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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
 

WHO Expert Committee on Specifications for Pharmaceutical Preparations

Geneva, 22 - 26 October 2001

Members*

* Unable to attend: Mrs A.B. Moraes da Silva, National School of Public Health (FIOCRUZ), Coordination of Technical Cooperation, Rio de Janeiro, Brazil.


Professor I. Addae-Mensah, Vice-Chancellor, University of Ghana, Accra, Ghana (Chairperson)

Ms K. Bremer, Director, Medicines, Norwegian Control Authority, Oslo, Norway (Co-Chairperson)

Professor A.A. Haggag, Department of Biochemistry, College of Pharmacy, University of Tanta, Tanta, Egypt

Professor Jin Shaohong, Deputy Director, National Institute for the Control of Pharmaceutical and Biological Products, Beijing, China

Ms A. Poompanich, Senior Technical Advisor (Efficacy of Medicine), Department of Medical Sciences, Ministry of Public Health, WHO Collaborating Centre for Drug Quality Assurance, Nonthaburi, Thailand

Mr R.W. Tribe, Chief GMP Auditor, Conformity Assessment Branch, Therapeutic Goods Administration, Woden, ACT, Australia (Rapporteur)

Representatives of other organizations

Unable to attend: European Chemical Industry Council (CEFIC), Brussels, Belgium; International Pharmaceutical Federation (FIP), The Hague, Netherlands; Pharmaceutical Inspection Convention (PIC), Geneva, Switzerland; United Nations Industrial Development Organization (UNIDO), Vienna, Austria; The World Bank, Washington, DC, USA; World Trade Organization (WTO), Geneva, Switzerland.


Council of Europe

Dr J.H.McB. Miller, Head of Division III (Laboratory), European Directorate for the Quality of Medicines, Council of Europe, Strasbourg, France

International Atomic Energy Agency (IAEA)

Dr H.V. Ruiz, Head, Industrial Applications and Chemistry Section, Vienna, Austria

International Federation of Pharmaceutical Manufacturers Associations (IFPMA)

Dr O. Morin, Director, Regulatory and Scientific Affairs, IFPMA, Geneva, Switzerland

International Pharmaceutical Excipients Council (IPEC)

Dr P. Rafidison, Chairperson, GMP/GDP Committee, IPEC Europe, Opio, France

United Nations Children’s Fund (UNICEF)

Ms Thuy Huong Ha, Technical Services Centre, UNICEF Supply Division, Copenhagen, Denmark

World Self-Medication Industry (WSMI)

Dr J.A. Reinstein, Director-General, WSMI, London, England

Secretariat*

* Unable to attend: Mr A. Kumar, Drugs Controller General, Directorate-General of Health Services, Nirman Bhawan, New Delhi, India (Temporary Adviser); Dr B. Santoso, Regional Adviser, WHO Regional Office for the Western Pacific, Manila, Philippines; Dr K. Weerasuriya, Regional Adviser, WHO Regional Office for South-East Asia, New Delhi, India.


Dr R. Balocco-Mattavelli, Technical Officer, Quality Assurance and Safety: Medicines, Department of Essential Drugs and Medicines Policy, WHO, Geneva, Switzerland

Dr M. Chisale, Regional Adviser, WHO Regional Office for Africa, Harare, Zimbabwe

Ms F. Dansereau, Head, Inspection Unit, OCPC, Bureau of Compliance and Enforcement, Ottawa, Ontario, Canada (Temporary Adviser)

Dr E. Ehrin, WHO Collaborating Centre for Chemical Reference Substances, Central Laboratory, Kungens Kurva, Sweden (Temporary Adviser)

Dr E. Griffiths, Coordinator, Quality Assurance and Safety: Biologicals, Department of Vaccines and Biologicals, WHO, Geneva, Switzerland

Dr S. Kopp, Scientist, Quality Assurance and Safety: Medicines, Department of Essential Drugs and Medicines Policy, WHO, Geneva, Switzerland (Secretary)

Miss Y. Maruyama, Technical Officer, Traditional Medicine, Department of Essential Drugs and Medicines Policy, WHO, Geneva, Switzerland

Dr K. Morimoto, Scientist, Quality Assurance and Safety: Medicines, Department of Essential Drugs and Medicines Policy, WHO, Geneva, Switzerland

Dr P. Munderi, Technical Officer, Policy, Access and Rational Use, Department of Essential Drugs and Medicines Policy, WHO, Geneva, Switzerland

Dr E. Njau, Pharmaceutical Consultant, Arusha, United Republic of Tanzania (Temporary Adviser)

Dr C. Ondari, Technical Officer, Policy, Access and Rational Use, Department of Essential Drugs and Medicines Policy, WHO, Geneva, Switzerland

Dr A.M. Padilla, Quality and Safety of Plasma Derivatives and Related Substances, Department of Blood Safety and Clinical Technology, WHO, Geneva, Switzerland

Dr S. Phanouvong, Technical Officer, Policy, Access and Rational Use, Department of Essential Drugs and Medicines Policy, WHO, Geneva, Switzerland

Dr L.F. Ponce D’León, Department of Pharmacy, Faculty of Science, National University of Colombia, Bogotá, Colombia (Temporary Adviser)

Dr J.D. Quick, Director, Department of Essential Drugs and Medicines Policy, WHO, Geneva, Switzerland

Dr L. Rägo, Coordinator, Quality Assurance and Safety: Medicines, Department of Essential Drugs and Medicines Policy, WHO, Geneva, Switzerland

Dr V. Reggi, Scientist, Quality Assurance and Safety: Medicines, Department of Essential Drugs and Medicines Policy, WHO, Geneva, Switzerland

Dr S. Sur, Deputy Chief Inspector, State Inspectorate for Quality Control of Medicines, Ministry of Health, Kiev, Ukraine (Temporary Adviser)

Dr Y. Suzuki, Executive Director, Health Technology and Pharmaceuticals, WHO, Geneva, Switzerland

Dr K. Tamiya, Assistant Professional Officer, Quality Assurance and Safety: Medicines, Department of Essential Drugs and Medicines Policy, WHO, Geneva, Switzerland

Dr P. Vanbel, Technical Officer, Quality Assurance and Safety: Medicines, Department of Essential Drugs and Medicines Policy, WHO, Geneva, Switzerland

Mr A. van Zyl, Technical Officer, Quality Assurance and Safety: Medicines, Department of Essential Drugs and Medicines Policy, WHO, Geneva, Switzerland

Dr B. Vareldzis, Department of HIV/AIDS/STI, WHO, Geneva, Switzerland

Dr R.L. Williams, Executive Vice-President, The United States Pharmacopeia, Rockville, MD, USA (Temporary Adviser)

Mr E. Wondemagegnehu, Scientist, Quality Assurance and Safety: Medicines, Department of Essential Drugs and Medicines Policy, WHO, Geneva, Switzerland

Dr X. Zhang, Coordinator, Traditional Medicine, Department of Essential Drugs and Medicines Policy, WHO, Geneva, Switzerland

 

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