Title | Good Manufacturing Practice in Transfusion Medicine [electronic resource] : Proceedings of the Eighteenth International Symposium on Blood Transfusion, Groningen 1993, organized by the Red Cross Blood Bank Groningen-Drenthe / edited by C. Th. Smit Sibinga, P. C. Das, H. J. Heiniger |
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Imprint | Boston, MA : Springer US : Imprint: Springer, 1994 |
Connect to | http://dx.doi.org/10.1007/978-1-4615-2608-7 |
Descript | XX, 293 p. 6 illus. online resource |
I. Principles of Good Manufacturing Practice (GMP) -- State of The Art and Future Directions. A Brief Overview -- Definitions in Quality Assurance and Quality Management -- The Quality Assurance Concept -- The Good Manufacturing Practice Concept -- Error Policies and Audit Systems in Transfusion Medicine -- Discussion -- II. Legislative and Regulatory Aspects -- European Community Action on Good Manufacturing Practice: Consumer Protection and Product Liability -- Regulatory Systems and Mechanisms -- Good Manufacturing Practice and Blood Derivatives: Requirements and Mechanisms for Product Licensing -- Standards and External Quality Audit Systems -- Blood Transfusion Committees and Other Approaches to Improving Clinical Transfusion Practice -- Discussion -- III. Processing, Manufacturing and Quality Control Aspects -- Teaching and Training of Personnel: Good Manufacturing Practices -- Good Manufacturing Practice in Transfusion Medicine: Job Descriptions and Standard Operating Procedures -- Blood and Plasma Processing: Facilities and Physical Requirements -- Documentation and Record Keeping: The Key to Compliance -- Validation Procedures and Internal Audit Systems -- Quality Control and Release Procedures for Products Derived from Human Blood or Human Plasma. Application to Pasteurized Plasma -- A Plant for the Manufacturing of Virus Inactivated Plasma According to GMP-guidelines -- Bar Coding in Health Care: The Needs of the Blood Banks -- Discussion -- IV. Good Clinical Practice (CGP) -- Good Clinical (research) Practice -- Error Policies at the Bedside. Quality Management of Blood Transfusion in Dutch Hospitals -- Consensus Protocols for Supportive Hemotherapy -- Hospital Blood Transfusion Audit Systems -- Discussion