ICS11.120.10 CCSC27 团 体 标 准 T/CQAP3015—2025 人间充质干细胞药品生产和质量 控制规范 Specificationforproductionandquality controlofhumanmesenchymalstemcelldrugs 2025-08-10发布 2025-11-10实施 中国医药质量管理协会发布 全国团体标准信息平台 I 全国团体标准信息平台 T/CQAP3015-2025 I目次 前言.............................................................................................................................................III 引言...............................................................................................................................................IV 1范围.................................................................................................................................................1 2规范性引用文件.............................................................................................................................1 3术语和定义.....................................................................................................................................1 4缩略语.............................................................................................................................................2 5总体要求.........................................................................................................................................2 6人员与培训.....................................................................................................................................2 6.1人员要求.............................................................................................................................3 6.2培训.....................................................................................................................................3 7厂房设施与设备.............................................................................................................................3 7.1厂房设施.............................................................................................................................3 7.2设备.....................................................................................................................................4 8生产用物料.....................................................................................................................................5 8.1一般要求.............................................................................................................................5 8.2原材料.................................................................................................................................5 8.3辅料.....................................................................................................................................7 8.4接触性耗材、容器和包装材料.........................................................................................7 9目标产品质量概况.........................................................................................................................8 10生产工艺.......................................................................................................................................8 10.1工艺开发...........................................................................................................................8 10.2工艺和优化.......................................................................................................................9 10.3工艺变更.........................................................................................................................11 10.4工艺验证.........................................................................................................................11 11质量控制.....................................................................................................................................12 11.1关键质量属性.................................................................................................................12 11.2质量标准.........................................................................................................................14 11.3质量放行控制......................................................................