WHO EXPERT COMMITTEE

1 WHO Technical Report Series948 WHO EXPERT COMMITTEEON SPECIFICATIONS FORPHARMACEUTICAL PREPARATIONSF orty-second reportThe EXPERT COMMITTEE on Specifi cations for PharmaceuticalPreparations works towards clear, independent and practicalstandards and guidelines for the quality assurance of are developed by the COMMITTEE through worldwideconsultation and an international consensus-building following new standards and guidelines were adopted andrecommended for use: the current list of available InternationalChemical Reference Substances and International InfraredReference Spectra; guidelines on the active pharmaceuticalingredient master fi le procedure; the procedure for assessing theacceptability of male latex condoms and that of intrauterine devicesfor purchase by United Nations and other agencies.

2 And a reviewof International Nonproprietary Names for biological andbiotechnological FOR PHARMACEUTICAL PREPARATIONSWHO Technical Report Series 948 ISBN 9789241209489 The World Health Organization was established in 1948 as a specialized agency of the United Nations serving as the directing and coordinating authority for international health matters and public health. One of WHO s constitutional functions is to provide objective and reliable information and advice in the fi eld of human health, a responsibility that it fulfi ls in part through its extensive programme of publications.

3 The Organization seeks through its publications to support national health strategies and address the most pressing public health concerns of populations around the world. To respond to the needs of Member States at all levels of development, WHO publishes practical manuals, handbooks and training material for specifi c categories of health workers; internationally applicable guidelines and standards; reviews and analyses of health policies, programmes and research; and state-of-the-art consensus reports that offer technical advice and recommendations for decision-makers.

4 These books are closely tied to the Organization s priority activities, encompassing disease prevention and control, the development of equitable health systems based on primary health care, and health promotion for individuals and communities. Progress towards better health for all also demands the global dissemination and exchange of information that draws on the knowledge and experience of all WHO s Member countries and the collaboration of world leaders in public health and the biomedical sciences. To ensure the widest possible availability of authoritative information and guidance on health matters, WHO secures the broad international distribution of its publications and encourages their translation and adaptation.

5 By helping to promote and protect health and prevent and control disease throughout the world, WHO s books contribute to achieving the Organization s principal objective the attainment by all people of the highest possible level of WHO Technical Report Series makes available the fi ndings of various international groups of experts that provide WHO with the latest scientifi c and technical advice on a broad range of medical and public health subjects. Members of such EXPERT groups serve without remuneration in their personal capacities rather than as representatives of governments or other bodies; their views do not necessarily refl ect the decisions or the stated policy of annual subscription to this series, comprising about six such reports, costs CHF $ (CHF $ in developing countries).

6 For further information, please contact: WHO Press, World Health Organization, 20 avenue Appia, 1211 Geneva 27, Switzerland (tel. +41 22 791 3264;fax: +41 22 791 4857; e-mail: order on line: ).The International Pharmacopoeia, fourth 1: general notices; monographs for pharmaceutical substances (A O)Volume 2: monographs for pharmaceutical substances (P Z); monographs for dosage forms and radiopharmaceutical preparations; methods of analysis; (1500 pages), also available in CD-ROM format and on lineFirst supplement: general notices; monographs for pharmaceutical substances; monographs for dosage forms; general and specifi c monographs; methods of analysis; International Chemical Reference Substances; International Infrared Reference Spectra.

7 Reagents, test solutions and volumetric solutions, 2008 (in press)Basic tests for drugs: pharmaceutical substances,medicinal plant materials and dosage forms1998 (94 pages)Basic tests for pharmaceutical dosage forms1991 (134 pages)Quality Assurance of Pharmaceuticals: a compendium of guidelines and related materialsVolume 1: 1997 (244 pages)Volume 2: Good manufacturing practices and inspection. 2nd updated edition, 2007 (in press)Also available on: WHO training modules on GMP. A resource and study pack for trainers, 2007 (CD-ROM)WHO EXPERT COMMITTEE on Specifi cations for Pharmaceutical PreparationsForty-fi rst Technical Report Series, No.

8 943, 2007 (156 pages)International Nonproprietary Names (INN) for pharmaceutical substancesCumulative List no. 122007 (available in CD-ROM format only)The use of essential medicinesReport of the WHO EXPERT COMMITTEE (including the 15th Model List of Essential ).WHO Technical Report Series, No. 946, 2007 (163 pages). First WHO Model List ofEssential Medicines for Children ( )WHO EXPERT COMMITTEE on Biological StandardizationFifty-fi fth Technical Report Series, No. 941, 2008 (290 pages) (in press)SELECTED WHO PUBLICATIONS OF RELATED INTERESTF urther information on these and other WHO publications can be obtained from WHO Press,World Health Organization, 1211 Geneva 27, report contains the collective views of an international group of experts.

9 Anddoes not necessarily represent the decisions or the stated policy of the World Health OrganizationWHO Technical Report Series948 WHO EXPERT COMMITTEEON SPECIFICATIONS FORPHARMACEUTICAL PREPARATIONS Forty-second report Geneva 2007 WHO Library Cataloguing-in-Publication DataPublications of the World Health Organization enjoy copyright protection in accordance with the WHO Library Cataloguing-in-Publication DataForty-second report of the WHO EXPERT COMMITTEE on Specifi cations for Pharmaceutical Preparations. (WHO Technical Report Series, No. 948)1.

10 Pharmaceutical preparations - standards. 2. Technology, Pharmaceuticals - standards. 3. Drug industry - legislation. 4. Quality control. I. World Health Organization. II. 978 92 4 120948 9 (NLM classifi cation: QV 771)ISSN 0512-3054 World Health Organization 2008 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: Requests for permission to reproduce or translate WHO publications whether for sale or for noncommercial distribution should be addressed to WHO Press, at the above address (fax: +41 22 791 4806.))