辽宁省地方标准ICS11.120.10 CCSC10 21 药物警戒检查管理规范 Managementspecificationonthepharmacovigilanceinspections 2024-05-30发布 2024-06-30实施 辽宁省市场监督管理局  发布DB21/T3972—2024 DB21/T3972—2024 I目次 前言..................................................................................II 1范围................................................................................1 2规范性引用文件......................................................................1 3术语和定义..........................................................................1 4缩略语..............................................................................1 5总则................................................................................2 5.1检查原则........................................................................2 5.2检查依据........................................................................2 6机构和人员..........................................................................2 6.1派出检查单位....................................................................2 6.2检查人员........................................................................2 7检查内容............................................................................3 7.1检查重点考虑因素................................................................3 7.2检查范围........................................................................3 7.3检查方式........................................................................3 8检查流程............................................................................3 8.1基本流程........................................................................4 8.2检查前准备......................................................................4 8.3检查实施........................................................................4 8.4整改确认........................................................................6 8.5综合评定........................................................................6 9档案管理............................................................................6 附录A（资料性）检查依据文件清单.....................................................8 附录B（资料性）药物警戒应知应会知识.................................................9 附录C（规范性）药物警戒检查细则....................................................30 附录D（资料性）药物警戒检查报告示例................................................55 附录E（资料性）检查组与被检查单位存在异议的问题记录示例............................57 参考文献..............................................................................58