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
 

3.2 Radiopharmaceuticals

The Committee was informed that The International Pharmacopoeia contained only general methods for the analysis of radiopharmaceuticals; there were no individual monographs for such products, mainly because they were not on the WHO Model List of Essential Drugs. The Committee discussed a proposal to either retain or delete the general methods for the analysis of radiopharmaceuticals, and/or to prepare specific monographs for them. The Committee recommended that the general methods of analysis should be deleted from The International Pharmacopoeia and that a separate publication on radiopharmaceuticals (independent of The International Pharmacopoeia) should be prepared in collaboration with the International Atomic Energy Agency (IAEA). It was also agreed that, at a future meeting of the Committee, it should be decided whether these newly developed monographs for radiopharmaceuticals should be kept separate from, or again included in, The International Pharmacopoeia.

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