Expand Document  |  Expand Chapter  |  Full TOC  |  Printable HTML version
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
 

WHO Expert Committee on Specifications for Pharmaceutical Preparations

Geneva, 21-25 April 1997

Members

Professor I. Addae-Mensah, Chancellor, University of Ghana, Legon, Ghana (Rapporteur)

Professor A.A. Haggag, Vice-Dean, Faculty of Pharmacy, University of Tanta, Tanta, Egypt

Dr M.K. Majumdar, Director, Central Drugs Laboratory, WHO Collaborating Centre for Quality Assurance of Essential Drugs, Calcutta, India

Professor T.L. Paál, Director-General, National Institute of Pharmacy, WHO Collaborating Centre for Drug Information and Quality Assurance, Budapest, Hungary

Miss M.L. Rabouhans, Scientific Editor-in-Chief, British Pharmacopoeia Commission, London, England (Chairperson)

Dr Y. Takeda, Senior Managing Director, Society of Japanese Pharmacopoeia, Tokyo, Japan

Dr R.L. Williams, Deputy Director, Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD, USA

Professor Yang Zhong-Yuan, Director, Guangzhou Municipal Institute for Drug Control, Guangzhou, China (Vice-Chairperson)

Representatives of other organizations*

* Unable to attend: European Commission (EC), Brussels, Belgium; Pharmaceutical Inspection Convention (PIC), Geneva, Switzerland; United Nations Industrial Development Organization (UNIDO), Vienna. Austria; United Nations International Drug Control Programme (UNDCP), Vienna, Austria.

 

Commonwealth Pharmaceutical Association (CPA) and International Pharmaceutical Federation (FIP)

Professor H.H. Blume, Head, Central Laboratory of German Pharmacists, Eschborn, Germany

International Federation of Pharmaceutical Manufacturers Associations (IFPMA)

Miss M. Cone, Vice-President for Scientific Affairs, Geneva, Switzerland

Dr O. Morin Carpentier, Manager, Pharmaceutical and Biological Affairs, Geneva, Switzerland

World Federation of Proprietary Medicine Manufacturers (WFPMM)

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

Secretariat

Mr J.A. Halperin, Executive Vice President and Chief Executive Officer, United States Pharmacopeia, Rockville, MD, USA (Temporary Adviser)

Dr J. Idänpään-Heikkilä, Director, Division of Drug Management and Policies, WHO, Geneva, Switzerland (Secretary)

Dr S. Kopp-Kubel, Responsible Officer (a.i.), Quality Assurance, Division of Drug Management and Policies, WHO, Geneva, Switzerland

Professor H.G. Kristensen, Department of Pharmaceutics, The Royal Danish School of Pharmacy, Copenhagen, Denmark (Temporary Adviser)

Dr T.P. Layloff, Director, Division of Testing and Applied Analytical Development, Food and Drug Administration, St Louis, MO, USA (Temporary Adviser)

Dr A.P. Mechkovski, Moscow, Russian Federation (Consultant)

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

Mr M.G. Moester, Senior Inspector of Health Care, Department of Health, Rijswijk, Netherlands (Temporary Adviser)

Ms M. Schmid, Technical Officer, Quality Assurance, Division of Drug Management and Policies, WHO, Geneva, Switzerland

Ms A. Wehrli, Chief, Regulatory Support, Division of Drug Management and Policies, WHO, Geneva, Switzerland

Mrs M. Westermark, Director, WHO Collaborating Centre for Chemical Reference Substances, Apoteksbolaget AB, National Corporation of Swedish Pharmacies, Central Laboratory, Stockholm, Sweden (Temporary Adviser)

 

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: October 7, 2014