Ensuring the Quality of Medicines in Resource-Limited Countries: An Operational Guide
(2007; 207 pages)


The Guide was developed through a collaborative effort among the USP Drug Quality and Information Program; Department of Medicines Policy and Standards of the World Health Organization; Rational Pharmaceutical Management Plus Project; Program for Appropriate Technology in Health; Organon Pharmaceuticals; and the national medicines regulatory authorities of Malaysia, Uganda, Vietnam, and Zimbabwe. Since 1820, USP has established the official standards of quality, purity, strength, and labeling for medicines used in the United States and Canada; today these standards are used in many other countries as well. The USP Drug Quality and Information program is a cooperative agreement between USP and USAID to build local capacity in medicines quality assurance and control and in medicines information development and dissemination. USP has worked with USAID since 1992; the partnership now provides technical assistance to more than 25 developing countries. All partners involved in drafting this Guide were invited to participate because they have expertise in supply management, quality control, national health programs, and national medicines policy development. It has been a wonderful group with whom to work - enthusiastic, committed, and talented. One obstacle the authors encountered was their many locations scattered around the world. Would the authors merely draft their assigned chapters in isolation and submit them for inclusion in a textbook-style document, or should there be a group process of designing, developing, and reviewing the manual that would incorporate the expertise of all the authors into the style and objectives of the Guide? The latter path was taken, and through electronic mail, conference calls, and periodic group writing workshops, this Guide was created. Ideally, it expresses the viewpoints of all authors - many of whom have direct experience in addressing the various problems of ensuring medicines quality in different environments and at different levels - international, regional, national, and local...

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