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
Close this folder2. General policy
View the document2.1 Specifications for medicinal plant materials and for herbal products
View the document2.2 Risk of transmitting animal spongiform encephalopathy agents via medicinal products
View the document2.3 Stop TB programme
View the document2.4 Roll Back Malaria programme
View the document2.5 HIV/AIDS programme
View the document2.6 Future of The International Pharmacopoeia
View the document2.7 Pharmacopoeial Discussion Group (PDG)1
View the document2.8 International Conference on Harmonisation (ICH)
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
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
 

2.6 Future of The International Pharmacopoeia

The Committee was informed of the new WHO strategy for a global step-wise approach to the quality control of pharmaceuticals, including basic tests, screening tests, and monographs in The International Pharmacopoeia. The development of new monographs for The International Pharmacopoeia would give priority to the needs of specific disease programmes and the essential drugs nominated under these programmes.

The Committee confirmed that The International Pharmacopoeia continued to fulfil a need in developing countries. While it contains monographs with stringent specifications, it also provides equally acceptable but less technically demanding alternative methods for specific substances and preparations wherever possible.

At an informal consultation held in Geneva on September 2001, the uniqueness of WHO’s role in developing global standards was emphasized and the global and step-wise approach to the quality control of pharmaceuticals and the list of priorities given in this document were strongly supported.

The following recommendations were made by the Expert Committee:

• In the light of the increasing shift to more sophisticated methods and international proposals to introduce more stringent test limits, The International Pharmacopoeia and related activities should be strengthened and promoted.

• The approach recently adopted whereby alternative test specifications are included in new monographs for The International Pharmacopoeia should be maintained.

• The title of The International Pharmacopoeia should be maintained.


The Committee adopted the recommendations and the relevant document entitled “The International Pharmacopoeia: revised concepts and future perspectives” (Annex 2). The Committee also agreed that the survey of the use of The International Pharmacopoeia conducted 5 years ago should be repeated, and advocated that The International Pharmacopoeia should be promoted more effectively.

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