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WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report
(2003; 148 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. General policy
Open this folder and view contents3. Quality control - specifications and tests
View the document4. Quality control - international reference materials
Open this folder and view contents5. Quality control - national laboratories
Open this folder and view contents6. Quality assurance - good manufacturing practices
Open this folder and view contents7. Quality assurance - inspection
Open this folder and view contents8. Quality assurance - distribution and trade-related
Open this folder and view contents9. Quality assurance - risk analysis
Open this folder and view contents10. Quality assurance - drug supply
Open this folder and view contents11. Quality assurance - storage
View the document12. International Nonproprietary Names (INNs) programme
Open this folder and view contents13. Miscellaneous
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 Recommendations on risk of transmitting animal spongiform encephalopathy agents via medicinal products
View the documentAnnex 2 The International Pharmacopoeia: revised concepts and future perspectives
Open this folder and view contentsAnnex 3 Guidelines on Good Manufacturing Practices for radiopharmaceutical products
Open this folder and view contentsAnnex 4 Good Manufacturing Practices for pharmaceutical products: main principles
View the documentAnnex 5 Model certificate of Good Manufacturing Practices
View the documentAnnex 6 Guidance on Good Manufacturing Practices (GMP): inspection report
View the documentAnnex 7 Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals
Open this folder and view contentsAnnex 8 Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies
Open this folder and view contentsAnnex 9 Guide to good storage practices for pharmaceuticals1
View the documentBack cover
 

Acknowledgements

Special acknowledgement was made by the Committee to Dr S. Kopp and Dr P. Vanbel, Quality Assurance and Safety: Medicines, Essential Drugs and Medicines Policy, WHO, Geneva, Switzerland, who were both instrumental in the preparation and proceedings of the meeting.

The Committee also acknowledged with thanks the valuable contributions made to its work by the following institutions and persons:

WHO Collaborating Centre for Drug Quality Control, Therapeutic Goods Administration Laboratories, 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; WHO Collaborating Centre for Biopharmaceutical Aspects of Drug Quality Control, Biopharmaceutical Laboratory, University of Clermont-Ferrand, Clermont-Ferrand, France; WHO Collaborating Centre for Drug Information and Quality Assurance, National Institute of Pharmacy, Budapest, Hungary; WHO Collaborating Centre for Quality Assurance of Essential Drugs, Central Drugs Laboratory, 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; WHO Collaborating Centre for Regulatory Control of Pharmaceuticals, National Pharmaceutical Control Bureau, Jalan University, Ministry of Health, Petaling Jaya, Malaysia; FIP Sections: Industrial Pharmacy, Laboratories and Medicines Control Services, Military Pharmacy and Community Pharmacy, Netherlands; WHO Collaborating Centre for Drug Quality Assurance, Pharmaceutical Laboratory, Centre for Analytical Science, Health Sciences Authority, Singapore; WHO Collaborating Centre for Quality Assurance of Drugs, Potchefstroom University for Christian Higher Education, Potchefstroom, South Africa; WHO Collaborating Centre for Chemical Reference Substances, The National Corporation of Swedish Pharmacies, Central Laboratory, Kungens Kurva, 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, Nonthaburi, Thailand.

