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Books > Medicine > Clinical & internal medicine > Haematology
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Good Manufacturing Practice in Transfusion Medicine - Proceedings of the Eighteenth International Symposium on Blood Transfusion, Groningen 1993, organized by the Red Cross Blood Bank Groningen-Drenthe (Paperback, Softcover reprint of the original 1st ed. 1994)
Loot Price: R4,022
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Good Manufacturing Practice in Transfusion Medicine - Proceedings of the Eighteenth International Symposium on Blood Transfusion, Groningen 1993, organized by the Red Cross Blood Bank Groningen-Drenthe (Paperback, Softcover reprint of the original 1st ed. 1994)
Series: Developments in Hematology and Immunology, 29
Expected to ship within 18 - 22 working days
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Transfusion medicine provides an excellent bridge connecting the
healthy community donors with the patient's needs at the bedside;
the dominant philosophy has been on patient care and science, but
it is now realised that blood banks manufacture increasing amounts
of blood components to administer to patients -- a role analogous
to manufacturing functions. The concept of Good Manufacturing
Practice (GMP) is therefore relatively new. While quality has
always been important, the impact of GMP, Total Quality Management
(TQM) and Quality Assurance (QA) will be profound. As the
regulatory agencies, like the FDA in the U.S.A. and the EEC
Commission in Europe, increase their enforcement activities,
doctors, technical experts and managers will have to face many
issues of quality assurance including documentation, validation,
audit system, regulatory laws, licensing, teaching and training of
staff and their job descriptions, standards, processing facilities,
procedure validations, automation, record keeping, internal and
external quality control of products and their release.The
expansion of this philosophy to include Good Clinical Practice
(GCP) is an even greater challenge demanding consensus therapy
protocols and quality management of transfusion through auditing by
the hospital transfusion committees. Such comprehensive plans will
profoundly affect the financial and organisational structure of
blood transfusion in the future.
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