Quality Management and Good Manufacturing Practices for Hematopoietic Progenitor Cell Banks

Highlighting the FDA's intention to apply cGMP to the collection and processing of haematopoietic progenitor, this book explores applications of TQM and cGMP concepts to optimize patient care with haematopoietic progenitor cells, and anticipated regulatory and accreditation requirements.

---

The FDA's intention to apply cGMP to the collection and processing of haematopoietic progenitor cells further indicates the importance of the concepts of maintaining a validated process for using competent, trained staff operating under standard procedures. Ongoing developmental activities in this area, however, require some hybridization of R & D and manufacturing approaches for sustainable yet continually improving clinical success. This syllabus explores applications of TQM and cGMP concepts to optimize patient care with haematopoietic progenitor cells, and anticipated regulatory and accreditation requirements.