WHO Expert Committee on Specifications for Pharmaceutical Preparations Twenty-ninth Report World Health Organization Technical Report Series 704 @ World Health Organization, Geneva 1984ISBN 92 4 120704 3 © World Health Organization 1984 Publications of the World Health Organization enjoy copyright protection in aecondance with the provisions of Protocol? of the Universal Copyright Convention, For rights of reproduction or translation of WHO publications, in past or toto, application should be made tothe Office of Publications, World Health Organization, Geneva, Switzerland. The World Health Organization welcomes such applications. ‘The designations employed and the presentation ofthe material inthis publication do not imply the expression of any opinion whatsoever on the part ofthe Secretariat ofthe World Health Organization concerning the legal status of any country, tertory, city or area or ofits authorities, or concerning the delimitation ofits frontiers or boundaries, ‘The mention of specific eompanies or of certain manufacturers’ products dacs not imply that they are endorsed oF recommended by the World Health Organization in preference to others ofa similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital eters. PRINTED IN SWITZERLAND ea Seer SA 7000CONTENTS Page 1. National laboratories for drug surveillance and control 3 1.1 Proposed model Inborateres 7 2. The Intemational pharmacoposia 9 2.1 Current status of work 9 2.2 Monographs for individual dosage forms 9 23 Quality requirements for pharmaceutical 3185.00 snar en 10 2.4 The use of altemative methods of analssis. 1 25 Pharmacopocial monographs ~ advice to reviewers of drafts 1 2.6 Review of published monographs. : 1 27 International chemical reference substances... 2 28 Infrared reference specira for pharmaceutical substances 1B 29 Stability studies. ~ 5 3. Basic tests sess 5 4. Training programmes in drug analysis. 15 4.1 Group training, 16 42 Individual training. 0 5. Collaboration with nongovernmental organizations. ” 6, Certifcation scheme on the quality of products moving in international commerce : 18 References... 8 Acknowledgements, 9 Annex |. National laboratories for drug quality surveliance and control... 21 Annex 2. Quality requirements for pharmaceutical aids 3 [Annex 3. International chemical reference substances. : o ‘Annex 4, Collaborative study on infrared reference spectra for pharmaceuti al substances 3 ‘Annex 5. Guidanee for those preparing or commenting on monographs for inclusion in The international pharmacopacia 0 Annex 6, Collaboration within the basic test programme so