scope:

This document provides definitions, guidelines, a framework and a risk-based approach for the design, selection and validation for methods for rapid microbial detection cellular therapeutic product manufacturing. This document contains the generalized requirements and risks associated with cellular therapeutic product manufacturing, with flexibility to address differences in specific manufacturing processes of each unique cellular therapeutic product. This document primarily addresses sterility testing in cellular therapeutic product manufacturing. This document can be applied to other cell derived therapeutic product manufacturing. This document focuses on rapid microbial test methods (RMTMs) used in both in-process and final product testing. Viral testing in cell-based therapy manufacturing is not included in this document.