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

TQM AND TAYLORISM; HOW THEY COMPARE H. Bremer Preface The industrial world today is divided between two camps: a culture based on the principles of Total Quality Management (TQM), developed in the Far East, and one still strongly influenced by the origins of "Scientific Management", intro­...

Full description

Bibliographic Details
Other Authors: Smit Sibinga, C.Th (Editor), Das, P.C. (Editor), Heiniger, H.J. (Editor)
Format: eBook
Language:English
Published: New York, NY Springer US 1994, 1994
Edition:1st ed. 1994
Series:Developments in Hematology and Immunology
Subjects:
Online Access:
Collection: Springer Book Archives -2004 - Collection details see MPG.ReNa
Table of Contents:
  • 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