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
Close this folder3. Quality control - specifications and tests
View the document3.1 Thin-layer chromatography screening tests for antimalarials
View the document3.2 Radiopharmaceuticals
View the document3.3 Pharmacopoeial monographs on antiretrovirals
View the document3.4 Thin-layer chromatography screening tests for antituberculosis drugs
View the document3.5 Draft monograph on rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride tablets
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
Open this folder and view contents10. Quality assurance - drug supply
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
 

3.3 Pharmacopoeial monographs on antiretrovirals

The Committee adopted the recommendations on the development of pharmacopoeial monographs on antiretrovirals made during a consultation held in Geneva in September 2001, but advocated that the Secretariat should review the list of substances and products in accordance with the new treatment pattern regimen. For a number of antiretrovirals, manufacturers’ specifications are available. The Committee therefore recommended that WHO should seek information from additional manufacturers willing to collaborate. It was suggested that national authorities with experience in evaluating and testing new antiretrovirals should be asked for their support. This also applies to the possibility of obtaining samples.

The following recommendations were made by the Expert Committee:

• Since the development and validation of analytical methods and requirements (including screening tests and pharmacopoeial monographs) as well as the establishment of International Chemical Reference Substances will require a significant budget, the possibility of obtaining financial support should be investigated.

• The development of quality specifications for substances and pharmaceutical products including one active pharmaceutical ingredient should be given priority.

• The collaboration of the PDG should be sought in elaborating monographs on antiretrovirals.

 

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