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WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] 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. The international pharmacopoeia and related issues
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
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 Spectra1
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Open this folder and view contentsAnnex 6. Guidelines for inspection of drug distribution channels
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Open this folder and view contentsAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 

Acknowledgements

The Committee acknowledged with thanks the valuable contribution made to its work by the following members of the WHO Secretariat, WHO Collaborating Centres, institutions, and individuals:

Mr S. Fluss, Health Legislation; Dr E. Griffiths, Biologicals, Division of Drug Management and Policies; Mr S. Holand, Action Programme on Essential Drugs; Dr K. Kimura, Drug Safety, Division of Drug Management and Policies; Mr P.H.L. Lewalle, Computer-Assisted Translation and Terminology; Mr M. Nishizawa, Division of Drug Management and Policies; Dr V. Reggi, Operational Drug Registration, Division of Drug Management and Policies; Mr D. Sato, Division of Drug Management and Policies; Dr J. Schill, Quality Assurance, Division of Drug Management and Policies; Dr T. Sodogandji, Action Programme on Essential Drugs; Dr G. Szalay, Supply Services; Dr M. ten Ham, Drug Safety, Division of Drug Management and Policies; Mr T. Yoshida, Programme on Substance Abuse; Mr E. Wondemagegnehu, Action Programme on Essential Drugs.

WHO Collaborating Centre for Drug Quality Control, Therapeutic Goods Administration Laboratories, Commonwealth Department of Health and Family Services, Woden, Australian Capital Territory, Australia; WHO Collaborating Centre for Drug Quality Assurance, National Institute for the Control of Pharmaceutical and Biological Products, Temple of Heaven, Beijing, China; State Institute for Drug Control, Prague, Czech Republic; WHO Collaborating Centre for Biopharmaceutical Aspects of Drug Quality Control, Biopharmacy Laboratory, Faculty of Pharmacy, University of Clermont-Ferrand, Clermont-Ferrand, France; WHO Collaborating Centre for Stability Studies of Drugs, Regional and University Hospital Centre, Nantes, France; Central Indian Pharmacopoeia Laboratory, Ministry of Health and Welfare, Ghaziabad, India; WHO Collaborating Centre for Drug Information and Quality Assurance of Essential Drugs, Central Drugs Laboratory, Government of India, Calcutta, India; WHO Collaborating Centre for Quality Assurance of Essential Drugs, The National Quality Control Laboratory of Drug and Food, Directorate General of Drug and Food Control, Ministry of Health, Jakarta, Indonesia; Quality Control Department, Mexican Institute of Social Security, Mexico City, Mexico; WHO Collaborating Centre for Drug Quality Control, State Research Institute for the Standardization and Control of Drugs, Ministry of Health, Moscow, Russian Federation; WHO Collaborating Centre for Drug Quality Assurance, Pharmacy Laboratory, Department of Science, Institute of Science and Forensic Medicine, Singapore; WHO Collaborating Centre for Chemical Reference Substances, The National Corporation of Swedish Pharmacies, Central Laboratory, Stockholm, Sweden; WHO Collaborating Centre for International Infrared Reference Spectra, Swiss Federal Institute of Technology, Zurich, Switzerland; WHO Collaborating Centre for Quality Assurance of Essential Drugs, Department of Medical Sciences, Ministry of Public Health, Nonthabury, Thailand.

