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WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 902 - Thirty-sixth Report
(2002; 219 pages) View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. Quality control - specifications and tests
Open this folder and view contents3. Quality control - reference materials
Open this folder and view contents4. Quality control - pharmaceutical control laboratories
Open this folder and view contents5. Quality assurance - good manufacturing practices
Open this folder and view contents6. Quality assurance - inspection
Open this folder and view contents7. Quality assurance - packaging
Open this folder and view contents8. Quality assurance - general topics
Open this folder and view contents9. Nomenclature and computerized systems
Open this folder and view contents10. Regulatory issues
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 - List of available International Chemical Reference Substances1
View the documentAnnex 2 - List of available International Infrared Reference Spectra
Open this folder and view contentsAnnex 3 - Good practices for national pharmaceutical control laboratories
View the documentAnnex 4 - Considerations for requesting analysis of drug samples1
View the documentAnnex 5 - Basic elements of good manufacturing practices in pharmaceutical production
Open this folder and view contentsAnnex 6 - Good manufacturing practices for sterile pharmaceutical products
Open this folder and view contentsAnnex 7 - Guidelines on pre-approval inspections
Open this folder and view contentsAnnex 8 - Quality systems requirements for national good manufacturing practice inspectorates
Open this folder and view contentsAnnex 9 - Guidelines on packaging for pharmaceutical products
View the documentAnnex 10 - Model certificate of analysis
View the documentAnnex 11 - Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products
View the documentAnnex 12 - Guidelines on the use of International Nonproprietary Names (INNs) for pharmaceutical substances
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 

Acknowledgements

Special acknowledgement was made by the Committee to the following WHO staff members, who assisted in the preparation and proceedings of the meeting: Mrs K. Bremer, Quality Assurance and Safety: Medicines, Essential Drugs and other Medicines; Dr M. Demesmaeker, Quality Assurance and Safety: Medicines, Essential Drugs and other Medicines; Mr P. Graaff, Essential Drugs Programme, WHO Regional Office for the Eastern Mediterranean, Alexandria, Egypt; Dr E. Griffiths, Quality Assurance and Safety: Biologicals, Vaccines and other Biologicals; Dr C.-C. Heuck, Blood Safety and Technology; Dr K. Kimura, Quality Assurance and Safety: Medicines, Essential Drugs and other Medicines; Dr Y. Motarjemi, Protection of the Human Environment; Dr M. Sesay, Policy, Access and Rational Use, Essential Drugs and other Medicines; Dr S. Spinaci, Country Support, Communicable Disease Prevention and Control; Dr G. Szalay, Informatics and Infrastructure Services; Dr M. ten Ham, Drug Safety, Drug Management and Policies; Dr P. Trigg, Communicable Disease Prevention and Control; Mr E. Wondemagegnehu, Quality Assurance and Safety: Medicines, Essential Drugs and other Medicines; Mr T. Yoshida, Quality Assurance and Safety: Medicines, Essential Drugs and other Medicines.

The Committee also acknowledged with thanks the valuable contributions made to its work by the following institutions and individuals: WHO Collaborating Centre for Drug Quality Control, Woden, Australian Capital Territory, Australia; WHO Collaborating Centre for Drug Quality Assurance, Beijing, China; WHO Collaborating Centre for Biopharmaceutical Aspects of Drug Quality Control, Clermont-Ferrand, France; WHO Collaborating Centre for Stability Studies of Drugs, Nantes, France; WHO Collaborating Centre for Drug Information and Quality Control, Budapest, Hungary; WHO Collaborating Centre for Drug Information and Quality Assurance of Essential Drugs, Calcutta, India; WHO Collaborating Centre for Quality Assurance of Essential Drugs, Jakarta, Indonesia; WHO Collaborating Centre for Regulatory Control of Pharmaceuticals, Petaling Jaya, Malaysia; WHO Collaborating Centre for Drug Quality Assurance, Singapore; WHO Collaborating Centre for the Quality Assurance of Drugs, Potchefstroom, South Africa; WHO Collaborating Centre for Chemical Reference Substances, Kungens Kurva, Sweden; WHO Collaborating Centre for International Infrared Reference Spectra, Zurich, Switzerland; WHO Collaborating Centre for Quality Assurance of Essential Drugs, Nonthaburi, Thailand.

