Requirements for Procedures Related to the Collection, Processing, Storage and Issue of HUMAN Haemopoietic Progenitor Cells (Third Edition 2009)
Scope
- 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)
These requirements specify the standards and guidelines for quality and competency for laboratories and other facilities involved in donor selection, collection, processing, storage and issue or disposal of haemopoietic progenitor cells (HPC) and lymphocytes used for cellular therapy. Requirements for other clinical activities of transplantation facilities are outside the parameters of this document; however, guidelines for medical and allied staff, training, therapy administration, clinical research, infusion of HPCs and related policy and procedures requirements are included in Appendices A, C, D and E. Appendix B relates to a quality framework, which may be used as a guideline for collection facilities.
