ICS03.120.10 CCSC00 团 体 标 准 T/ZJPA001-2022 口服缓控释制剂现场检查指南 Siteinspectionguidefororalsustained/controlled releasepreparations 2023-04-18发布 2023-05-01实施 浙江省医药行业协会发布 全国团体标准信息平台 T/ZJPA001-2022 I目次 前言........................................................................I 引言.......................................................................II 1范围......................................................................1 2规范性引用文件............................................................1 3术语和定义................................................................1 3.1口服缓控释制剂......................................................1 3.2现场检查............................................................1 3.3关键质量属性........................................................2 3.4关键批..............................................................2 3.5特殊风险............................................................2 3.6数据可靠性..........................................................2 4口服缓控释制剂概述........................................................2 4.1膜包衣型缓控释制剂..................................................2 4.1.1处方工艺......................................................2 4.1.2关键质量属性..................................................4 4.1.3需要进行的支持性研究..........................................4 4.1.4特殊风险......................................................4 4.2骨架型缓控释制剂....................................................4 4.2.1处方工艺......................................................4 4.2.2关键质量属性..................................................5 4.2.3需要进行的支持性研究..........................................5 4.2.4特殊风险......................................................6 5口服缓控释制剂研制现场核查要点............................................6 5.1质量管理............................................................6 5.1.1组织机构和人员................................................6 5.1.2研究条件......................................................6 5.1.3文件和记录....................................................6 5.1.4变更和偏差管理................................................6 5.1.5委托研究......................................................7 5.2场地与设施设备......................................................7 5.3处方工艺............................................................7 5.4样品试制............................................................9 5.5质量控制............................................................9 5.5.1质量控制研究..................................................9 5.5.2清洁方法开发.................................................10 5.6技术转移...........................................................10 5.6.1工艺转移.....................................................10 5.6.2极限条件研究.................................................10 5.6.3分析方法转移.................................................10 5.6.4稳定性方案设计...............................................11 5.6.5清洁方法转移.................................................11 5.7对照品和参比制剂...................................................11 5.8稳定性研究.........................................................11 全国团体标准信息平台 T/ZJPA001-2022 II5.9数据可靠性.........................................................11 6口服缓控释制剂生产现场检查要点...........................................12 6.1质量管理...........................................................12 6.2质量控制...........................................................13 6.2.1原辅料质量控制...............................................13 6.2.2中间产品质量控制.............................................13 6.2.3成品质量控制.................................................13 6.2.4持续稳定性考察...............................................14 6.3厂房与设施、设备...................................................15 6.3.1生产环境控制.................................................15 6.3.2批量放大的设备变化及验证.....................................15 6.4物料...............................................................16 6.5验证...............................................................16 6.5.1工艺验证.....................................................16 6.5.2清洁验证..................