GMP Certification

Overview

Good Manufacturing Practices (GMP) certification confirms that products are consistently produced and controlled according to defined quality standards. In India it is most commonly associated with pharmaceuticals under the Drugs and Cosmetics Act, 1940 and its Rules, where Schedule M sets out manufacturing requirements. WHO-GMP certification for exports is granted through the State Drugs Control administration and the Central Drugs Standard Control Organisation. GMP principles also apply to food, cosmetics, and related sectors under their respective rules.

Objective

To certify that a manufacturing unit follows recognised good manufacturing practices for quality and safety.

Characteristics

• Confirms consistent quality control in manufacturing
• Linked to Schedule M requirements for pharmaceuticals in India
• WHO-GMP certification supports export of pharmaceutical products
• Covers premises, processes, documentation, and quality systems
• Requires ongoing compliance and periodic inspection

Eligibility

• Manufacturing units holding the relevant product licence
• Pharmaceutical manufacturers seeking WHO-GMP for exports
• Food and cosmetic manufacturers following applicable GMP norms
• Units able to meet premises, equipment, and documentation standards

Governing law

• Drugs and Cosmetics Act, 1940 and Rules, 1945 (Schedule M)
• Central Drugs Standard Control Organisation (CDSCO)
• State Drugs Control Administration
• World Health Organization GMP guidelines (for WHO-GMP)

The process

1. 1
   Assess readiness

   Review the facility against the applicable GMP requirements and address gaps in premises and processes.

2. 2
   Prepare documentation

   Compile quality manuals, standard operating procedures, and batch records.

3. 3
   Apply to the authority

   Submit the application to the relevant drug control authority for the applicable certificate.

4. 4
   Inspection

   The authority inspects the unit to verify compliance with the standards.

5. 5
   Certificate issued

   On satisfactory inspection, the GMP or WHO-GMP certificate is granted.

Documents required

• Manufacturing licence for the product
• Site master file and facility layout
• Standard operating procedures and quality manual
• Product and batch manufacturing records
• Details of equipment and testing facilities
• List of technical and qualified staff

Benefits

• Recognition of consistent manufacturing quality
• Support for export of pharmaceutical products through WHO-GMP
• Greater buyer and regulator confidence
• A structured quality system across the facility
• Easier access to markets that require GMP compliance

Frequently asked questions