Overview

Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard products still compromise health-care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. More than 75 relevant international guidelines, standards and good practices endorsed by the Committee are reproduced in this volume, providing guidance covering all aspects of quality assurance including good manufacturing practices (GMP).

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World Health Organization is a Specialized Agency of the United Nations, charged to act as the world's directing and coordinating authority on questions of human health. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends.

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