Certification
WHO-GMP Certification Consulting
WHO-GMP certification is a voluntary certification usually required for export markets, separate from statutory Schedule M compliance. Pharmateq prepares the facility, the documentation and the Site Master File, and attends the inspection with you.
Last updated: 14 August 2026
What is involved
- Gap assessment against WHO TRS requirements
- Site Master File preparation
- Documentation and validation package completion
- Application filing with the state FDCA
- Pre-inspection readiness review and mock audit
- Attendance at the inspection and response to observations
- COPP and market authorisation support where required
Questions
The five we are asked most
How long does Revised Schedule M compliance take?
A gap assessment takes 2-4 weeks. Full remediation typically runs 6 to 18 months, depending on how much civil, HVAC and utility work your facility needs. Documentation-only gaps can be closed in 3-4 months.
What does a Schedule M upgrade cost?
Industry estimates for a full MSME facility upgrade commonly fall between Rs 10 and Rs 15 crore, but that figure assumes a complete rebuild. Most plants we assess need considerably less once mandatory items are separated from optional ones. We give you a costed breakdown before you commit to anything.
Do you work outside Gujarat?
Yes. We are based in Ahmedabad and work across India, including Baddi, Indore-Pithampur, Hyderabad and Mumbai. For clients outside Gujarat we typically combine monthly on-site visits with continuous remote documentation support.
Will you be present during the actual inspection?
Yes. Presence and support during customer and regulatory audits is part of our standard engagement.
What is the difference between Schedule M and WHO-GMP?
Revised Schedule M is India statutory GMP requirement under the Drugs and Cosmetics Rules, and mandatory for every licensed manufacturer. WHO-GMP certification is a separate, voluntary certification usually required for export markets. The revised Schedule M was aligned with WHO standards, so a compliant plant is well positioned for WHO-GMP, but they are not the same thing and require separate documentation.
Start here
Find out what your plant actually needs.
A 30-minute call, no charge, no obligation. Tell us your dosage form, your licence status and your deadline. We will tell you honestly whether you have a documentation problem, an engineering problem, or both.
- A senior consultant on the call, not a salesperson
- A written summary of what we discussed within 48 hours
- No proposal until you have seen a gap report
Request a free gap assessment
We reply within one working day.