Good Manufacturing Practice in Transfusion Medicine

Introduction. TQM and Taylorism; How they Compare; H. Bremer. I: Principles of Good Manufacturing Practice (GMP). State of the Art and Future Directions. A Brief Overview; H.J. Heiniger. Definitions in Quality Assurance and Quality Management; C.Th. Smit Sibinga, W.P.A. van der Tuuk Adriani. The Quality Assurance Concept; J.L. Robins. The Good Manufacturing Practice Concept; T.F. Zuck. Error Polcies and Audit Systems in Transfusion Medicine; K. Sazama. II: Legislative and Regulatory Aspects. European Community Action on Good Manufacturing Practice: Consumer Protection and Product Liability; L. Gormley. Regulatory Systems and Mechanisms; H.I. Hannema. Good Manufacturing Practice and Blood Derivatives: Requirements and Mechanisms for Product Licensing; J.M. Noel, Y. Dumas. Standards and External Quality Audit Systems; P.A. Hoppe. Blood Transfusion Committees and Other Approaches to Improving Clinical Transfusion Practice; D.B.L. McClelland. III: Processing, Manufacturing and Quality Control Aspects. Teaching and Training of Personnel: Good Manufacturing Practices; T.A. Caglioti. Good Manufacturing Practice in Transfusion Medicine: Job Descriptions and Standard Operating Procedures; B.T. Teague. Blood and Plasma Processing: Facilities and Physical Requirements; S. Arnoldussen. Documentation and Record Keeping: the Key to Compliance; D.E. Nevalainen. Validation Procedures and Internal Audit Systems; B. Cuthbertson. Quality Control and Release Procedures for Products Derived from Human Blood or Human Plasma. Application to Pasteurized Plasma; B. Flan, T. Burnouf, J.J. Huart. A Plant for the Manufacturing of Virus Inactivated Plasma According to GMP-Guidelines; B. Kerner, P. Selosse. Bar Coding in Health Care: the Needs of the Blood Banks; H. Oehlmann. IV: Good Clinical Practice (GCP). Good Clinical (Research) Practice; F. Wells. Error Policies at the Bedside. Quality Management of Blood Transfusion in Dutch Hospitals; N.S. Klazinga. Consensus Protocols for Supportive