WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report
(2003; 148 pages) View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. General policy
Open this folder and view contents3. Quality control - specifications and tests
View the document4. Quality control - international reference materials
Open this folder and view contents5. Quality control - national laboratories
Open this folder and view contents6. Quality assurance - good manufacturing practices
Open this folder and view contents7. Quality assurance - inspection
Open this folder and view contents8. Quality assurance - distribution and trade-related
Open this folder and view contents9. Quality assurance - risk analysis
Close this folder10. Quality assurance - drug supply
View the document10.1 Procedure for assessing the acceptability for purchase of pharmaceutical products
View the document10.2 Procedure for assessing the acceptability for purchase of pharmaceutical products for the treatment of HIV/AIDS
Open this folder and view contents11. Quality assurance - storage
View the document12. International Nonproprietary Names (INNs) programme
Open this folder and view contents13. Miscellaneous
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 Recommendations on risk of transmitting animal spongiform encephalopathy agents via medicinal products
View the documentAnnex 2 The International Pharmacopoeia: revised concepts and future perspectives
Open this folder and view contentsAnnex 3 Guidelines on Good Manufacturing Practices for radiopharmaceutical products
Open this folder and view contentsAnnex 4 Good Manufacturing Practices for pharmaceutical products: main principles
View the documentAnnex 5 Model certificate of Good Manufacturing Practices
View the documentAnnex 6 Guidance on Good Manufacturing Practices (GMP): inspection report
View the documentAnnex 7 Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals
Open this folder and view contentsAnnex 8 Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies
Open this folder and view contentsAnnex 9 Guide to good storage practices for pharmaceuticals1
View the documentBack cover
 

10.2 Procedure for assessing the acceptability for purchase of pharmaceutical products for the treatment of HIV/AIDS

The Committee was informed of WHO’s pilot project, in conjunction with the United Nations Children’s Fund (UNICEF), the Joint United Nations Programme on HIV/AIDS (UNAIDS), and the United Nations Population Fund (UNFPA), together with the support of the World Bank, to test the system for the pre-qualification of suppliers of drugs for the treatment of HIV/AIDS. This included: (1) evaluation of the dossier; (2) provision of samples for analysis; and (3) inspection of the manufacturing site. Only manufacturers of dosage forms would be subject to inspection under this programme (manufacturers of active pharmaceutical ingredients would not be inspected at this time but such inspections are not excluded in the future). The Committee was briefed on the number of quality defects found in the course of this project, and recommended that every effort should be made to ensure budgetary support for its continuation.

 

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