准备FDA认证前检查Preparing for FDA Preapproval Inspections中英文对照.pptVIP

Richard Needham, RFL Associates * Document and Records Review文件和记录审查 Documents for which English Translations should be Provided 提供用于英文翻译的文件 Master Batch Record主要批次记录 Change Control SOP 变更控制SOP Including Document Change Control 包括文件变更控制 Validation Master Plan 确定总计划 Complaint Handling SOP 投诉处理SOP Deviation Management SOP 偏差管理SOP Richard Needham, RFL Associates * Document and Records Review (continued)文件和记录审查（续） Documents for which English Translations should be Provided 提供用于英文翻译的文件 Out-of-Specification SOP 规范之外的SOP Include A Flow Chart/Decision Tree 包括流程图/决策图标 Methods Validation SOP 方法验证SOP Stability Program SOP? 稳定性规划SOP Returns and Recalls SOP 退货和召回SOP Richard Needham, RFL Associates * Document and Records Review文件和记录审查 Documents for which English Translations should be Provided 提供用于英文翻译的文件 Product Development Report 产品开发报告 History of Product Development 产品开发的历史 How the Process was developed and optimized 如何推进这一进程的发展和优化 Pilot Scale to full scale batches 规模扩大的批次 Impurity Profile development 杂质分布图发展 Identification of critical process parameters 鉴定工艺的临界参数 Identification of critical product attributes 辨别临界产品的质量 Annual Product Reviews 年产量回顾 Richard Needham, RFL Associates * Document Staging Area文件临时存储区域 Have all of above documents available 上述文件都可用 Also have available:亦可用： Calibration Certificates (Instruments and Equipment) 校准证书（仪器设备） IQ/OQ/PQ records for instruments and equipment 仪器设备的IQ/OQ/PQ记录 Richard Needham, RFL Associates * Document Staging Area文件临时存储区域 Have Available 可用 Product Stability Data (updated) 产品稳定性数据（更新） Summarized data tables (from annual review)汇总数据表（从年度审查） Supporting test records支持的测试记录 Training SOPs and Records ＳＯＰ培训和记录 Make sure people on all shifts are trained 确保所有人的手段都是进过培训的 Have copies of training outlines or agendas (subject matter) 有培训大纲或议程的副本（主题） Have individual training files available 有个别可用的培训文件 Richard Needham, RFL Associates * Internal Audits and the FDA Insp