E-DRUG: CD-ROM: Quality Assurance of Pharmaceuticals. Update 2014
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WHO guidelines, related guidance and GXP training materials
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 medicines quality assurance throughout the life-cycle of a medicine, from its development to the supply to the patient.
This new 2014 edition 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.
The CD-ROM is available from
WHO Press, 1211 Geneva 27, Switzerland
Tel +41 22 791 32 64 - Fax +41 22 791 48 57 -
Email: bookorders@who.int
Website: http://www.who.int/bookorders
With kind regards,
Dr Sabine Kopp
Group Lead, Medicines Quality Assurance
Technologies Standards and Norms
Regulation of Medicines and Other Health Technologies
Essential Medicines and Health Products
World Health Organization
"KOPP, Sabine" <kopps@who.int>