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Requirements for Procedures Related to the Collection, Processing, Storage and Issue of HUMAN Haemopoietic Progenitor Cells (Third Edition 2009)

This is a publication of the National Pathology Accreditation Advisory Council (NPAAC) which is managed by the Australian Government Department of Health and Ageing

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ISBN: 1-74186-890-4

Online ISBN: 1-74186-891-2

Publications Approval Number: P3-5239

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© Commonwealth of Australia 2009

This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth. Requests and inquiries concerning reproduction and rights should be addressed to the Commonwealth Copyright Administration, Attorney-General's Department, Robert Garran Offices, National Circuit, Barton ACT 2600 or posted at http://www.ag.gov.au/cca

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© Commonwealth of Australia 2009

This work is copyright. You may download, display, print and reproduce this material in unaltered form only (retaining this notice) for your personal, non-commercial use or use within your organisation. Apart from any use as permitted under the Copyright Act 1968, all other rights are reserved. Requests and inquiries concerning reproduction and rights should be addressed to Commonwealth Copyright Administration, Attorney-General's Department, Robert Garran Offices, National Circuit, Barton ACT 2600 or posted at http://www.ag.gov.au/cca


First published 1998

Second edition 2004

Third edition 2009 reprinted with revisions and name change from Guidelines for Laboratory Procedures related to the Processing, Storage and Infusion of Cells for Transplantation or Cell Therapy

Australian Government Department of Health and Ageing

The National Pathology Accreditation Advisory Council (NPAAC) was established in 1979 to consider and make recommendations to the Australian, state and territory governments on matters related to the accreditation of pathology laboratories and the introduction and maintenance of uniform standards of practice in pathology laboratories throughout Australia. A function of NPAAC is to formulate standards and initiate and promote guidelines and education programs about pathology tests.

Publications produced by NPAAC are issued as accreditation material to provide guidance to laboratories and accrediting agencies about minimum standards considered acceptable for good laboratory practice.

Failure to meet these minimum standards may pose a risk to public health and patient safety.

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Table of Contents
Requirements for Procedures Related to the Collection, Processing, Storage and Issue of HUMAN Haemopoietic Progenitor Cells (Third Edition 2009)
  Scope
  Acronyms and abbreviations
  Definitions
  Introduction
  1. Quality management
   Quality management system
  2. Donor evaluation and selection
   Donor selection
   Donor testing
   Donor consent
  3. Cellular therapy product collection
   Collection facility
   Personnel
   Procedure
  4. Product processing
   Processing facility
   Personnel
   Procedures
  5. Cellular therapy product testing
   Routine processing
   Cryopreservation
  6. Labelling
   Procedures
   Collection label
   Final product issue label
   Outer transport container label
   Minimum label (partial label)
   Biohazard label
  7. Cellular therapy storage areas
   Cellular therapy storage areas
   Storage duration
   Temperature
   Product safety
   Monitoring of storage temperature
   Alarm systems
   Inventory control
  8. Cellular product issue and distraction
   Processing, tracking and issue criteria
   Distribution records
   Accompanying documentation at distribution
   Products issued under the provision of demonstrable medical need
   Return of cellular therapy products from issue
   Product recall
  9. Transport and disposal
   Transport
   Transport of cryopreserved products
   Transport records
   Disposal
  10. Adverse events
  11. Health and safety
  Bibliography
  Additional reading
  Appendices
  Appendix A (Part I - Normative, Part II - Informative)
  Appendix B (Normative and Informative)
  Appendix C (Informative)
  Appendix D (Informative)
  Appendix E (Normative)