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). This 2014 edition newly includes - an updating mechanism for the section on radiopharmaceuticals of The International Pharmacopoeia; - an update of the main principles of the WHO good manufacturing practices for pharmaceutical products; - an update of the Model quality assurance system for procurement agencies, with a newly designed model inspection report and an update of the product questionnaire; - a new assessment tool, aide-memoire for inspection, based on the model quality assurance system for procurement agencies; - new guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part; and - new guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities. This CD-ROM also includes a study pack with a huge set of training materials reflecting the various GXP texts, good practices for manufacturing and quality control.

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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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