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Quality assurance of pharmaceuticals
WHO guidelines, related guidance and GXP training modules
2014

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, spurious, falsified and counterfeit 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 70 relevant documents endorsed by the Committee are reproduced in this volume, providing guidance covering all aspects of quality assurance including good manufacturing practices (GMP). This CD-ROM in addition includes a study pack with a huge set of GXP training materials.

Joint update of the following three CD-ROMs:

Quality assurance of pharmaceuticals
WHO guidelines, related guidance and GXP training modules
World Health Organization
2013
Quality assurance of pharmaceuticals
A compendium of guidelines and related materials
World Health Organization
2011
WHO Training Modules on Good Manufacturing Practices (GMP)
A resource and study pack for trainers. Second edition
World Health Organization
2007
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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
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About this CD-ROM
 
This CD-ROM was produced by the WHO Medicines Quality Assurance Programme 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, 2014