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 (Hardcover, 1994 ed.)

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.

General

Imprint:	Springer
Country of origin:	Netherlands
Series:	Developments in Hematology and Immunology, 29
Release date:	2001
First published:	1994
Editors:	C.Th.Smit Sibinga • P.C. Das • H.J. Heiniger
Dimensions:	234 x 156 x 19mm (L x W x T)
Format:	Hardcover
Pages:	293
Edition:	1994 ed.
ISBN-13:	978-0-7923-3009-7
Categories:	Books > Medicine > Other branches of medicine > Pharmacology > General
LSN:	0-7923-3009-9
Barcode:	9780792330097

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