(1993; 36 pages)
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.