ICS 07.080A40SZDB/Z深 圳 市标 准 化 指 导性 技 术 文 件SZDB/Z 188-2016 细胞制备中心建设与管理规范 Specifications for establishment and management of cellular therapy product manufacturing facility 2016-06-14发布2016-07-01实施发 布深圳市市场监督管理局 SZDB/Z 188-2016目次前言 ................................................................................ II1范围 .............................................................................. 12规范性引用文件 .................................................................... 13术语和定义 ........................................................................ 14建设要求 .......................................................................... 24.1总体原则 ........................................................................ 34.2功能分区 ........................................................................ 34.3建筑要求 ........................................................................ 34.4环境要求 ........................................................................ 44.5装修装饰要求 .................................................................... 44.6设施设备要求 .................................................................... 44.7细胞储存区要求 .................................................................. 65中心设置和人员要求 ................................................................ 65.1设置原则及要求 .................................................................. 65.2关键人员职责及能力要求 .......................................................... 66管理要求 .......................................................................... 76.1人员管理 ........................................................................ 76.2设备管理 ........................................................................ 86.3物料管理 ........................................................................ 96.4过程控制 ....................................................................... 106.5标签与编码管理 ...........................