Professor R.I. Akubue, University of Nigeria, Nsukka, Nigeria; Mr O. Andriollo, Pharmaciens sans Frontières, Clermont-Ferrand, France; Dr H.E. Bale, Jr, International Federation of Pharmaceutical Manufacturers Associations (IFPMA), Geneva, Switzerland; Professor F. Ballereau, Faculty of Pharmacy, Epidemiology and Public Health, Nantes, France; Dr D. Beck, Basel, Switzerland; Professor R. Boudet-Dalbin, René Descartes University, Paris, France; Mr D.R. Buckley, Therapeutic Goods Administration, Woden, Australian Capital Territory, Australia; Dr Y. Chiu, Office of New Drug Chemistry, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD, USA; Miss M. Cone, IFPMA, Geneva, Switzerland; Mr T. Corquaye, Food and Drugs Board, Accra, Ghana; Mrs E.M. Cortes Montejano, Ministry of Health and Consumer Affairs, Madrid, Spain; Dr R. Dabbah, The United States pharmacopeia, Rockville, MD, USA; Mrs E.F. Damas, Direction de Pharmacie, Ministry of Health, Port-au-Prince, Haiti; Dr G. Détári, National Institute of Pharmacy, Budapest, Hungary; Dr D. Doelcher, West Pharmaceutical Services Deutschland GmbH, Eschweiler, Germany; Mr P. Duneton, Drugs Agency, Saint-Denis, France; Dr R. Freimanis, United States Adopted Names Council, American Medical Association, Chicago, IL, USA; Dr H. Fukuda, Society of Japanese Pharmacopoeia, Tokyo, Japan; Mrs E. Fuller, Geneva, Switzerland; Dr G. Gernez, Villemoisson-sur-Orge, France; Ms E. Gómez, Baxter Laboratories, Cali, Colombia; Dr T. Godschan, Intercantonal Office for the Control of Medicines, Berne, Switzerland; Mr J. Gouws, Medicines Control Council, Cape Town, South Africa; Professor A. Haggag, Alexandria, Egypt; Mr H. Ikäläinen, National Agency for Medicines, Helsinki, Finland; Dr H.J. de Jong, International Regulatory Affairs, Leiden University, Leiden, Netherlands; Dr K. Kawamura, Otsuka Pharmaceutical Co., Tokyo, Japan; Dr M. Keller, Intercantonal Office for the Control of Medicines, Berne, Switzerland; Professor Kil-Soo Kim, Ewha Women’s University, Seoul, Republic of Korea; Mr R. Kuwana, Medicines Control Authority, Harare, Zimbabwe; Mr J. Lanet, Qualassur, Paris, France; Ms K. Lang, Shell Chemicals Ltd, London, England; Dr H. Leblanc, European Chemical Industry Council, Brussels, Belgium; Dr H. Letterman, New Providence, NJ, USA; Mrs V. Li-Frankenstein, UNICEF Supply Division, Copenhagen, Denmark; Dr R. Lindauer, The United States pharmacopeia, Rockville, MD, USA; Professor J. Lipták, National Public Health Service, Budapest, Hungary; Mr J.A. Lisman, Ministry of Health, Welfare and Sport, Rijswijk, Netherlands; Dr K.L. Loening, Topterm, North American Division, Columbus, OH, USA; Dr M.K. Majumdar, Calcutta, India; Mr R.F. Mantik, Bogor, Indonesia; Mrs J. Maritoux, Réseau Médicaments et Développement, Paris, France; Professor L. Martinec, State Institute for the Control of Drugs, Bratislava, Slovakia; Dr N. Miyata, National Institute of Health Sciences, Tokyo, Japan; Mr M.G. Moester, Ministry of Health, Welfare and Sport, Rijswijk, Netherlands; Mrs D. Monk, Australian Pharmaceutical Manufacturers