Good Manufacturing Practice in Transfusion Medicine
Subtitle: Proceedings of the Eighteenth International Symposium on Blood Transfusion, Groningen 1993, organized by the Red Cross Blood Bank Groningen-Drenthe
By: edited by C. Th. Smit Sibinga, P. C. Das, H. J. Heiniger
Contributors: Das, P. C.; Heiniger, H. J.
Series: Developments in Hematology and Immunology -- 29; Developments in hematology and immunology -- 29.
Publisher: Springer US
Published: 1994
Place of publication: Boston, MA
Language: eng
Format: [electronic resource] :
Number of pages: 293
ISBN-13: 9781461361176; 9781461526087
Subjects: Medical laboratories; Information Systems; Computer science; Hematology
Other titles: Proceedings of the Eighteenth International Symposium on Blood Transfusion, Groningen 1993, organized by the Red Cross Blood Bank Groningen-Drenthe
Description: 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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