ISO/TS 20399-3:2018 生物技术 细胞治疗产品生产过程中的辅助材料 第3部分：辅助材料使用者的最佳实践指南

标准编号：ISO/TS 20399-3:2018

中文名称：生物技术 细胞治疗产品生产过程中的辅助材料 第3部分：辅助材料使用者的最佳实践指南

英文名称：Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 3: Best practice guidance for ancillary material users

发布日期：2018-11

标准范围

本文件为辅助材料（AM）用户提供指导。适用于细胞治疗产品，包括细胞构成最终产品一部分的基因治疗产品。它不适用于没有电池的产品。本文件主要关注生物（人类和动物）来源的辅助材料（AMs）及其潜在杂质和污染物。注1:图1中的决策图说明了本文件范围的基本原理。然而，多种生物来源，包括植物、昆虫和海洋生物，也可用于细胞治疗产品的开发。因此，风险管理的基本原则也适用于这些AMs来源。本文件不包括起始材料和赋形剂的选择、评估或控制。然而，预计这些仍然包括在一般风险管理程序中。本文件适用于临床开发和供应的所有阶段的用户；然而，在开发的早期阶段实施这些建议可以获得最大的好处。注2:国际、地区或国家法规或要求也可适用于本文件所涵盖的特定主题。

This document provides guidance for ancillary material (AM) users. It is applicable to cellular therapeutic products, including those gene therapy products whereby cells form part of the final product. It does not apply to products without cells.This document focuses primarily on ancillary materials (AMs) of biological (human and animal) origin and their potential impurities and contaminants.NOTE 1 The decision chart in Figure 1 illustrates the rationale underlying the scope of this document.However, diverse biological sources, including plants, insects and marine organisms, can also be used in the development of a cellular therapeutic product. Therefore the fundamental principles of risk management also apply for these sources of AMs.This document does not cover the selection, assessment or control of starting materials and excipients. However, it is anticipated that these are still covered by general risk management procedures.This document is applicable for users at all stages of clinical development and supply; however maximum benefits can be gained by the implementation of the recommendations in the early stages of development.NOTE 2 International, regional or national regulations or requirements can also apply to specific topics covered in this document.

标准预览图