WHO-GMP
WHO-GMP support for pharmaceutical manufacturers targeting regulated and export markets.
We help assess your pharmaceutical manufacturing facility against WHO-GMP guidelines, close documentation and process gaps, and prepare you for certification.
What is WHO-GMP?
WHO-GMP refers to the Good Manufacturing Practice guidelines published by the World Health Organization, widely used as a benchmark for pharmaceutical manufacturing quality — particularly relevant for exporters supplying markets that reference WHO-GMP as a baseline requirement.
It is distinct from generic GMP certification: WHO-GMP applies specific pharmaceutical manufacturing, quality-control and documentation requirements, and in India is generally assessed alongside the manufacturer's statutory drug manufacturing licence.
Certification/attestation involves the relevant accredited certification body or drug regulatory authority, depending on the jurisdiction and buyer requirement. Gurur Consultancy helps you assess current practices against WHO-GMP guidelines, build the required documentation, and prepare for the assessment — we do not issue drug licences or WHO-GMP certificates ourselves.
Why this matters for your business
Who typically needs WHO-GMP?
Applicability varies by business — here’s who this usually applies to.
- Pharmaceutical formulation and manufacturing units
- Contract manufacturers producing pharmaceutical products for other brands
- Exporters of pharmaceutical products targeting markets that reference WHO-GMP
Eligibility & requirements
- Applicable to licensed pharmaceutical manufacturing facilities
- A valid drug manufacturing licence from the applicable regulatory authority is a prerequisite we help you confirm is in place
Documents & information
Commonly required documents may include:
How we take this forward
- 01
Facility & Documentation Review
We assess your current manufacturing practices and documentation against WHO-GMP guidelines.
- 02
Gap Identification
Process, quality-control and documentation gaps specific to WHO-GMP expectations are identified.
- 03
Documentation & SOP Development
We help build or refine the SOPs, batch records and quality-control procedures required.
- 04
Implementation
Updated procedures are applied in production and monitored.
- 05
Assessment/Audit
The relevant accredited certification body or drug regulatory authority audits the facility.
- 06
Certification Issued
On successful assessment, WHO-GMP certification/attestation is granted, subject to periodic renewal.
Our approach to WHO-GMP
End-to-End Support
One partner from idea to registration to tender win.
Practical Guidance
Plain-language advice from people who have filed thousands of cases.
Documentation Support
Right documents, right format, right the first time.
Compliance-Focused Approach
We don't just register — we keep you compliant.
Government Procurement Expertise
We know GeM, CPP and tender portals inside-out.
Long-Term Business Support
We grow with you — from proprietorship to private limited.
Frequently asked questions
You may also need
Need Help With WHO-GMP?
Tell us about your manufacturing licence and target export markets, and we'll outline the WHO-GMP readiness steps.