Ms N. Abbasi and Ms Z. Abbasi, Royal Danish School of Pharmacy, Department of Pharmaceutics, Copenhagen, Denmark; Dr Z. Abeid, Pharmaceutical Department, Ministry of Health and Population, Cairo, Egypt; Professor I. Addae-Mensah, University of Ghana, Legon/Accra, Ghana; Professor J.-M. Aiache, WHO Collaborating Centre for Biopharmaceutical Aspects of Drug Quality Control, University of Clermont-Ferrand, Clermont-Ferrand, France; Professor A. Agoumi, Director, Medicines and Pharmacy, Ministry of Health, Rabat-Institute, Rabat, Morocco; Mrs S. Ahmed Jaffar, Directorate General of Pharmaceutical Affairs and Drugs Control, Ministry of Health, Muscat, Oman; Dr W. Akarawut, Department of Medical Science, Nonthaburi, Thailand; Professor P.I. Akubue, Department of Pharmacology and Toxicology, University of Nigeria, Nsukka, Nigeria; Mr A.H. Al-Abdullah, Ministry of Public Health, Doha, Qatar; Dr A. Al Na’amani, Supreme Board of Drugs and Medical Appliances, Ministry of Public Health, Sana’a, Yemen; Dr M.I. Al-Hail, Director, Pharmacy and Drug Control Department, Ministry of Public Health, Doha, Qatar; Dr S.L. Ali, Deputy Director, Zentrallaboratorium Deutscher Apotheker, Eschborn, Germany; Dr R. Allman, Medicines and Medical Devices Safety Authority, Business Unit of the Ministry of Health, Auckland, New Zealand; Dr O. Andriollo, Medicopharmaceutical Humanitarian Centre, Clermont-Ferrand, France; Dr M. Argenti, National Administration of Medicaments, Food and Medical Technology, Buenos Aires, Argentina; Dr A. Artiges, European Directorate for the Quality of Medicines, Council of Europe, Strasbourg, France; Ms A.C. Baron, CEFIC/APIC, CEFIC Sector Group, Brussels, Belgium; Dr C. Barnstein, The United States Pharmacopeial Convention Inc., Drug Information Division, Rockville, MD, USA; Dr P.M. Bazerque, Secretariat for Policies and Health Regulation, Ministry of Health, Argentina (Chairperson); Professor Y. Bensouda, Mohammed V University, Laboratory of Galenical Pharmacy, Rabat, Morocco; Dr D. Bentley, Senior Medicines Inspector, Medicines Control Agency, York, England; Mr G.H. Besson, Pharmaceutical Inspection Convention, Geneva, Switzerland; Dr S.M. Binti Jaafar, Acting Director, Pharmaceutical Services, Ministry of Health, Bandar Seri Begawan, Brunei Darussalam; Professor H. Blume, Oberursel, Germany; Dr D.L. Boring, Food and Drug Administration, Rockville, MD, USA; Dr L. Borka, Oslo, Norway; Mr B. Botwe, Food and Drugs Board, Accra Ghana; Mr G. Bourdeau, ReMed Association, Mereville, France; Dr R. Boudet-Dalbin, Faculty of Pharmaceutical and Biological Sciences of Paris-Luxembourg, René Descartes University, Paris, France; Ms K. Bremer, Norwegian Medicines Control Agency, Oslo, Norway; Dr P.O. Bremer, Isopharma AS, Kjeller, Norway; Mr P. Castle, European Directorate for the Quality of Medicines, Council of Europe, Strasbourg, France; Mr G. Catto, World Federation of Proprietary Medicine Manufacturers, London, England; Mrs Chen Yan, GMP Inspector, Center for Certification, State Drug Administration, Beijing, China; Dr P. Christen, Analytical Pharmaceutical Chemistry Laboratory, University of Geneva, Geneva, Switzerland; Dr W.-K. Chui, Department of Pharmacy, National University of Singapore, Singapore; Miss M. Cone, PJB Publications Ltd, Richmond, UK; Dr J. Cordoba, Faculty of Pharmacy, University of Costa Rica, San José, Costa Rica; Ms E.M. Cortes Montejano, Ministry of Health and Consumer Affairs, Information for Drugs, Madrid, Spain; Ms F. Dansereau, Health Products and Food Branch Inspectorate, National Coordination Center, Ottawa, Ontario, Canada; Mr M.N. Dauramanzi, Medicines Control Authority of Zimbabwe, Harare, Zimbabwe; Dr M. Demesmaeker, Bassins, Switzerland; Mrs L. Déry, International Policy Division, Bureau of Policy and Coordination, Therapeutic Products Programme, Ottawa, Canada; Mr M. Dixon, Corporate Quality Assurance, Eli Lilly and Company, Windlesham, UK; Ms L. Djuki´c, Institute of Pharmacy of Serbia, Authorised Institution for Medicines Testing and Control, Belgrade, Yugoslavia; Professor E. Doelker, University of Geneva, Geneva, Switzerland; Dr D.I. Ellsworth, Division of Manufacturing and Product Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD, USA; Dr T. Eriksen, Sudaththa Liyanaarachchi, Avissawella, Sri Lanka; Mr S. Fairchild, European Agency for Evaluation of Medicinal Products, London, England; Dr C.J. Fallais, University