DANSK DSF/ISO/FDIS 23033 PDF

This document defines terms and provides general requirements for the testing of cellular therapeutic products intended for human use. This document also provides considerations for the characterization and testing of cellular therapeutic products, including approaches to select and design analytical methods that are fit for purpose, and considerations for setting specifications for the analytical methods. Such considerations can be used to establish critical quality attributes (CQAs) for a cellular therapeutic product. Aspects of this document are applicable to starting materials (including those for tissue engineered products) and intermediates of cellular therapeutic products. This document excludes tissues used in transplantation.