GMP Certification in India
WHO-GMP · Schedule M · ISO 22716 (cosmetics) · Good Manufacturing Practice · typical timeline 8–16 weeks
GMP certification proves your pharma, nutraceutical, cosmetic or food unit manufactures under validated hygiene, documentation and quality controls. In India, revised Schedule M (2024) makes WHO-GMP-level compliance mandatory for all drug manufacturers. We deliver Schedule M / WHO-GMP readiness and third-party GMP certificates. Cost: ₹60,000–₹3,00,000; timeline 2–4 months.
Get a fixed-price quote in 24 hours
Tell us your industry, headcount and location. No retainer, no hidden certification-body fees.
Who needs GMP certification
- Pharma formulation and API units (Schedule M mandatory)
- Ayurvedic, nutraceutical and dietary supplement makers
- Cosmetics manufacturers (ISO 22716 / BIS)
- Food and packaging suppliers to pharma
GMP requirements in plain words
- Premises, HVAC, water system and zoning design
- Personnel hygiene, gowning and training
- Documentation: SOPs, BMR/BPR, specifications
- Validation: process, cleaning, equipment, computerised systems
- Quality control lab and stability programme
- Deviation, CAPA, change control, product recall, self-inspection
Certification process
- Step 1Gap assessmentWe audit your current processes against the standard and list exactly what is missing.
- Step 2DocumentationPolicies, procedures, records and formats written for your plant, not copied templates.
- Step 3Implementation & trainingYour team trained on the floor; internal audit and management review done with you.
- Step 4Certification auditStage 1 and Stage 2 audit by an IAF-accredited certification body of your choice.
- Step 5Certificate & surveillanceCertificate issued; we support annual surveillance audits for the full 3-year cycle.
GMP certification cost in India
Indicative 2026 all-inclusive prices — consulting, documentation, training and the certification-body audit fee. No separate charges. Full cost breakdown →
| Company size | All-inclusive price |
|---|---|
| Cosmetic / nutraceutical unit | ₹90,000–₹1,70,000 |
| Pharma formulation unit | ₹1,80,000–₹3,50,000 |
| API / sterile / multi-block | ₹3,50,000–₹7,50,000 |
Documents required
- Site master file and quality manual
- SOP set (100–250 SOPs for pharma)
- Batch manufacturing and packing records
- Validation master plan and reports
- QC specifications and stability data
- Deviation/CAPA/change control logs
Benefits
- Mandatory for Schedule M compliance and CDSCO licence renewal
- Required for export registrations (WHO-GMP, PIC/S markets)
- Fewer batch failures and regulatory observations
- Base for ISO 13485 and ISO 22716
Frequently asked questions
- Is GMP a certificate or a licence?
- WHO-GMP COPP is issued by the state drug controller; third-party GMP certificates come from certification bodies. We prepare you for both.
- What is revised Schedule M?
- The 2024 amendment to the Drugs Rules aligning Indian GMP with WHO standards, with phased deadlines for MSMEs.
- Does GMP cover cosmetics?
- Yes via ISO 22716 and BIS IS 24000 series.
GMP consultants by city
- Baddi
- Ludhiana
- Mohali
- Chandigarh
- Delhi
- Gurgaon
- Noida
- Ahmedabad
- Mumbai
- Pune
- Bangalore
- Chennai
- Hyderabad
- Kolkata
- Indore
Written by Sahil Dubey, CISA — lead consultant, PraxisQ Consulting LLP. Reviewed October 2026.
Get a fixed-price quote in 24 hours
Tell us your industry, headcount and location. No retainer, no hidden certification-body fees.