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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
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
 

1. Introduction

The WHO Expert Committee on Specifications for Pharmaceutical Preparations met in Geneva from 22 to 26 October 2001. The meeting was opened on behalf of the Director-General by Dr Y. Suzuki, Executive Director, Health Technology and Pharmaceuticals, who said that, since the last meeting of the Committee, there has been more evidence of globalization and the harmonization of specifications for pharmaceutical preparations, especially for pharmaceuticals used in the treatment of HIV, tuberculosis and malaria. WHO was committed to helping to ensure the quality of pharmaceuticals and to treat these diseases.

Dr J.D. Quick, Director, Essential Drugs and Medicines Policy, briefed the Committee on the WHO strategy for medicines, which focuses on:

- ready access to essential medicines at affordable prices;
- quality and safety of such medicines;
- rational drug use;
- effective national drug policies.


It was intended that the information arising from the meeting would be readily available through the WHO web site and through the “Global Medicines Family”.

Dr L. Rägo, Coordinator, Quality Assurance and Safety: Medicines (QSM), informed the Committee about the wide range of activities undertaken by the QSM team. A substantial number of countries were now using the WHO good manufacturing practices (GMP) guide and there was greater cooperation with WHO collaborating centres.

 

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