Auditing Checklist_Solid Dosage FDA口服制剂检查条款 中英文.doc

INDEX A. OVERVIEW概述 B. INCOMING MATERIALS CONTROL进厂物料控制 C. RAW MATERIAL WAREHOUSING/INVENTORY CONTROL原材料仓库/库存管理 D. REJECT MATERIAL HANDLING不合格物料处理 E. PLANNING/LOT # ASSIGNMENT计划/批次#任务 F. RAW MATERIAL DISPENSING原料配料 G. MANUFACTURING CONTROLS生产控制 H. LABEL CONTROL标签控制 I. PACKAGING/LABELING包装/贴签 FINISHED GOODS WAREHOUSE/SHIPPING成品仓库/运输 QC LABORATORY QC实验室 STABILITY PROGRAM 稳定性计划 MASTER AND BATCH PRODUCTION RECORDS批生产记录和主生产记录 BATCH RECORD REVIEW/LOT RELEASE批记录审核/批放行 DOCUMENT CONTROL文件控制 CHANGE CONTROL AND DEVIATIONS变更控制和偏差 TRAINING人员培训 AUDITS审计 CALIBRATION PROGRAM校验程序 PREVENTATIVE MAINTENANCE PROGRAM预防性维护程序 UTILITY SYSTEMS公用设施系统 VALIDATION PROGRAM验证程序 HOUSEKEEPING AND PEST CONTROL PROGRAMS后勤和害虫控制程序 GENERAL ISSUES CLOSING MEETING/WRAP-UP会议闭幕/总结 A. OVERVIEW Introductions and Overview介绍和概述 Scope of Audit审计的范围 CDA needed? Get approvals as required.是否需要CDA？要求时需经批准 Auditee presents overview of facility/operations. 受审人概述设施/操作 Request organizational chart (if not already received) 要求查看组织机构图（如果还没收到） Request facility floor plan (if not already received) 要求查看设施平面图（如果还没收到） Request copy of SOP/Procedure index 要求查看SOP复印件/操作规程索引 Quality Unit:质量部门 Is there an independent Quality Unit?是否具有独立的质量部门 Written Quality Unit SOP defining responsibility and procedures?质量部门的书面SOP是否定义了职责和操作规程 Quality Assurance Department? 质量保证部门？ Number of staff? 人员数量？ Quality Control Department? 质量控制部门？ Number of staff? 人员数量？ Consultants used? Training/Qualifications documented? 是否有咨询顾问？培训/资格认定是否进行记录？ B. INCOMING MATERIALS CONTROL进厂物料控制 Supplier and Supply Chain Management: 供应商和供应链管理 Supplier qualification/certification/re-qualification program? 供应商确认/证明/再确认程序？ Responsibility defined? 责任是否定义？ Written SOP in place? 书面SOP是否到位？ Audits of suppliers conducted? 是否进行了供应商的审计？ Verification of supplier’s test results on COA? 供应商提供的COA检验结果的确认？ List of approved suppliers? 经批准的供应商名单？ Receiving: 接收 Incoming materials/receiving SOP? 进厂物料/接收SOP Designated and identified area?指定和经标识的区域 Computerized system used? Validated?