WHO Expert Committee on Specifications for Pharmaceutical Preparations

Good manufacturing practices for pharmaceutical products. In WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report. Geneva, World Health Organization, 1992 (WHO Technical Report Series, No. 823, Annex 1). 

WHO. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Geneva World Health Organization, 2004. 

The WHO was established in 1948 as a specialized agency of the United Nations (UN). Its purpose is to serve as the directing and coordinating authority for international health matters and public health. One of the main functions of the WHO is to provide objective and reliable information and advice in the field of human health, a task that it partly fulfills through WHO publications [35]. The first WHO draft text on GMP was prepared in 1967 and a revised version was published in 1968 as an annex of the twenty-second report of the WHO expert committee on specifications for pharmaceutical preparations. Over the years the WHO has issued several versions of its GMP guidelines as well as other guidelines related to the GMP and quality issues of the production of therapeutic products. The latest version of the WHO GMP guideline was published in 2003 as an annex of the WHO Technical Report 908 [36]. 

World Health Organization (WHO) (2006), WHO expert committee on specifications for pharmaceutical preparations (fortieth report)—Supplementary guidelines on good manufacturing practices (GMP) Validation, WHO, Geneva. 

It must be recalled that the World Health Organization (WHO) perceived the International Pharmacopoeia as a means of harmonizing quality specifications of pharmaceutical substances internationally. As long as WHO efforts are not given any legal status per se as they are, at best, mere recommendations, then other steps have to be found to affirm quality. It must be stated however that in 1981 the WHO Expert Committee on Specifications for Pharmaceutical Preparations reviewed the whole system and came out with its Twenty-Eight Report with clearly defined functions and characteristics of the International Pharmacopoeia. 

They may be issued by an individual WHO Expert Committee and included in their reports (e.g., WHO Expert Committee on specifications for pharmaceutical preparations, technical report number 863, 1996), or issued as special WHO publications under the authority of the DG (e.g.. Globalization and access to drugs, health economics and drugs, 1998). Most of the WHO Recommendations are directed at developing countries (e.g., the International Pharmacopoeia ). 

The WHO Expert Committee on Specifications for Pharmaceutical Preparations met in Geneva from 24 to 28 October 2005. Dr Hans V Hogerzeil, Director, Policy of Medicines and Standards, welcomed the Committee members and other participants on behalf of the Director-General, Dr LEE Jong-wook, and the Assistant Director-General, Dr Vladimir K. Lepakhin. 

International Chemical Reference Substances (ICRS) are established upon the advice of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. They are supplied primarily for use in physical and chemical tests and assays described in the specifications for quahty control of medicines published in The International Pharmacopoeia or proposed in draft monographs. The International Chemical Reference Substances are mainly intended to be used as primary standards to calibrate secondary standards. 

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