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WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report
(1993; 36 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. The international pharmacopoeia and related activities
Open this folder and view contents3. International Chemical Reference Substances and International Infrared Reference Spectra
View the document4. Quality control methods for medicinal plant materials
View the document5. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Open this folder and view contents6. Good manufacturing practices for pharmaceutical products
View the document7. Development of globally acceptable standards for excipients
Open this folder and view contents8. Stability of dosage forms
View the document9. Simple test methodology
View the document10. Quality assurance in pharmaceutical supply systems
Open this folder and view contents11. Pharmaceutical production in developing countries
View the document12. Training
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 - List of available International Chemical Reference Substances1
View the documentAnnex 2 - List of available International Infrared Reference Spectra
Open this folder and view contentsAnnex 3 - Good manufacturing practices for biological products1
View the documentBack Cover
 

10. Quality assurance in pharmaceutical supply systems

Much of the advice and guidance concerning the quality of pharmaceutical products provided by WHO publications is addressed primarily to drug regulators. It is recognized, however, that many different organizations and individuals are concerned with one or more aspects of the supply of pharmaceutical products and therefore need to understand the concept of quality assurance and its application to pharmaceutical supply systems. The Committee therefore recommended that WHO should consider preparing guidelines for use by organizations and individuals involved in the supply or receipt of purchased or donated pharmaceutical products.

In this context, the Committee took note of guidelines for donors and recipients of pharmaceutical products and guidelines on drug procurement practice prepared respectively by the Christian Medical Commission of the World Council of Churches and the International Pharmaceutical Federation (8,9). These helpful documents, together with others such as the WHO document listing requirements for an emergency health kit (10), could be taken into account in developing authoritative guidance. Appropriate United Nations agencies and nongovernmental organizations should be consulted with the aim of harmonizing policies, for example on the donation of pharmaceutical products.

Within the same general context the Committee endorsed the Secretariat’s proposal to develop guidelines on import procedures for pharmaceutical products. Such guidelines would be prepared in consultation with the Customs Co-operation Council, the International Narcotics Control Board and other relevant bodies. It was recognized that the point of entry of products into a country was a key step in the distribution chain. Guidance in this area would complement initiatives such as the joint WHO/UNICEF study referred to in section 8.1.

 

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