Professor H.Y. Aboul-Enein, Drug Development Laboratory, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia; Professor J.-M. Aiache, Faculty of Pharmacy, University of Clermont-Ferrand, Clermont-Ferrand, France; Professor R.I. Akubue, Department of Pharmacology and Toxicology, University of Nigeria, Nsukka, Nigeria; Dr S.L. Ali, Association of German Pharmacists' Central Laboratory, Eschborn, Germany; Mrs G. Allen-Young, Pharmaceutical Services, Ministry of Health, Kingston, Jamaica; Dr A. Al Na'amani, Supreme Board of Drugs and Medical Appliances, Ministry of Public Health, Sana'a, Yemen; Dr G. Appelbe, London, England; Dr M. Argenti, National Administration of Medicaments, Food and Medical Technology, Buenos Aires, Argentina; Dr A. Artiges, Council of Europe, European Department for the Quality of Medicines, Strasbourg, France; Professor F. Ballereau, Faculty of Pharmacy, Epidemiology and Public Health, Nantes, France; Mr F.P. Barletta, Division of Standards Development, The United States Pharmacopeial Convention, Inc., Rockville, MD, USA; Dr C. Barnstein, The United States Pharmacopeial Convention, Inc., Rockville, MD, USA; Dr M.C. Becerril-Martinez, United Mexican States Pharmacopoeia, Mexico, Federal District, Mexico; Mr T.M. Berg, Inspectorate for Public Health, Rijswijk, Netherlands; Mr G.H. Besson, Pharmaceutical Inspection Convention, Geneva, Switzerland; Mr R. Bhattacharji, The Narcotics Commissioner of India, Gwalior, India; Professor R. Boudet-Dalbin, Faculty of Pharmaceutical and Biological Sciences of Paris-Luxembourg, Rene Descartes University. Paris, France; Mr D.R. Buckley, GMP Audit and Licensing Section, Conformity Assessment Branch, Therapeutic Goods Administration, Woden, Australian Capital Territory, Australia; Dr J. Cable, Therapeutic Goods Administration Laboratories, Woden, Australian Capital Territory, Australia; Dr D.H. Calam, National Institute for Biological Standards and Control, Potters Bar, Herts., England; Mr G. Catto, World Federation of Proprietary Medicine Manufacturers, London, England; Ms A.M. Cavin, Medical Division, International Committee of the Red Cross, Geneva, Switzerland; Mr P. Chemin, European Community Joint Research Centre, Ispra, Italy: Dr M. Chisale, WHO Regional Office for Africa, Brazzaville, Congo; Mrs V. Christ, Therapeutic Goods Administration, Woden, Australian Capital Territory, Australia; Mrs E.M. Cortes Montejano, Information Service for Drugs, Ministry of Health and Consumer Affairs, Madrid, Spain; Dr C. Coune, Council of Europe, European Department for the Quality of Medicines, Strasbourg, France; Mr M.N. Dauramanzi, Drugs Control Council, Harare, Zimbabwe; Mr J.-F. Dechamp, The European Proprietary Medicines Manufacturers' Association, Brussels, Belgium; Professor J.B. Dressman, Johann Wolfgang Goethe University, Frankfurt (Main), Germany; Miss A. Dulion, National Council of the Pharmacists' Order, Paris, France; Professor P. Eagles, School of Pharmacy, University of the Western Cape, Belleville, South Africa; Dr D.I. Ellsworth, Division of Manufacturing and Product Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD, USA; Dr P. Emafo, Benin City, Nigeria; Mr G. Eskens, International Dispensary Association, Amsterdam, Netherlands; Mr J. Famulare, Case Management and Guidance Branch, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD, USA; Dr F.Y. Fazli, Social Education and Social Welfare, Ministry of Health, Islamabad, Pakistan; Dr R. Freimanis, Office of Drug Nomenclature, United States Adopted Names Council, American Medical Association, Chicago, IL, USA; Dr H. Fukuda, Society of Japanese Pharmacopoeia, Tokyo, Japan; Professor D. Ganderton, Cheriton Bishop, Devon, England: Dr L.T. Grady, The United States Pharmacopeial Convention, Inc., Rockville, MD, USA: Ms S. Greve, The National Board of Health, Medicines Division, Bronshøj, Denmark: Dr W. Grosse, Corporate Quality Assurance, Eli Lilly and Company, Indianapolis, IN, USA; Professor U. Gunder-Remy, University of Göttingen, Göttingen, Germany; Dr S. Haghighi, Food and Drug Quality Control Laboratories, Ministry of Health, Teheran, Islamic Republic of Iran; Dr A.I. Hag Omer, Drug Quality Control, National Chemical Laboratories, Federal Ministry of Health, Khartoum, Sudan; Mrs M. Hietava, Department of General Affairs, National Agency for