Make your plant inspection‑proof.
SSATAX gets your WHO GMP (Good Manufacturing Practices) certification online built for India's revised Schedule M norms, now strictly enforced by the CDSCO from 2026.
Service Fee + Govt / audit fees only
The Standard, Explained
What is WHO GMP Certification?
WHO GMP (Good Manufacturing Practices) is the World Health Organization's global benchmark for pharmaceutical manufacturing quality. It ensures products are consistently produced and controlled to the same quality standard, batch after batch not just tested at the end of the line.
India's own Schedule M (under the Drugs & Cosmetics Rules) is modelled on WHO GMP. The revised Schedule M, enforced from 2026, pushes India's domestic legal minimum even closer to true WHO GMP and PIC/S benchmarks which is exactly why this certification matters more now than ever.
PILLAR 01
Quality Assurance
A documented Pharmaceutical Quality System (PQS) end-to-end.
PILLAR 02
Personnel & Training
Qualified staff, defined roles, ongoing GMP training.
PILLAR 03
Premises & Equipment
Validated facilities, utilities & manufacturing equipment.
PILLAR 04
Documentation
Batch records, SOPs & traceability from raw material to patient.
Why This Matters Now
New rules making WHO GMP essential in 2026
India's pharma manufacturing landscape has fundamentally changed. Here's what's now in force and how WHO GMP lines up with it.
Revised Schedule M now binding
From 1 January 2026, the DCGI mandates strict compliance with the revised Schedule M norms for all drug manufacturers, replacing the outdated 2001 framework entirely.
Most MSME units still mid-upgrade
Industry surveys show a large share of small & mid-size pharma units have not completed upgrades; extensions have been requested, with the Ministry reviewing relaxation measures.
Pharmaceutical Quality System is now compulsory
Senior management must own a documented PQS covering CAPA, change control & deviation handling not just a quality manual on paper.
Risk-based validation is the new baseline
Validation Master Plans (IQ/OQ/PQ) and continuous Quality Risk Management are now expected as standard practice, not optional extras.
CDSCO risk-based inspections underway
Thousands of manufacturing plants nationwide face inspection; non-compliant units risk licence suspension, show-cause notices, or plant shutdowns.
Government upgrade support available
The Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) offers subsidies & soft loans to help MSMEs fund the required infrastructure upgrade.
The Payoff
What certification actually changes
Global Market Access
Opens doors to international buyers & semi-regulated export markets.
Schedule M Alignment
Closes the gap with India's own revised GMP legal minimum.
Fewer Recalls
Validated processes reduce product defects & market withdrawals.
Stronger Credibility
Builds trust with regulators, doctors, hospitals & consumers.
Tender Eligibility
A near-standard requirement for hospital & institutional supply tenders.
Inspection-Ready, Always
Ongoing surveillance keeps your plant ready for CDSCO & buyer audits.
Lower Compliance Risk
Reduces exposure to licence suspension or show-cause notices.
Operational Efficiency
Streamlined processes reduce waste & improve batch consistency.
Don't Get Confused
WHO GMP vs other pharma licenses in India
A lot of manufacturers mix this up. Here's exactly how WHO GMP differs from the legal registrations you may already hold.
| Parameter | WHO GMP Certification | Drug Manufacturing Licence (Schedule M) | ISO 9001:2015 | GST Registration |
|---|---|---|---|---|
| Nature | Voluntary international certification | Mandatory statutory licence | Voluntary QMS certification | Mandatory registration |
| Issued by | WHO-recognised / accredited certification body | State Drug Controller / CDSCO | Accredited certification body | GST Department |
| Purpose | Global quality benchmark & market access proof | Legal permission to manufacture drugs | General quality management system | Tax compliance |
| Validity | 2–3 years, witt renewal audits | Renewed periodically per state rules | 3 years + annual audits | No expiry |
| Legal mandate | class="yes">Not compulsory, but export/tender-driven | Compulsory to operate | Not compulsory | Compulsory |
Step By Step
The certification process
From first call to certificate in hand here's exactly how it runs.
Consultation & Gap Analysis
We assess your plant against WHO GMP & revised Schedule M requirements.
Site Master File & Documentation
Quality manual, SOPs & batch documentation drafted for you.
Premises & Equipment Support
Guidance on closing facility, utility & equipment validation gaps.
QRM & Validation (IQ/OQ/PQ)
Risk-based validation plan implemented across critical equipment.
Internal GMP Audit
A pre-certification audit identifies and closes any remaining gaps.
Certification Body Audit
On-site inspection coordinated with an accredited certifying body.
Certificate Issued
WHO GMP Certificate issued, with ongoing surveillance support.
Paperwork, Minimised
Documents you'll need
Drug Manufacturing Licence Copy
Site Master File
List of Products & Dosage Forms Manufactured
Plant Layout & Equipment List
Validation Master Plan (If Available)
QA/QC Standard Operating Procedures
Personnel Qualification & Training Records
Previous Inspection/Audit Reports (If Any)
The SSATAX Difference
Why pharma businesses choose us over other consultants
₹0 service-fee model
You pay only government/certification body fees not inflated "consultant charges."
In-house regulatory experts, not freelancers
Dedicated pharma compliance, legal & documentation teams under one roof.
Real-time human support
Direct WhatsApp & call access to your case handler no bots, no call centres.
Lifetime free consultation
We stay on for renewal reminders & Schedule M regulatory updates, even post-certification.
Proven at scale
1.03 Lakh+ clients, 18,000+ startups served, 5,752+ 5★ Google reviews.
One platform, full compliance
Drug licence support, GST, Trademark & ISO all in one place, not five vendors.
Common Questions
Frequently Asked Questions
Everything you need to know about WHO GMP Certification for Pharmaceutical Manufacturers in India.