The fourth edition of Standards for Cellular Therapy Product Services (CT Standards) contains detailed requirements for cellular therapy product procurement, processing, storage and final distribution, in addition to requirements for analysis of patient outcomes data. Organized according to the Core 10 quality template, the CT Standards addresses operational aspects such as the determination of donor eligibility, product labeling and other critical functions.
New or expanded sections of this edition of CT Standards include:
- New storage temperature requirement for cryopreserved cord blood products.
- Use of ISBT 128 terminology.
- Revised donor eligibility requirements.
- Updated regulatory references.