of Liège and the Free University of Brussels, Brussels, Belgium; Dr A. Farina, Higher Institute of Health, Ministry of Health, Rome, Italy; Dr E. Fefer, International Affairs, US Pharmacopoeia, Rockville, MD, USA; Mrs S. Fuerst, The USAN Council Program, AMA, Chicago, IL, USA; Dr H. Fukuda, Society of Japanese Pharmacopoeia, Tokyo, Japan; Ms D. Gal, International Pharmaceutical Federation, The Hague; Netherlands; Mr S. Ghani, Division of Pharmaceutical Quality, Therapeutic Products Programme, Ottawa, Ontario, Canada; Ms E. Gomez Munoz, Quality Assurance and Regulatory Affairs, Baxter Laboratories, Cali, Colombia; Dr R. Gooch, Representative of the International Pharmaceutical Federation, Netherlands; Dr. T. Gosdschan, Intercantonal Office for the Control of Medicines, Division of Inspections, Bern, Switzerland; Mr P. Graaff, WHO Regional Office for the Eastern Mediterranean, Alexandria, Egypt; Dr O. Gross, Pharmaceutical Starting Materials Unit, Directorate of Inspection of Establishments, French Agency for Health Safety of Health Products, Saint-Denis, France; Professor A.A. Haggag, Department of Biochemistry, College of Pharmacy, University of Tanta, Tanta, Egypt; Dr S. Haghighi, Pharmaceutical and Microbiology Department, Institute Pasteur of Iran, Teheran, the Islamic Republic of Iran; Ms N. Haji Naim, Pharmaceutical Services, Ministry of Health, Jalan University, Petaling Jaya, Malaysia; Dr N.G. Hartman, The Ottawa Hospital, Division of Nuclear Medicine, Ottawa, Ontario, Canada; Dr P. Helboe, Pharmaceutical Affairs, Danish Medicines Agency, Brønshøj, Denmark; Dr E. Henriksen, Division of Manufacturing and Product Quality, Office of Compliance, FDA, Rockville, MD, USA; Mr H. Hofstetter, Intercantonal Office for the Control of Medicines, Bern, Switzerland; Professor J. Hoogmartens, Katholieke Universiteit Leuvery, Leuven, Belgium; Dr J. Hoose, Agency for Work, Health and Social Office for Health, Health Department, Hamburg, Germany; Dr H. Ibrahim, DebioPharm SA, Lausanne, Switzerland; Professor R. Jachowicz, Department of Pharmaceutical Technology and Biopharmaceutics, Jagiellonian University, Cracow, Poland; Mr M. Jahnsson, Technical Coordination Unit - Inspections, The European Agency for the Evaluation of Medicinal Products, London, England; Professor Jin Shaohong, National Institute for the Control of Pharmaceutical and Biological Products, Ministry of Public Health, Beijing, China; Mrs G. Jiragobchaipong, Division of Drug Analysis, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand; Dr A. Kakwemeire, National Drug Quality Control Laboratory, Uganda National Drug Authority, Kampala, Uganda; Dr K. Kawamura, Japan PDA, Tokyo, Japan; Mr M. Keller, Intercantonal Office for the Control of Medicines, Division of Inspections, Bern, Switzerland; Dr S. Kennedy, Technical Co-ordination, Inspection Sector, European Agency for the Evaluation of Medicinal Products, London, England; Professor S. Khomvili, Hoechst Marion Roussel Industry, Thailand; Ms K. Kikule, National Drug Authority, Kampala, Uganda; Dr Q.L. Kintanar, Bureau of Food and Drugs, Ministry of Health, Muntinlupa, Philippines; Dr P. Kokkinou, Pharmaceutical Services, Ministry of Health, Lefkosia, Cyprus; Professor M.A. Koupparis, Laboratory of Analytical Chemistry, Department of Chemistry, University of Athens, Athens, Greece; Dr R. Krause, International Federation of Pharmaceutical Manufacturers Associations, Geneva, Switzerland; Professor H.G. Kristensen, Royal Danish School of Pharmacy, Department of Pharmaceutics, Copenhagen, Denmark; Dr P.B Kulkarni, Technical Services Division, Bhabha Atomic Research Centre, Mumbai, India; Mr R. Kuwana, Medicines Control Authority, Harare, Zimbabwe; Mr J. Lanet, Qualassur, Paris, France; Dr T. Lapnet Moustapha, National Drug Quality Control and Valuation Laboratory, Yaoundé, Cameroon; Mr P. Lefévre, Medicines Agency, Saint Denis, France; Ms E. Leinonen, National Agency for Medicines, Helsinki, Finland; Dr A.C. Lezama, Health Protection Groups, Ministry of Health, Bogotá, Colombia; Dr J. Linn, National Pharmaceutical Administration, Ministry