Good Manufacturing Practice in Transfusion Medicine

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.