock audit checks the facility as an inspector would. Findings are documented, corrective and preventive actions are closed and the team is briefed on how to handle the inspection.
Application and inspection support
We assist with the application to the competent authority or certification body, support you during inspection and help draft compliance reports for any observations.
Documents Required
- Registration or incorporation proof of the manufacturing entity
- Site plan and layout of the manufacturing premises
- Existing manufacturing licence, FSSAI licence or relevant sector licence
- List of products, formulations or food categories manufactured
- Equipment list with qualification and calibration records
- Qualification details of technical staff and quality personnel
- Standard operating procedures and batch manufacturing records
- Water, environmental and raw material test reports where applicable
Timeline and Fees
Indicative timeline: Readiness work generally takes a few months; inspection and certificate issue depend on the regulator or certification body involved.
Professional fee: Our fee depends on the sector, the size and condition of the facility, the number of products and the extent of documentation and training needed. Regulator fees and certification body audit charges are separate and differ by authority.
What Can Go Wrong if This Is Missed or Done Incorrectly
- Manufacturing without meeting the applicable GMP requirements can lead to suspension or cancellation of the sector licence
- Inspection observations that are not closed on time can delay certificates needed for export
- Describing a private certificate as a government approval can mislead customers and attract regulatory action
- Weak batch records and deviation handling are common reasons for adverse inspection findings
Frequently Asked Questions
What is GMP certification and who needs it?
GMP refers to practices that ensure products are produced and controlled to quality standards. Manufacturers of drugs, food, cosmetics and AYUSH products need to follow the requirements applicable to their sector. Whether you need a certificate or just compliance depends on the regulator, your products and whether you export.
What is the difference between Schedule M and WHO-GMP?
Schedule M sets the statutory GMP requirements for drug manufacturers under the Drugs and Cosmetics Rules. WHO-GMP refers to the certification scheme followed for export, where the drug regulator can issue a certificate after inspection. A unit usually has to meet the Indian requirements before it is considered for a WHO-GMP certificate.
Has Schedule M been revised?
Yes, a revised Schedule M has been notified with updated expectations on quality systems, and compliance timelines were phased depending on the size of the manufacturer. Because dates and categories have been revisited, always confirm the current applicability on the official regulator notifications. Our team helps map it to your unit.
Is GMP required for food and cosmetics too?
Food businesses must follow the good manufacturing and hygiene requirements prescribed under the food safety regulations as a condition of their licence. Cosmetics and AYUSH products have their own manufacturing requirements under the drugs and cosmetics framework. The specific rules differ, so the sector comes first.
Can a voluntary GMP certificate replace a licence?
No. A certificate from a private body is voluntary and does not replace the manufacturing licence, FSSAI licence or other permission your sector requires. It can support buyer confidence, but it should be described accurately and never presented as a government approval.
Official Sources
Rules, forms and fees change. Check the current position on the official portal:
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Last reviewed: . Laws, fees and procedures change; check the official portal before you act.
Disclaimer: The information on this page is for general informational purposes only and does not constitute professional legal, tax or compliance advice. Requirements vary by situation. Please consult a qualified CA or CS for advice specific to your needs. Government fees and timelines are subject to change; verify with the relevant authority before proceeding.