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Authors

The drafts of these guidelines were prepared by:

Dr T. Burnouf, Human Plasma Product Services, Lille, France; Dr A. Padilla, World Health Organization, Geneva, Switzerland; Dr C. Schärer, Swissmedic, Swiss Agency for Therapeutic Products, Bern, Switzerland; Dr T. Snape, Consultant, Pickering, North Yorkshire, UK; Dr P. Strengers, International Society of Blood Transfusion, Amsterdam, the Netherlands; Professor S. Urbaniak, Regional Transfusion Centre, Aberdeen, UK; Professor W.G. van Aken, Professor of Medicine, Amsterdam, the Netherlands.

The Drafts prepared were circulated for Consultation to Representatives of National Regulatory Authorities, National Blood Programs and to the respective WHO Regional Advisors in all the WHO Regional Offi ces. Plasma fractionators were consulted through their respective plasma fractionation associations or through the regulatory agencies in their countries. Both the Plasma Protein Therapeutic Association and the International Plasma Fractionation Association presented consolidated comments of their Members.

Acknowledgements are due to the following experts for their comments, advice and information given during the preparation and consultation process of these Guidelines:

Lic. M. P. Alvarez, Departamento Biológicos, CECMED, Havana, Cuba; Dr. R. S. Ajmani, Intas Pharmaceuticals Ltd, Chinubhai Centre, Ahmedabad, India; Dr D. Armstrong, Natal Bioproducts, South Africa; Dr. T. Barrowcliffe, National Institute for Biological Standards, Potters Bar, Herts, UK; Dr C. Bianco, America's Blood Centers, Washington DC, USA; Dr R. Büchel, Plasma Protein Therapeutics Association (PPTA) Source, Brussels, Belgium; Dr E. A. Burgstaler, Transfusion Medicine, Mayo Clinic, Rochester, Minnesota, USA; Mr A. Cadiz, Empresa Productora de Sueros y Hemoderivados, La Habana, Cuba; Dr F. Cardoso de Melo, Agencia Nacional de Vigilancia Sanitaria, Ministerio da Saude, Brasilia, Brazil; Dr B. Cuthbertson, Scottish National Blood Transfusion Service, Edinburgh, UK; Dr A. M. Cheraghali, Iran Blood Transfusion Organization, Tehran, Iran; Dr N. Choudhury, Prathama Blood Center, Vasna, Ahmedabad, India; Dr J. R. Cruz, Regional Advisor Laboratory and Blood Services, AMRO/PAHO, Washington, USA; Dr. F Décary, Héma-Québec, Canada; Dr N. Dhingra, World Health Organization, Geneva, Switzerland; Dr R. Dodd, American Red Cross, USA; Dr J. Epstein, Offi ce of Blood Research and Review, FDA Center for Biologics Evaluation and Research, Bethesda, Maryland, USA; Mr T. Evers, International Plasma Fractionation Association (IPFA), Amsterdam, the Netherlands; Ms M. Farag, Egyptian Regulatory

Authority, Cairo, Egypt; Professor A. Farrugia, Offi ce of Devices, Blood and Tissues, Therapeutic Goods Administration, Woden, Australia; Dr B. Flan, Laboratoire Français du Fractionnement et des Biotechnologies, les Ulis, France; Dr J. C. Goldsmith, Offi ce of Blood Research and Review, FDA Center for Biologics Evaluation and Research, Bethesda, Maryland, USA; Ms K. Gregory, AABB, Bethesda, MD, USA; Ms M. Gustafson, Plasma Protein Therapeutics Association, Washington, USA; Mrs T. Jivapaisarnpong, Department of Medical Sciences,

Ministry of Public Health, Nonthaburi, Thailand; Dr H. Klein, National Institutes of Health, Clinical Research Center, Transfusion Medicine, Bethesda, MD, USA; Dr. J. Kurz, Federal Ministry of Health and Women, Medicines & Medical Devices Inspectorate, Vienna, Austria; Professor J. Löwer, Paul Ehrlich Institute, Langen, Germany; Mrs B. Mac Dowell Soares, Agencia Nacional de Vigilancia Sanitaria, Brasilia, Brazil; Dr E. Al Mansoori, Drug Control Department, Ministry of Health, United Arab Emirates; Dr M. Maschio, Plan Nacional de Sangre, Buenos Aires, Argentina; Dr A. Miller, Blood National Program, Montevideo, Uruguay; Dr S. Park, Korea Food and Drug Administration, Seoul, South Korea; Professor I. Peake, International Society on Thrombosis and Haemostasis, University of Sheffi eld, Sheffi eld, UK; Dr F. Reigel, Swissmedic, Swiss Agency for Therapeutic Products, Bern, Switzerland; Dr A. Robinson, NHS Blood and Transplant, National Health Service, UK; Mr D. Sato, Ministry of Health and Welfare, Japan; Professor E. Seifried, German Red Cross, Institute of Transfusion Medicine and Immunohaematology, Frankfurt/Main, Germany; Professor R. Seitz, Paul Ehrlich Institute, Langen, Germany; Dr G. Silvester; European Medicines Evaluation Agency, London, UK; Dr L. S. Slamet, National Agency of Drug and Food Control, Indonesia; Dr T Simon, Tricore, USA; Professor J.-H. Trouvin, Afssaps, Paris, France; Dr F. Vericat, Grifols, Barcelona, Spain; Dr E. Voets, Biological Standardization, Scientifi c Institute of Public Health, Federal Public Service Health, Brussels, Belgium; Professor G. N. Vyas, University of California, San Francisco, California, USA; Dr M. Weinstein, Offi ce of Blood Research and Review, FDA Center for Biologics Evaluation and Research, Rockville, Maryland, USA; Mrs M. Wortley, Haemonetics, Braintree USA; Professor H. Yin, Biological Products, State of Food and Drug Administration, Beijing, People’s Republic of China; Dr Mei-Ying Yu, Offi ce of Blood Research and Review, FDA Center for Biologics Evaluation and Research, Rockville, Maryland, USA.

Special thanks are also due to Dr T. Burnouf for the compilation and professional follow up of the signifi cant number of contributions received during the Consultation process. Dr T. Burnouf and Dr A. Padilla, WHO Project Leader prepared the fi nal manuscript of these Guidelines.

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