GMP内审体系指引.doc

GMP 内审体系指引 目的 PURPOSE: 建立一个 DXC GMP内审的体系，保证企业的运行符合 cGMP的要求。 To establish an DXC GMP internal audit ’s system to make sure all operations in DXC T.O are in compliance with the cGMP. 用 TrackWise 作为管理审计报告的系统， 并跟踪所有相关行动 , 确保 DXC符合公司总部的指示和政策、 cGMP和产品分布地的政府法律机构所建立的要求。 Assure DXCis operating in compliance with corporate guidelines and policies, current GMP’ s and any other requirements established by the Regulatory Agencies where the products are distributed using TrackWise as the system to manage the audit report and follow up on all corrective actions. 范围 SCOPE: 需被审计的部门有： The departments need to be audited are: 制造部 ，工程部 ， QC，QA，仓储部 ，物控部 ，技术服务部 Lactam Workshop, Non-Lactam Workshop, Engineering Department, QC, QA, Warehouse, Material Management Department and Technical Service Department QA GMP月度审计包括下列内容，但不限于此： Monthly QA GMP internal audits must include, but not be restricted to: 工厂设施 Premises 维护 Maintenance 校验 Calibration 流向 Flow 标识系统 Labeling system 净化空调系统 HVAC system 工艺用水系统 WFI USP water system 设备 Equipment 维护 Maintenance 清洁 Cleaning 标识系统 Labeling system 状态控制 Status control 区域 Area 设备 Equipment 物料 Material 文件实施和版本控制 Ducumentation Practice revision control 标准操作程序 SOP 原始记录 MLS/PLS 测试标准、方法、记录 TS/TM/Report 批生产记录 Batch record 生产 Production 清场、清洁、环境控制 Housekeeping/cleaning/clearance/environmental control system 变动控制系统 CCF system 过程控制 Process management 中心称量室配料程序 Dispensing practices 质量保证 / 控制 QA/QC 异常情况 /OOS控制 Incident deviation control/OOS 验证（工艺、设备、水系统、空调系统、设备清洁） Validation (Process, equipment, Water system, HVAC system Equipment cleaning) 标准品、标准溶液、试剂和样品的管理 Reference standards, standard solution, reagents and samples management 稳定性考察和留样规则 Stability testing program, retain sample and storage 分析原始记录 Analytical worksheet 取样 Sampling procedure GMP培训和记录 GMP training and record 产品的储存、分发 Storage/Distribution of products 仓库中物料的隔离 Segregation of materials 标签贮存区域 Label storage area 温湿度控制 Temperature and humidity control 虫鼠控制 Pest/Mouse control 物料系统 Materials syste