Medicines, Helsinki, Finland; Dr H. Hoffmann, Kelkheim im Taunus, Germany; Mr H. Hofstetter, Intercantonal Office for the Control of Medicines, Berne, Switzerland; Mr R.K. Howard, Therapeutic Goods Administration Laboratories, Woden, Australian Capital Territory, Australia; Mr H. Ikäläinen, Department of General Affairs, National Agency for Medicines, Helsinki, Finland; Mrs M. Ikeda, Ministry of Health and Welfare, Japan; Dr D. Jayasuriya, United Nations International Drug Control Programme, New Delhi, India; Professor Jin Shaohong, National Institute for the Control of Pharmaceutical and Biological Products, Ministry of Public Health, Beijing, China: Mr V. Johanson, Nutritional Foods Association of Australia, Deakin, Australian Capital Territory, Australia; Dr E. Keller, Quality Assurance Services, Novartis, Basel, Switzerland; Dr I.O. Kibwage, Drug Analysis and Research Unit, Department of Pharmacy, University of Nairobi, Nairobi, Kenya; Dr D. Kiima, Department of Mental Health, Ministry of Health, Nairobi, Kenya; Mr R.H. King, Division of Standards Development, Technical Services, The United States Pharmacopeial Convention, Inc., Rockville, MD, USA; Dr Q.L. Kintanar, Department of Health, Bureau of Food and Drugs, Muntinlupa, Philippines; Dr E. Kkolos, Pharmaceutical Services, Ministry of Health, Nicosia, Cyprus; Dr W. Kleinert, The Federal Institute for Drugs and Medical Devices, Federal Opium Agency, Berlin, Germany; Dr J. Krämer, Association of German Pharmacists' Central Laboratory, Eschborn, Germany; Professor Y. Krylov, State Pharmacopoeia Committee of the Russian Federation, Ministry of Health, Moscow, Russian Federation; Mr J. Lanet, Qualassur, Paris, France; Mrs N.T. Lanuza, Regulation Division, Department of Health, Bureau of Food and Drugs, Metro Manila, Philippines; Mr P. Lefèvre, Drug Agency, Saint-Denis, France; Dr R. Lindauer, Drug Research and Testing Laboratory, The United States Pharmacopeial Convention, Inc., Rockville, MD, USA; Mr M. Lindroos, Ministry of Social Affairs and Health, Helsinki, Finland; Dr K.L. Loening, Topterm, North American Division, Columbus, OH, USA; Mrs M.-H. Loulergue, Laboratories and Control Directorate, Drug Agency, Saint-Denis, France; Dr R.J.J.C. Lousberg, Inspectorate for Health Care, Rijswijk, Netherlands; Professor B.I. Lyubimov, Research Institute of Pharmacology, Russian Academy of Medical Sciences, Moscow, Russian Federation; Mr E. Magnusson, Pharmaceuticals, Ministry of Health, Reykjavik, Iceland; Dr S. Marrer, Quality Assurance, F. Hoffmann-La Roche Ltd, Basel, Switzerland; Associate Professor L. Martinec, State Institute for the Control of Drugs, Bratislava, Slovakia; Dr I.N. Matondo, Regional Drug Control Laboratory, Harare, Zimbabwe; Mr S. Mattmüller, Hewlett-Packard GmbH, Waldbronn, Germany; Dr G.L. Mattok, Pharmaceutical Chemistry Division, Bureau of Drug Research, Health Protection Branch, Ottawa, Ontario, Canada; Mr I. Mboninyibuka, National Pharmaceutical Office, Bujumbura, Burundi; Mrs N. McClay, Regulatory Affairs and External Liaison, European Generic Medicines Association, Brussels, Belgium; Professor K.K. Midha, University of Saskatchewan, Saskatoon, Canada; Dr N. Miyata, Division of Organic Chemistry, National Institute of Health Sciences, Tokyo, Japan; Dr S. Mizuno, Department of Bioactive Molecules, National Institute of Health, Tokyo, Japan; Professor H. Möller, Hoechst AG, Hoechst Marion Roussel, Frankfurt (Main), Germany; Mrs D. Monk, Scientific and Technical Affairs, Australian Pharmaceutical Manufacturers Association, North Sydney, Australia; Professor R.C. Moreau, Paris, France; Mr F. Mounis, International Technical Cooperation, Médecins sans Frontières, Brussels, Belgium; Mrs N. Naim, Pharmaceutical Services, Ministry of Health, Jalan University, Petaling Jaya, Malaysia; Dr M. Negwer, Berlin, Germany; Dr J.D. Nicholson, Medicines Testing Laboratory, Department of Pharmaceutical Sciences, Royal Pharmaceutical Society of Great Britain, Edinburgh, Scotland; Dr E. Njau, Arusha, United Republic of Tanzania; Professor A.A. Olaniyi, Department of Pharmaceutical Chemistry, University of Ibadan, Ibadan, Nigeria; Dr C. Ondari, Department of Health Sciences, University of Nairobi, Nairobi, Kenya; Dr P.R. Pabrai, Ranbaxy Laboratories Ltd., New Delhi, India; Dr R. Patnaik, Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD, USA; Dr