Standards for Cellular Therapy Services, 11th edition – print

The 11th edition of Standards for Cellular Therapy Services (“CT Standards”), effective July 1, 2023, details the latest standards of practice for accredited cellular therapy facilities and includes overarching quality standards as well as specific technical standards.

Significant changes to the 11th edition include:

• The Cellular Therapies Standards Committee created new Standard 1.2.3.1.1 for completeness. The new standard ensures that the signature method in use in the facility is concordant with those in the country where these standards are being implemented.
• Specifically in Chapter 4 and throughout the edition, the Committee added the concepts of the maintenance of “chain of identity” and “chain of custody” as a part of agreements and records.
• New Standard 4.1.2.4 now requires that facilities involved in an agreement share any nonconformances to the relevant regulatory institutions where appropriate.
• New Standard 4.3.6 requires that suppliers be qualified when cellular therapy services involve more than one facility.
• New Standard 4.5.5.2 now includes the concept of having a qualified interpreter involved in the donor informed consent process where appropriate. This requires that facilities have all the tools necessary to ensure that donors are fully aware of what will occur and what is expected of them.
• New Standard 5.3.2.1 was included to ensure that the collection of outcomes data be done at facility-defined intervals.
• New Standard 5.8.4 was created to ensure that these Standards include a requirement for facilities that use investigational products being approved for use and labeled according to Competent Authority requirements.
• The Committee added new entry 14 Reference Standard 5.8.2A to ensure that products from donors who are CMV positive are identified as such and the product indicates as much on the accompanying label. This ensures that facilities test donors for CMV and label accordingly with these Standards.
• Reference Standard 5.12B now requires HLA-C testing for all allogeneic donors with regard to HLA type where applicable.
• New Standard 7.2.1 requires that facilities perform lookback procedures in the case of an identified nonconformance.

(2023, AABB, softcover, 187 pages, ISBN 978-1-56395-466-5) Effective date: July 1, 2023

Nonmember price: $287

Member price: $197

Item Details:

View Table of Contents (pdf)

View Preface (pdf)

View Sample Pages (pdf)