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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 - C.Th. Smit Sibinga

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

By: C.Th. Smit Sibinga (Editor), P. C. Das (Editor), H. J. Heiniger (Editor)

Hardcover Published: 31st August 1994
ISBN: 9780792330097
Number Of Pages: 293

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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. This publication addresses the various implications of the implementation of these concepts upon transfusion medicine. 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 organizational structure of blood transfusion in the future.

Introduction. TQM and Taylorism; How They Compare
State of The Art and Future Directions. A Brief Overviewp. 3
Definitions in Quality Assurance and Quality Managementp. 13
The Quality Assurance Conceptp. 17
The Good Manufacturing Practice Conceptp. 25
Error Policies and Audit Systems in Transfusion Medicinep. 35
European Community Action on Good Manufacturing Practice: Consumer Protection and Product Liabilityp. 59
Regulatory Systems and Mechanismsp. 67
Good Manufacturing Practice and Blood Derivatives: Requirements and Mechanisms for Product Licensingp. 75
Standards and External Quality Audit Systemsp. 85
Blood Transfusion Committees and Other Approaches to Improving Clinical Transfusion Practicep. 129
Teaching and Training of Personnel: Good Manufacturing Practicesp. 149
Good Manufacturing Practice in Transfusion Medicine: Job Descriptions and Standard Operating Proceduresp. 161
Blood and Plasma Processing: Facilities and Physical Requirementsp. 169
Documentation and Record Keeping: The Key to Compliancep. 177
Validation Procedures and Internal Audit Systemsp. 195
Quality Control and Release Procedures for Products Derived from Human Blood or Human Plasma. Application to Pasteurized Plasmap. 205
A Plant for the Manufacturing of Virus Inactivated Plasma According to GMP-guidelinesp. 215
Bar Coding in Health Care: The Needs of the Blood Banksp. 221
Good Clinical (research) Practicep. 233
Error Policies at the Bedside. Quality Management of Blood Transfusion in Dutch Hospitalsp. 253
Consensus Protocols for Supportive Hemotherapyp. 263
Hospital Blood Transfusion Audit Systemsp. 269
Discussionp. 281
Indexp. 291
Table of Contents provided by Blackwell. All Rights Reserved.

ISBN: 9780792330097
ISBN-10: 0792330099
Audience: Professional
Format: Hardcover
Language: English
Number Of Pages: 293
Published: 31st August 1994
Publisher: Springer
Country of Publication: NL
Dimensions (cm): 25.4 x 17.15  x 1.27
Weight (kg): 0.68