Association, North Sydney, New South Wales, Australia; Mrs Z.J. Montbrun de Reinfeld, National Institute of Hygiene, Caracas, Venezuela; Dr A.B. Moraes da Silva, National Health Institute of Quality Control, Rio de Janeiro, Brazil; Professor R.C. Moreau, Paris, France; Dr M. Negwer, FIZ Chemie, Berlin, Germany; Dr E. Njau, Arusha, United Republic of Tanzania; Professor T.L. Paál, National Institute of Pharmacy, Budapest, Hungary; Dr P.R. Pabrai, Ranbaxy Laboratories Ltd, New Delhi, India; Mrs E. Pelkonen, National Agency for Medicines, Helsinki, Finland; Mr G. Pierce, Division of Emergency and Investigational Operations, Food and Drug Administration, Rockville, MD, USA; Dr S. Raicu, State Institute for Drug Control and Pharmaceutical Research, Bucharest, Romania; Dr M. Raijmakers, Wemos Foundation, Amsterdam, Netherlands; Dr J. Reinstein, World Self-Medication Industry, London, England; Mrs N. Ridolphi, Réseau Médicaments et Développement, Strasbourg, France; Mr N. Sasidharan, World Customs Organization, Brussels, Belgium; Dr K. Satiadarma, Bandung, Indonesia; Mr A. Schijveschuurder, Avrachem AG, Zurich, Switzerland; Dr D. Schnädelbach, Federal Institute for Drugs and Medical Devices, Berlin, Germany; Dr J. Schrank, Interpharma, Basel, Switzerland; Dr M.A. Siewert, Hoechst Marion Roussel, Frankfurt am Main, Germany; Dr E. Spingler-Kloess, Schönenbuch, Switzerland; Mrs L. Stefanini-Oresic, Croatian Institute for Medicines Control, Zagreb, Croatia; Dr S. Sur, Central Laboratory for Quality Control of Medicines, Kiev, Ukraine; Dr R. Szyszkowsky, Latin American Pharmaceutical Industries Association, Buenos Aires, Argentina; Mrs Tan Shook Fong, Ministry of Health, Singapore; Dr R. Tengler, Intercantonal Office for the Control of Medicines, Berne, Switzerland; Dr A. Thépot, Roche, Paris, France; Dr S. Throm, German Association of Research-based Pharmaceutical Companies (VFA) e.V., Bonn, Germany; Mr P. Thummel, Interpharma, Basel, Switzerland; Mr R.B. Trigg, British Pharmacopoeia Commission, London, England; Professor Tu Guoshi, National Institute for the Control of Pharmaceutical and Biological Products, Ministry of Public Health, Beijing, China; Mrs E. Uramis, BioCen National Centre for Bio-Preparations, Havana, Cuba; Dr W. van de Poel, Helvoet S.A., Alken, Belgium; Dr T. van Quy, National Institute of Drug Quality Control, Hanoi, Viet Nam; Mr J.-Y. Videau, Pharmaciens sans Frontières, Clermont-Ferrand, France; Mr P.H. Vree, Ministry of Health, Welfare and Sport, Rijswijk, Netherlands; Mrs M.C. de Vries, Ministry of Health, Welfare and Sport, Rijswijk, Netherlands; Mrs M. Westermark, Apoteket AB, Central Laboratory, Kungens Kurva, Sweden; Professor W. Wieniawski, Polish Pharmacopoeia Commission, Warsaw, Poland; Dr H. Woerder, Bünder Glass GmbH, Bünde, Germany; Dr Woo Soo On, Department of Scientific Services, Institute of Science and Forensic Medicine, Singapore; Mr D.R. Work, North Carolina Board of Pharmacy, Carrboro, NC, USA; Mrs C. Yzer, VFA e.V., Bonn, Germany.

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