Good Manufacturing Practice (GMP) is a system ensuring products are consistently produced and controlled to quality standards. For drug manufacturers in India, compliance with revised Schedule M of the Drugs Rules is mandatory, and WHO-GMP certification from regulators supports exports. Food, cosmetic and supplement makers often obtain GMP certification from accredited bodies.
Core GMP requirements
- Suitable premises and equipment
- Validated processes and cleaning
- Trained personnel and hygiene
- Quality control testing
- Documentation and batch records
- Complaint handling and recalls
Who needs GMP
- Drug manufacturers (mandatory)
- Cosmetic and nutraceutical makers (strongly expected)
- Food processors supplying demanding buyers
Certification process
- Gap assessment.
- Upgrade facilities and documentation.
- Internal audits.
- Inspection by regulator or certification body.
- Certificate and periodic re-inspections.
Short on time? Leegal can handle GMP Certification for you, end to end.
Get expert help →Benefits
Regulatory compliance, export eligibility, fewer recalls and stronger buyer confidence.
Frequently asked questions
Is GMP mandatory for all pharma units?
Yes. Drug manufacturing licences require compliance with Schedule M, with revised requirements phased in for smaller units.
What is WHO-GMP?
A certification based on WHO guidelines, issued by drug regulators after inspection, often required for exports.
How long is GMP certification valid?
Validity depends on the issuing authority or body, commonly a few years with surveillance.
Does GMP apply to contract manufacturers?
Yes. Contract manufacturers must meet GMP, and brand owners should audit them.
Let Leegal handle your GMP Certification
Documentation, filing and follow-up by a dedicated expert, so you can focus on running your business.
- Dedicated point of contact
- Transparent pricing
- Pan-India service