WHO prequalification

WHO prequalification is a service provided by the World Health Organization (WHO) that checks whether medical products and laboratories are acceptable for international procurement. It gives United Nations (UN) agencies and global health partners a verified basis for purchasing decisions, so medicines and testing facilities can be judged against rigorous safety and quality expectations.

WHO prequalification covers products, ingredients, and quality control laboratories

The program assesses finished pharmaceutical products, active pharmaceutical ingredients (the raw chemical materials), and quality control laboratories. For a laboratory, prequalified status requires a documentation review and an on-site inspection by a team that includes a PIC/S (Pharmaceutical Inspection Co-operation Scheme) inspector.

The laboratory must show that it follows the WHO Good Practices for Quality Control Laboratories. The review looks at its competence to perform chemical and microbiological testing of medicines. After acceptance, the laboratory must submit annual reports and keep complying with the requirements; failure can lead to delisting.

For someone reviewing a lab report, WHO prequalification of the testing facility is a high-level quality signal. It means a Certificate of Analysis from that facility carries more regulatory weight than one from an unvetted laboratory.

WHO prequalification is distinct from related quality concepts

• ISO/IEC 17025 vs. prequalification: ISO/IEC 17025 accreditation is a mandatory prerequisite for laboratory prequalification, not an equivalent or alternative.
• GMP certification: Good Manufacturing Practice focuses on manufacturing processes, while prequalification assesses analytical testing competence.
• Product vs. laboratory status: Laboratory prequalification is separate from prequalification of a specific pharmaceutical product; one does not automatically imply the other.

Sources

1. Prequalification Procedures and Fees: FPPs, APIs & QCLs | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
2. Prequalification of health products
3. What We Do | WHO - Prequalification of Medical Products (IVDs ...
4. Annex 10 Procedure for prequalifi cation of pharmaceutical products
5. Assessment | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
6. Finished pharmaceutical products | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
7. Full Assessment – Multisource (Generic) FPPs | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
8. Quality Control Laboratories for Medicines | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
9. Active Pharmaceutical Ingredients | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
10. Laboratories | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
11. Annex 3
12. How does medicines prequalification work? | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
13. OVERVIEW OF THE PREQUALIFACTION ASSESSMENT PROCEDURE
14. TRS-970-pdf1.pdf0"0
15. Quality Control Laboratories | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
16. Post-prequalification Procedures and Fees: APIs, FPPs and QCLs | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
17. API Master File (APIMF) Procedure | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
18. Medicines | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
19. Assessment of Laboratories for Accreditation - Extranet Systems
20. Laboratory Accreditation for Product Testing | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
21. Accreditation Process | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
22. Impact of ISO/IEC 17025 laboratory accreditation in sub-Saharan Africa: a case study
23. Performance Evaluation | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
25. Norms and Standards Setting | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
27. [PDF] Annex 1 WHO good practices for pharmaceutical quality control ...
28. Global GMP Standards: Comparing FDA, EU, WHO, and Beyond
29. Medicines | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)