WHO-GMP Certified Pharmaceutical Manufacturer (Pune, India)
The WHO-GMP certificate is the minimum quality threshold for selling APIs into any regulated market. Ours has been renewed annually since 2014 — and we layer ISO 9001:2015, FDA DMF Type II, and EDQM CEP on top so buyers in the US, EU, LATAM, and APAC can audit against any framework their own regulator recognises.
What WHO-GMP actually means for a buyer
WHO Good Manufacturing Practice is the consensus quality standard set by the World Health Organization for active pharmaceutical ingredient manufacturers. A WHO-GMP certificate confirms:
- A documented Pharmaceutical Quality System (PQS) compliant with ICH Q10.
- Validated manufacturing processes and qualified equipment (IQ/OQ/PQ).
- Trained personnel with documented job competence.
- Controlled facilities and clean-room areas with environmental monitoring.
- Risk-based change control and CAPA processes.
- Full batch traceability from raw material to finished API release.
Buyers selling into regulated markets cannot file an ANDA, MA, or equivalent without an API source that holds the relevant GMP certification.
What buyers can audit during a site visit
We host an average of 30 buyer audits per year — a mix of qualification audits (new supplier qualification), surveillance audits (annual confirmation), and for-cause audits (post-deviation root cause). The documents and areas auditors typically review:
- QMS — Quality Manual, SOPs, training records, deviation logs, CAPA register, change-control log.
- Production — batch manufacturing records, in-process control charts, line-clearance logs, equipment cleaning records.
- QC laboratory — analytical methods, OOS investigations, stability data, reference standards inventory.
- Validation — process validation, cleaning validation, computer-system validation (21 CFR Part 11 where applicable).
- Facilities — HVAC qualification, water-system data, environmental monitoring trends.
Audit packs are pre-assembled and made available read-only on a customer portal before the on-site visit so auditors can pre-mark questions and shorten the on-site time.
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Frequently asked questions
How recent is your most recent WHO-GMP renewal?
Our current WHO-GMP certificate was renewed in Q4 2025 by the WHO Prequalification Inspection Team. The certificate is valid for 36 months from renewal and is available on request — please contact us for a PDF copy with the inspector signature.
How quickly can we schedule an audit?
Buyer audits are scheduled with 4-6 weeks lead time. We block audits to specific weeks per quarter so the production team can prepare batch records and shop-floor staff. Emergency for-cause audits can typically be accommodated within 2 weeks.
Do you allow video/remote audits?
Yes — we’ve hosted multiple remote audits since 2020. Live shop-floor walks via head-cam, document review via screen-share, and full Q&A sessions can all be done remotely. Some regulators still prefer on-site for first-time qualification.
Talk to a sales engineer
First response within 4 business hours, Pune time (IST). We can also run a teams call inside your working hours — most weekday hours across the US, EU, LATAM and APAC are covered.