可删除复制PSCCV清洁验证.ppt

Execute the Study执行试验 Collect and maintain all raw data收集和保留所有原始数据 Follow good documentation practices遵循GDP Promptly investigate and resolve any deviations快速调查和解决任何偏差 Cleaning Validation Report清洁验证报告 Collect the raw data收集原始数据 Tabulate the raw data制表整理原始数据 Analyze the data分析数据 Verify that all runs meet all acceptance criteria 证实所有次数符合所有接收标准 Cleaning Validation Report清洁验证报告 Prepare the validation report presenting the data and conclusions准备验证报告，报告展示数据和结论 Use a standard format使用标准格式 Attach copies of raw data or printouts附上原始数据或打印件的复制件 Discuss and resolve any “circumstances affecting the quality or integrity of the data”讨论和解决任何“影响质量或数据完整性的情况” Cleaning Validation Report清洁验证报告 The report or any amendment to the report are reviewed and approved by报告或任何报告增补由以下部门审核和批准 Operations生产运营 Other key departments其它关键部门 Quality Assurance质量保证 The approved report or any amendment is a controlled document批准的报告或任何增补是控制文件 Cleaning Validation Report清洁验证报告 Keep the original approved document and associated raw data in document control or archives保持原先批准的文件和相关原始数据在文件控制或文件档案中 The cleaning validation report is the written proof that the cleaning process is validated.清洁验证报告是清洁流程已验证的书面证明 Update the cleaning validation master plan更新清洁验证主计划 Cleaning Process Revalidation清洁流程再验证 Consider during the change control process if the proposed change requires revalidation of the cleaning process在变更控制时考虑，是否提议的变更需要清洁流程的再验证 Consider during the periodic product review if the cleaning process requires revalidation在周期性产品审核时考虑，是否需要再验证 We Cleaned it! What Happened? 我们已清洁它了！发生了什么？ We Cleaned it! What Happened? 我们已清洁它了！发生了什么？ We Cleaned it! What Happened? 我们已清洁它了！发生了什么？ A Surface is Just a Surface...表面仅仅是表面… Understand the characteristics and chemistry of the surfaces of your equipment and the materials in your production and cleaning processes.理解（生产和清洁工艺中）您的设备表面和物品的特性和化学性质 Surfaces Age表面老化 Stainless steel requires periodic passivation不锈钢要求周期性钝化 Stainless steel may require polishing不锈钢要求抛光 Plastic