I ICS11.120.01 C2761 团体标准 T/QMHIPA001-2022 细胞制备中心建设与管理规范 SpecificationsForEstablishmentandManagement ofCellPreparationCenter 2022-1-10发布 2022-1-10实施 青岛市医养健康产业促进会发布 全国团体标准信息平台 II前言 本标准由青岛市医养健康产业促进会提出和归口。 本标准起草单位：青岛海尔生物科技有限公司、深圳华大基因细胞生物科技有限责任公司、青岛赛 尔斯干细胞库有限公司、青岛华赛伯曼医学细胞生物有限公司、青岛中康原能生物科技有限公司、 青岛瑞思德生物科技有限公司。 本标准主要起草人：曹启龙、黄建华、初相伍、李云霄、郭晶、李慧、苑志欣、郝利利、李栋、刘 成龙、于亚平、张炳强、王春亮、刘文娜。 本标准为首次发布。 全国团体标准信息平台 III目录 前言.......................................................................................................................................................................II 目录......................................................................................................................................................................III 1范围.................................................................................................................................................................1 2规范性引用文件.............................................................................................................................................1 3术语和定义.....................................................................................................................................................2 4缩略语.............................................................................................................................................................4 5机构设置和生命伦理.....................................................................................................................................4 6人员管理.........................................................................................................................................................6 7中心设计总体要求.........................................................................................................................................7 7.1中心设计原则.........................................................................................................................................7 7.2中心的功能分区.....................................................................................................................................7 7.3建筑要求.................................................................................................................................................7 7.4环境要求.................................................................................................................................................8 7.5装修装饰要求.........................................................................................................................................9 7.6设施设备要求.........................................................................................................................................9 7.7细胞储存区要求...................................................................................................................................11 8管理要求.......................................................................................................................................................11 8.1设备管理...............................................................................................................................................11 8.2物料管理...............................................................................................................................................13 8.3样本运输...............................................................................................................................................14 8.4样本接收...............................................................................................................................................14 8.5制备过程控制.......................................................................................................................................15 8.6质量检测...............................................................................................................................................15 8.7质量保证..................................................