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Quality assurance of pharmaceuticals 2019
WHO guidelines, good practices, related regulatory guidance
and GXP training materials

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 90 relevant international guidelines, standards and good practices endorsed by the Committee and reproduced in this volume, providing guidance covering all aspects of quality assurance including good manufacturing practices (GMP).

Please click here for details on the
Procedure for the development of World Health Organization medicines quality assurance guidelines

This publication also includes a study pack with a huge set of training materials reflecting the various GXP texts, good practices for manufacturing and quality control.

All WHO medicines quality assurance guidelines are included in the following groupings:

· Development of pharmaceutical products
· Distribution
· Inspections
· Production
· Quality control
· Related regulatory standards
All WHO GXP training modules are included in the following groupings:

· Good Manufacturing Practices (GMP) training modules
· Laboratory related training modules
 GMP video supplementary document

Copyright and Cataloguing-in-Publication Data


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Joint update of the following CD-ROMs:

Quality assurance of pharmaceuticals
Quality assurance of pharmaceuticals
Quality assurance of pharmaceuticals
Quality assurance of pharmaceuticals
Quality assurance of pharmaceuticals
Quality assurance of pharmaceuticals
Quality assurance of pharmaceuticals
WHO Training Modules on Good Manufacturing Practices (GMP)
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About this CD-ROM
This CD-ROM was produced by the WHO Medicines Quality Assurance Group with the help of Human Info NGO/WIT and its logistic partner HumanityCD Ltd, and the University of Waikato, New Zealand, using the Greenstone software of the New Zealand Digital Library. It also includes Mozilla Firefox, distributed by Human Info NGO/WIT.
© World Health Organization, 2019