of Health, Merah, Singapore; Professor J. Lipták, Ministry of Health, Budapest, Hungary; Mr J. Lisman, A-CBG, The Hague, Netherlands; Dr M.K. Majumdar, Damason Consultancy Services, Jadavpur, India; Professor A.P. Masurek, Drug Institute, Warsaw, Poland; Dr A. Mechkovski, Moscow, Russian Federation; Ms M. Miljkovic, Institute of Pharmacy of Serbia, Belgrade, Yugoslavia; Dr J.H. McB. Miller, European Directorate for the Quality of Medicines, Council of Europe, Strasbourg, France; Professor J. Mircheva, AESGP (Representative of WSMI), Brussels, Belgium; Dr A. Mitrevej, Vice-President for Academic Affairs, Pharmaceutical Association of Thailand, Bangkok, Thailand; Mr M. Moester, Inspectorate for Health Care, Rijswijk, Netherlands; Professor H. Möller, Central Laboratory of German Pharmacists, Eschborn, Germany; Mrs A.B. Moraes da Silva, National School of Public Health (FIOCRUZ), Coordination of Technical Cooperation, Rio de Janeiro, Brazil; Dr O. Morin, Regulatory and Scientific Affairs, International Federation of Pharmaceutical Manufacturers Associations, Geneva, Switzerland; Dr G. Munro, Head of Inspection and Enforcement, Medicines Control Agency, London, England; Dr S. Myat Tun, Department of Health, Food and Drug Administration, Ministry of Health, Yangon, Myanmar; Dr Myint-Sein, Ministry of Industry, Myanmar Pharmaceutical Industries, Yangon, Myanmar; Dr D.V.S. Narasimhan, Division of Physical and Chemical Sciences, International Atomic Energy Agency, Vienna, Austria; Dr R. Nash, Mahwah, NY, USA; Dr E. Njau, Arusha, United Republic of Tanzania; Professor A.A. Olaniyi, Department of Pharmaceutical Chemistry, University of Ibadan, College of Medicine, Ibadan, Nigeria; Dr C. Ondari, Department of Health Sciences, University of Nairobi, Nairobi, Kenya; Professor T. Paál, National Institute of Pharmacy, WHO Collaborating Centre for Drug Information and Quality Assurance, Budapest, Hungary; Dr P.R. Pabrai, Sarita Vihar, New Delhi, India; Dr M.I. Pacecca, Training and Research Department, National Administration of Medicines, Foods and Medical Technology (ANMAT), Ministry of Health, Buenos Aires, Argentina; Dr C.O. Pannenborg, Sector Leader for Health, Nutrition and Population, Africa Region, The World Bank, Washington, DC, USA; Dr K.B. Park, Radioisotope Department, Korea Atomic Energy Institute, Taejon, Republic of Korea; Dr I.J. Petersen, Department of Pharmaceutical Affairs, Ministry of Health and Social Security, Reykjavík, Iceland; Dr L.E. Pino Arango, Ministry of Health, Bogotá, Colombia; Dr J. Pogány, Consivers Consulting and Translation Group, Budapest, Hungary; Dr W. Pohler, Pharmaceutical Sciences, Aventis Pharma AG, Frankfurt am Main, Germany; Miss A. Poompanich, Division of Drug Analysis, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand; Ms M.-L. Rabouhans, Chiswick, England; Dr P. Rafidison, IPEC-Europe, GMP/GDP Committee, Global Life Sciences, Dow Corning, Opio, France; Dr N. Ramamoorthy, Board of Radiation and Isotope Technology, Department of Atomic Energy, Mumbai, India; Dr J. Reden, Scientific and Regulatory Affairs, European Federation of Pharmaceutical Industries and Associations, Brussels, Belgium; Mr G. Requin, Ministry of Health and Quality of Life, Port Louis, Mauritius; Mr P. Romagnoli, European Generic Medicines Association, Aschimfarma, Milan, Italy; Dr B. Sabri, Health Systems and Community Development, Office of WHO Representative, Riyadh, Saudi Arabia; M.S.C. Sanchez Gonzalez, Centre for State Control of Drug Quality, Havana, Cuba; Dr J.