[e-drug] Just published: WHO CD-ROM Quality Assurance of Pharmaceuticals.

e-drug
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E-DRUG: Just published: WHO CD-ROM Quality Assurance of Pharmaceuticals.
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Update 2015
WHO guidelines, good practices, related regulatory guidance and GXP training materials
This 2015 edition newly includes:

  - Procedure of the development of monographs for inclusion in The International Pharmacopoeia (revision);
  - Updating mechanism for the section on radio-pharmaceuticals in The International Pharmacopoeia (revision);
  - Supplementary guidelines on Good Manufacturing Practices (GMP): validation; Appendix 7: non-sterile process validation (revision);
  - General guidance for inspectors on "hold-time" studies (new);
  - Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients (revision);
  - Guidelines on registration requirements to establish interchangeability (revision);
  - Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products (revision);
  - Good review practices guidelines for regulatory authorities (new).

In addition, 16 technical supplements to the WHO model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products were included in this new CD-ROM together with a summary outlining the details of these new supplements.

This CD-ROM also includes a study pack with a huge set of training materials reflecting the various GXP texts, including those for Good Manufacturing Practices (GMP) and quality control.

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 more at:

http://www.who.int/medicines/areas/quality_safety/quality_assurance/en/ and
http://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/en/

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).

ISBN 978 92 4 154931 8
CHF 150.00/US$ 180.00
In developing countries: CHF 105.00/
US$ 126.00
Order no. 19900062
Order online: www.who.int/bookorders<http://www.who.int/bookorders&gt;

Dr Sabine Kopp | Group Lead, Medicines Quality Assurance |
HIS/EMP/RHT/TSN | Technologies Standards and Norms |
Regulation of Medicines and Other Health Technologies |
Essential Medicines and Health Products | World<http://www.rijksoverheid.nl/ministeries/vws&gt; Health Organization |
20, Avenue Appia, CH-1211 Geneva 27 | Switzerland
"KOPP, Sabine" <kopps@who.int>