GoodDocumentationGuidelines良好文件准则.ppt

分析程序 Analytical Procedures Analytical procedures provide direction to an operator on how to perform a given analytical test. The following sections will typically be included in the analytical procedure: - Purpose : Test information :Product information - Safety information, if applicable - Materials and equipment - Procedure, as applicable :System suitability :Preparation of solutions and reagents :Preparation of standards and samples :Instrument parameters :Calculations and reporting - Review and approval with approval dates - Revision history 分析程序为操作员提供了如何进行特定分析测试的指导。以下部分将通常包含在分析程序中： 1、目的：检测信息、产品信息；2、安全信息（如适用）；3、材料和设备；4、程序，如适用：系统适用性、溶液和试剂的制备、标准品和样品制备、仪器参数、计算及报告；5、审核批准日期；6、修订记录。 培训文件 Training Documentation Personnel should be trained to perform their assigned tasks. The training should be documented, and the training records should be retained and kept readily accessible. In general, training documentation should include: -Training description including name of training, version, and mode (self-training or instructor led) - Completion date - Information on the trainer, as applicable 培训人员执行指定任务。培训应记录在案，培训记录应保留并随时可查阅。在一般情况下，培训文件应包括： 1、培训描述，包括培训名称、版本和模式（自我训练或指导教师） 2、完成日期 3、关于培训师的信息，如适用 保留文件 RETENTION OF DOCUMENTS An adequate policy for record retention and archiving should be established for the above records. The required length of time depends on the regulatory requirements or company procedures; however, it should be at least 1 year after the batch expiration date. 应为上述记录制定适当的记录保存和归档政策。所需的时间长短取决于监管要求或公司程序;但是，批次到期后至少1年。 THANKS FOR YOUR ATTENTION !! AQUARELLE POWERPOINT TEMPLATE Good Documentation Guidelines --良好文件指南 安凯浩 2017.10.27 PPT模板：/moban/ PPT素材：/sucai/ PPT背景：/beijing/ PPT图表：/tubiao/ PPT下载：/xiazai/ PPT教程： /powerpoint/ 资料下载：/ziliao/ 范文下载：/fanwen/ 试卷下载：/shiti/ 教案下载：/jiaoan/