Guidance for Standards for Hematopoietic Progenitor Cell and Cellular Product Services

Guidance for Standards for Hematopoietic Progenitor Cell and Cellular Product Services

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Description

This Guidance document will assist the users in their efforts to implement the Standards for Hematopoietic Progenitor Cells and Cellular Products and Services in their facilities. It is formatted to address general quality management requirements, as well as technical guidance for certain specific standards and provides guidance and rationales for new and changed standards. Developed by the HPC Standards Program Unit, this guidance is based on questions submitted by members, assessors, and other sources of input.show more

Product details

  • Paperback | 88 pages
  • S Karger Ag
  • Basel, Switzerland
  • Revised
  • 3rd Revised edition
  • 3805578032
  • 9783805578035

Table of contents

Introduction; 1. Management Responsibility; 2. Quality System; 3. Agreement Review; 4. Design Control; 5. Document Control; 6. Obtaining Materials (Including HPCs and Cellular Products) and Services; 7. Control of Patient-Specific (Autologous or Related Allogeneic) Products; 8. Product and Sample Identification and Traceability; 9. Process Control; 10. Inspection and Testing; 11. Control of Equipment; 12. Inspection and Test Status; 13. Deviations and Nonconforming Products and Services; 14. Corrective and Preventive Action Plans; 15. Storage, Distribution, and Transportation; 16. Control of Records; 17. Quality Assessments; 18. Training; 19. Statistical Techniques; 20. Safety; Glossary; Appendix I-IIIshow more