标准摘要
[中文适用范围]： 本文件为细胞治疗产品制造中快速微生物检测方法的选择和验证提供了指导、框架和基于风险的方法。 本文件提供了一个灵活的基于风险的框架，用于检测细胞治疗产品和细胞中间体中的微生物污染。 本文件提供了与细胞治疗产品制造相关的一般要求和风险，并灵活地解决每种独特细胞治疗产品的特定制造工艺的差异。 本文件主要讨论细胞治疗产品制造中的无菌测试。 本文件适用于其他细胞衍生治疗产品的生产。 本文件重点介绍用于过程中和最终产品测试的快速微生物测试方法 (RMTM)。 本文件不包括细胞治疗产品制造中的病毒测试。 [外文原描述]： This document provides guidance, a framework and a risk-based approach for the selection and validation of methods for rapid microbial detection in cellular therapeutic product manufacturing. This document provides a flexible risk-based framework for the detection of microbial contamination in cellular therapeutic products and cellular intermediates. This document provides general 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 is applicable to other cell-derived therapeutic product manufacturing. This document focuses on rapid microbial test methods (RMTMs) used for both in-process and final product testing. Viral testing in cellular therapeutic product manufacturing is not included in this document.
英文名称Biotechnology — Analytical methods — Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses