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: Developments in Hematology and Immunology, cartea 29
Editat de C.Th. Smit Sibinga, P.C. Das, H.J. Heinigeren Limba Engleză Hardback – 31 aug 1994
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Specificații
ISBN-13: 9780792330097
ISBN-10: 0792330099
Pagini: 293
Ilustrații: XX, 293 p. 6 illus.
Greutate: 0.63 kg
Ediția:1994
Editura: Springer Us
Colecția Springer
Seria Developments in Hematology and Immunology
Locul publicării:New York, NY, United States
ISBN-10: 0792330099
Pagini: 293
Ilustrații: XX, 293 p. 6 illus.
Greutate: 0.63 kg
Ediția:1994
Editura: Springer Us
Colecția Springer
Seria Developments in Hematology and Immunology
Locul publicării:New York, NY, United States
Public țintă
ResearchCuprins
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.