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Sourcing WHO-GMP Certified Generics: What International Buyers Should Verify

18 September 2026By Tuli Enterprise Export Team

A checklist for importers to confirm they are buying genuinely WHO-GMP certified medicines — the certificates, documents and quality signals that matter.

“WHO-GMP certified” is one of the most important quality signals in global pharmaceutical trade — but buyers should know how to verify it. Use this checklist before you commit to any supplier.

1. Confirm the certification belongs to the manufacturing facility

WHO-GMP is a manufacturing certification held by the factory that produces the medicine, not by a trading company. Always ask which facility manufactures each product and request that facility’s valid GMP certificate.

2. Request the core documents

  • WHO-GMP certificate — current and covering the relevant dosage form.
  • COPP — Certificate of Pharmaceutical Product, ideally in WHO format.
  • COA — batch-specific Certificate of Analysis.
  • Free Sale Certificate — confirming the product is marketed in the country of origin.

3. Check stability data for your climate zone

Products destined for hot, humid markets should carry stability data for Zone IVa/IVb. Ask for the stability summary.

4. Look for stringent-regulator alignment where relevant

For higher-tier tenders, facilities with EU-GMP, PIC/S or other stringent-regulator approvals add assurance. Learn more about the certifications behind our products.

5. Assess documentation responsiveness

A reliable partner provides documents quickly and completely. Slow or incomplete paperwork is a red flag for later registration and customs problems.

Source with confidence

Every product we export is sourced from WHO-GMP certified facilities and supplied with full documentation. Request a quote with your requirements.

Need a supplier for this market?

Tuli Enterprise supplies WHO-GMP certified generics and nutraceuticals worldwide with full registration and export documentation.

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