J. Portych, Czech Pharmacopoeia Commission, State Institute for Drug Control, Ministry of Health, Prague, Czech Republic; Mrs P. Rafidison, International Pharmaceutical Excipients Council-Europe, Dow Corning France SA, Sophia Antipolis, France; Professor M. Rafiee-Tehrani, College of Pharmacy, University of Medical Sciences, Tehran, Islamic Republic of Iran; Professor L. Rägo, State Agency of Medicines, Tarfu, Estonia; Professor J. Richter, Berlin, Germany; Mr P. Romagnoli, European Generic Medicines Association, Aschimfarma, Milan, Italy; Dr A. Saddem, National Drug Control Laboratory, Ministry of Public Health, Tunis, Tunisia; Dr V. Saliasi, Pharmaceutical Services, Ministry of Health, Tirana, Albania; Dr K. Satiadarma, Bandung, Indonesia; Mr H. Schaepe, United Nations International Drug Control Programme, Narcotics Control Board, Vienna, Austria; Mrs S. Schlabitz, Medicines Control Council, Windhoek, Namibia; Professor J. Schlebusch, Department of National Health and Population Development, Pretoria, South Africa; Dr P.J. Schorn, Council of Europe, European Department for the Quality of Medicines, Strasbourg, France; Dr D. Schwarzenbach, Quality Assurance Services, Novartis, Basel, Switzerland; Dr A. Sheak, Department of Drug Administration, Ministry of Health, Kathmandu, Nepal; Dr M.A. Siewert, Quality Control/Quality Assurance, Hoechst AG, Hoechst Marion Roussel, Frankfurt (Main), Germany; Ms K. Sinivuo, National Medicines Control Laboratory, Helsinki, Finland; Professor C.J.P. Siregar, Bandung, Indonesia; Dr D.S. Skinner, Nonprescription Drug Manufacturers' Association of Canada, Ottawa, Ontario, Canada; Dr M. Smíd, State Institute for Drug Control, Prague, Czech Republic; Ms M. Soaki, Ministry of Health, Nuku'alofa, Tonga; Dr E. Spindler-Kloess, Schönenbuch, Switzerland; Dr V. Srdanovic, United Nations Children's Fund, Copenhagen, Denmark; Mrs L. Stefanini-Oresic, Croatian Institute for Medicines Control, Zagreb, Croatia; Dr D. Steinbach, Bad Homburg, Germany; Dr A. Sulistiowati, National Quality Control Laboratory of Drug and Food, Ministry of Health, Jakarta, Indonesia; Dr S.K. Talwar, Central Indian Pharmacopoeia Laboratory, Ministry of Health and Family Welfare, Ghaziabad, India; Professor R. Taylor, School of Pharmacy, The Gordon University, Aberdeen, Scotland; Dr K.-H, Teichmann, Hoechst AG, Hoechst Marion Roussel, Frankfurt (Main), Germany; Miss A. Thépot, Paris, France; Mr J.-F. Thony, United Nations International Drug Control Programme, Vienna, Austria; Mr C.A.C. Tomé dos Reis, Infarmed, National Institute of Pharmacy and Drugs, Lisbon, Portugal; Professor A. Toumi, Pharmacy and Drugs Directorate, Ministry of Public Health, Tunis, Tunisia: Dr P.G. Treagust, Reference Materials Group, SmithKline Beecham Pharmaceuticals, Worthing, West Sussex, England; Mr R.B. Trigg, British Pharmacopoeia Commission, London, England; Mr S. Tsuda, International Affairs Division, Ministry of Health and Welfare, Tokyo, Japan; Mr M. Tsukano, Ministry of Health, Tokyo, Japan: Professor Tu Guoshi, National Institute for the Control of Pharmaceutical and Biological Products, Ministry of Public Health, Beijing, China; Mr J.L. Turner, Inspection and Enforcement Division, Medicines Control Agency, London, England; Dr V. de Urioste, National Department of Drug, Pharmacy and Laboratories. Ministry of Health, La Paz, Bolivia; Mr S. Uzu, Planning Division, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, Tokyo, Japan; Dr T. Van Quy, National Institute of Drug Quality Control, Hanoi, Viet Nam; Mr M. Venkateswarlu, Central Government Health Scheme Dispensary Building, Mumbai, India; Dr M. Vernengo, School of Health Sciences, Belgrano University, Buenos Aires, Argentina; Dr J.P. Vora, Karnataka Antibiotics and Pharmaceuticals Ltd, Bangalore, India; Dr I. Vukusic, Podravka-Food, Pharmaceuticals and Cosmetics Industries, Zagreb, Croatia; Dr R. Walters, Cardio-Renal Drug Products, Food and Drug Administration, Rockville, MD, USA; Professor W. Wieniawski, Polish Pharmacopoeia Commission, Warsaw, Poland; Dr C. Wongpinairat, Division of Drug Analysis, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand; Dr Woo Soo On, Department of Scientific Services, Institute of Science and Forensic Medicine, Singapore.

 

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