Requirements for Procedures Related to the Collection, Processing, Storage and Issue of HUMAN Haemopoietic Progenitor Cells (Third Edition 2009)
1. Quality management
Table of contents
- Scope
- Acronyms and abbreviations
- Definitions
- Introduction
1. Quality management
2. Donor evaluation and selection- 3. Cellular therapy product collection
- 4. Product processing
- 5. Cellular therapy product testing
- 6. Labelling
- 7. Cellular therapy storage areas
- 8. Cellular product issue and distraction
- 9. Transport and 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)
This section refers to the collection, processing, storage, issue and transport of HPC products and should be read in conjunction with the AS4633 (ISO 15189) Application Document. The quality management system relating to HPC infusion can be found in Appendix B, which complements this section.