-M. Sapin, Head, Inspection Unit, AFSSA, Lyon, France; Dr K. Satiadarma, Bandung, Indonesia; Dr M. Schaffhauser, Intercantonal Office for the Control of Medicines, Control of Manufacture, Bern, Switzerland; Ms M. Schmid, Saconnex d’Arvelt, Switzerland; Professor J. Schlebusch, Medicines Control Council Department of Health, Pretoria, South Africa; Dr J. Schrank, Scientific, Technical and Regulatory Affairs, Interpharma, Basel, Switzerland; Mr G. Schwartzman, Sarasota, FL, USA; Dr G.V. Shashkova, Ministry of Health, Moscow, Russian Federation; Dr A. Sheak, Department of Drug Administration, Ministry of Health, Kathmandu, Nepal; Dr M. Sheikh, A/DHS, Syrian Arab Republic; Dr E.B. Sheinin, Information and Standards Development, United States Pharmacopeia, Rockville, MD, USA; Dr M. Siewert, Environmental Health and Safety, Aventis Pharma AG, Frankfurt am Main, Germany; Dr S. Singh, Department of Pharmaceutical Analysis, Nagar, Punjab, India; Ms K. Sinivuo, National Agency for Medicines, Helsinki, Finland; Dr A.E. Smedstad, Norwegian Association of Proprietor Pharmacists, Oslo, Norway; Dr M. Smid, State Institute for Drug Control, Prague, Czech Republic; Dr R.J. Smith, Therapeutic Goods Administration Laboratories, Woden, Australian Capital Territory, Australia; Ms J. Solano Galvis, Ministry of Health, Directorate-General for Public Health, Bogotá, Colombia; Dr J.-M. Spieser, European Directorate for the Quality of Medicine, Council of Europe Strasbourg, France; Mrs L. Stefanini-Oresíc, Croatian Institute for Medicine Control, Zagreb, Croatia; Dr A. Sulistiowati, Division of Therapeutic Products and Hazardous Substances, National Quality Control Laboratory of Drugs and Food, Jakarta, Indonesia; Dr S. Sur, State Inspection for Quality Control of Medicines, Council of Europe Ministry of Health, Kiev, Ukraine; Mr M. Suzuki, Fuji Public Health Center, Fuji-shi, Japan; Mr P. Svarrer Jakobsen, UNICEF, Freeport, Copenhagen, Denmark; Ms Y. Tayler, The World Bank, Washington, DC, USA; Dr M. ten Ham, Department of Pharmaceutical Affairs, Ministry of Public Health, Welfare and Sport, The Hague, Netherlands; Dr S. Throm, Research and Development, Association of Research Drug Manufacturers, Berlin, Germany; Dr W.D. Torres, Department of Health, Bureau of Food and Drugs, Alabang, Muntinlupa, Philippines; Professor A. Toumi, Directorate of Pharmacy and Medicines, Ministry of Public Health, Bab Sadoun, Tunisia; Mr R. Tribe, Conformity Assessment Branch, Therapeutic Goods Administration, Woden, Australian Capital Territory, Australia; Mr R.B. Trigg, British Pharmacopoeia Commission, London, England; Professor Tu Guoshi, Division of Pharmaceutical Chemistry, National Institute for the Control of Pharmaceutical and Biological Products, Ministry of Public Health, Beijing, China; Dr N. Turner, Gloxa Smith Kline, Ware, England; Ms E. Uramis Diaz, National Centre for Biological Products, Havana, Cuba; Mr S. Uzu, Planning Division, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, Tokyo, Japan; Mr P. van der Hoeven, Active Pharmaceutical Ingredients Committee, European Chemical Industry Council, Brussels, Belgium; Dr J. van Oudtshoorn-Eckard, Monument Park, South Africa; Dr S. Vasanavathana, Office of Food and Drug Administration, Ministry of Public Health, Nonthaburi, Thailand; Ms M. Veek, Office of International Program, FDA, Rockville, MD, USA; Dr M. Venkateswarlu, Central Drugs Standard Control Organization, Bombay, India; Dr H. Vera Ruiz, International Atomic Energy Agency, Vienna, Austria; Dr J.-Y. Videau, Humanitarian Medical and Pharmaceutical Centre, Clermont-Ferrand, France; Mr P.H. Vree, The Inspectorate of Health Care, Maasdam, Netherlands; Mr Wang Ping, The Chinese Pharmacopoeia Commission, Ministry of Health, Beijing, China; Dr S. Wibulpolprasert, Bureau of Health Policy and Planning, Ministry of Public Health, Nonthaburi, Thailand; Dr W. Wieniawski, Polish Pharmacopoeia Commission, Warsaw, Poland; Dr R.L. Williams, United States Pharmacopeia, Rockville, MD, USA; Dr Woo Soo On, WHO Collaborating Centre for Drug Quality Assurance, Health Sciences Authority, Singapore; Mr Yang Lahu, National Research Centre for the Standardization of Pharmaceutical and Biological Products, Ministry of Public Health, Beijing, China; Professor Yang Zhong-Yuan, Guangzhou Municipal Institute for Drug Control, Guangzhou, China; Dr Zhou Haijun, National Institute for the Control of Pharmaceutical and Biological Products, WHO Collaborating Centre for Drug Quality Assurance, Beijing, China; Ms A. Zima, State Institute for Drug Control, Prague, Czech Republic.

 

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