WHO-GMP compliance, evidenced at the manufacturer, not the trading desk.
Every manufacturer on M Care's roster holds a current WHO-GMP certificate from the CDSCO Zonal office, issued for the specific site and dosage form. Your supplier-qualification pack is assembled against that certificate — not against our letterhead.
WHO TRS 986. CDSCO Zonal inspection. Revised Schedule M.
WHO Good Manufacturing Practices is the common vocabulary procurement teams use to qualify an Indian manufacturer. The framework is the WHO Technical Report Series; the inspecting authority for Indian exporters is CDSCO; and the Indian statutory GMP schedule, Schedule M, was revised on 28 December 2023 to align closely with TRS 986.
What WHO-GMP requires
The core guide is WHO TRS 986 Annex 2 — the main principles of GMP for pharmaceutical products. It sets out quality management, personnel, premises, equipment, documentation, production, quality control, complaints and recalls, self-inspection, and contract manufacture. Ancillary annexes cover HVAC (TRS 999 Annex 2), storage and distribution (TRS 992 Annex 5), biologicals (TRS 961 Annex 3), and data integrity under TRS 996 Annex 5.
CDSCO's role
The Central Drugs Standard Control Organization, India, is the competent authority that inspects Indian manufacturing sites against Schedule M and issues the WHO-GMP Certificate and the Certificate of Pharmaceutical Product (CoPP) in the WHO-recommended format. Certificates are site-specific and dosage-form-specific, usually valid three years, and triggered for reinspection on renewal or WHO-PQ.
What Revised Schedule M changed
The Government of India notified Revised Schedule M on 28 December 2023. It tightens pharmaceutical quality system expectations, data integrity, product quality review, and qualification of utilities — close-aligned to TRS 986. Manufacturers with turnover above INR 250 crore have been in force since 28 June 2024; smaller sites are on a phased deadline. Every site on our roster has mapped the gap and closed it.
When a buyer asks for the WHO-GMP pack.
Ministry of Health tender
A Saudi, Kenyan or Iraqi MoH tender desk issuing a formulary tender will list WHO-GMP and CoPP among the mandatory bid attachments. We pull the current certificate for the nominated site and dosage form, check residual validity, and ship the notarised set inside the tender deadline.
NGO donor QA
Global Fund, UNICEF, MSF and donor-funded procurement programmes apply their own supplier-qualification QA on top of WHO-GMP. The pack includes site master file summary, product dossier cross-references, and a data-integrity self-assessment against ALCOA+ principles.
EU importer first-time audit
A licensed importer in Germany or France qualifying a new Indian site for commercial supply will typically request a virtual or onsite audit before the first purchase order. The Mumbai desk coordinates the date window, shares the site master file in advance, and hosts the auditor's question set at the factory.
Post-shortage emergency supply
When a European or African hospital system hits a critical shortage, procurement needs a WHO-GMP-certified alternative source quickly — but still qualified properly. A rapid WHO-GMP evidence bundle can be on the buyer's desk within one working day, so the clinical committee's sign-off is not the bottleneck.
What lands in the buyer's inbox.
Each item is pulled from the manufacturer's live QMS, current-dated, and cross-checked by the Mumbai desk before it leaves India. The pack is scoped to the molecule, dosage form and site your tender or audit is qualifying.
WHO-GMP certificate
Current CDSCO-issued WHO-GMP certificate for the specific manufacturing site and the specific dosage form. Residual validity verified — a minimum of six months remaining at the point of shipment or bid submission.
CoPP in WHO format
Certificate of Pharmaceutical Product issued by CDSCO in the WHO-recommended format. Apostilled at the Indian Ministry of External Affairs where the destination country's consulate or tender desk requires it for legalisation.
Site master file summary
An SMF extract prepared to the WHO-PQ template: site activities, organisation chart, personnel qualification, premises and utility qualification, production flow, and a QC laboratory narrative. Full SMF available on CDA for onsite audits.
Validation master plan excerpt
The VMP section covering process validation, cleaning validation, analytical method validation and computerised system validation. Paraphrased under WHO supplementary validation guidance (TRS 937 Annex 4 or later edition) and the manufacturer's internal SOPs.
Data-integrity self-assessment
A self-assessment against ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) and WHO TRS 996 Annex 5. Includes audit-trail review status for HPLC, dissolution and LIMS systems.
Recent inspection summary
A summary of the most recent CDSCO inspection, client audit or WHO-PQ visit — date, scope, outcome, and CAPA close-out status. Redacted where a client-specific NDA applies, but the top-line compliance position is always shareable.
Site fit → pack → audit → close-out → renewal.
- Site selection against the specification. The Mumbai desk matches the molecule, dosage form, volume and destination market against the WHO-GMP partner sites that hold the right certificate scope and capacity. Shortlist of one to three sites back to the buyer within one working day.
