scope:

This document provides general requirements for the testing of cellular therapeutic products intended for human use.

This document also provides considerations for the characterization of cellular therapeutic products, including approaches to select and design analytical methods that are fit for purpose.

Such considerations can be used to establish critical quality attributes for a cellular therapeutic product.

This document is applicable to cellular starting materials (including those for tissue engineered products) and intermediates of cellular therapeutic products.

This document is not applicable to tissues used in transplantation.