- Supplier-qualification pack assembled. WHO-GMP certificate, CoPP, SMF summary, VMP excerpt, data-integrity self-assessment and recent inspection summary pulled from the manufacturer's QMS, current-dated and sent as a single indexed pack under CDA.
- Virtual or physical audit coordination. Where the buyer's QA requires an audit, the desk coordinates the date window, pre-audit question set, site travel and interpretation. Virtual audits hosted on the manufacturer's conferencing with a live shop-floor video feed.
- Inspection close-out and CAPA. Any observations are categorised critical, major or minor. A CAPA plan with target dates and evidence packages is issued within 30 days of the audit and tracked to close by the manufacturer's Head of Quality and the Mumbai desk.
- Ongoing change control and renewal. Certificate expiries, Schedule M phased deadlines and any site change controls are tracked on a buyer-specific timeline. Renewal dossiers and re-inspection reports are pushed to the buyer's QA ahead of each commercial shipment window.
WHO-GMP supplier qualification — the specifics.
Is M Care itself WHO-GMP certified?
No — and we will not claim that it is. WHO-GMP attaches to a manufacturing site inspected by a competent authority, not to a trading and export company. M Care is a CDSCO-licensed exporter and the commercial-and-regulatory arm for the Indian manufacturers on our roster. WHO-GMP certificates in your supplier-qualification pack are issued in the manufacturer's name, for the specific site and dosage form, by the CDSCO Zonal office that inspects it.
How many WHO-GMP sites are on the roster?
Over 80 WHO-GMP partner manufacturing sites across India, covering 18 therapeutic categories, 600+ active ingredients and 10,173+ SKUs. The site matched to your enquiry depends on the molecule, dosage form (oral solid, sterile injectable, ophthalmic, topical, biological), destination market and required volume band. Shortlist comes back to you with the scope of each site's WHO-GMP certificate clearly stated.
Can you share a WHO-GMP certificate before a purchase order?
Yes. Under a mutual CDA, the current WHO-GMP certificate for the nominated site and dosage form is shared as a scanned PDF with residual validity, inspection date, and certificate number visible. A notarised hard copy or MEA-apostilled copy follows if your tender or importer Responsible Person requires it.
What is Revised Schedule M and does it affect supply?
Revised Schedule M was notified by the Government of India on 28 December 2023. It updates the Indian statutory GMP schedule under the Drugs and Cosmetics Rules 1945 and aligns it closely to WHO TRS 986 — tighter expectations on the pharmaceutical quality system, data integrity, product quality review, and qualification of utilities. It has been in force since 28 June 2024 for manufacturers with turnover above INR 250 crore; smaller sites are on a phased deadline. Every site on our roster has mapped the gap and closed it, and the compliance position is declared in the supplier-qualification pack.
What is the difference between WHO-GMP and WHO-PQ?
WHO-GMP is the Good Manufacturing Practices standard that CDSCO inspects Indian sites against, issuing a site-and-dosage-form specific certificate. WHO Prequalification (WHO-PQ) is a separate WHO-run programme that inspects the site against TRS 986 plus specific PQ requirements and then lists the individual product on the WHO Prequalification List. A site can be WHO-GMP certified without being WHO-PQ listed for a given product. We hold both statuses across the roster; the tender or donor requirement determines which route applies.
What happens if a site fails an inspection?
A critical observation triggers immediate halt of supply of the affected dosage form from that site until the CAPA is closed. In that case the Mumbai desk switches production to an alternative WHO-GMP site on the roster holding the same certificate scope, so the buyer's supply continuity is not dependent on a single facility. The inspection outcome, CAPA plan and close-out evidence are disclosed to any buyer with an active supplier-qualification record for that site.
Can our team audit the manufacturing site?
Yes. Onsite audits at the Indian facility are standard for first-time qualification and typically repeat annually for qualified suppliers. Virtual audits are supported with a live shop-floor video feed and remote document review. The desk coordinates date windows, pre-audit questionnaires, auditor travel, interpretation, and audit-report circulation. See NGO / donor procurement for the audit pattern used by Global Fund and UNICEF-funded buyers.
How is data integrity ensured at the manufacturer?
Against ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available) — the framework reflected in WHO TRS 996 Annex 5. HPLC, dissolution, stability-chamber and LIMS systems are audit-trail enabled, user-access controlled and periodically reviewed. A data-integrity self-assessment is part of the supplier-qualification pack, and any findings from the annual self-inspection required under TRS 986 Chapter 9 are disclosed to qualified buyers on request.
Nominate a molecule, a market, a deadline. We'll bring the site.
Tell us the dosage form, the destination regulator and the tender or audit window. A WHO-GMP-matched site shortlist and the first cut of the supplier-qualification pack reach you within one working day.