GLP--良好实验室规范.ppt

GLP(良好实验室规范) 5、REFERENCE MATERIALS- 3 标准物质 Care must be taken for the certified reference materials to ensure that they are packaged, stored and handled properly to prevent deterioration. Certificate and records of receipt and use shall be maintained. 有证基准物必须妥善包装、存放和处置，以防止变质，应保存收货和使用记录及证书，计算时应按证书标明的含量。 The laboratory shall assign suitable staff as monitor(s) for certified reference materials. Their duties shall include ordering or assisting in the ordering of new reference materials, checking calculations of assays, refilling empty working supply containers, keeping lists of laboratory-available certified reference materials up to date. 指定合适人员监控有证基准物，其职责包括订购或协助订购的基准物，检查计算，向专用的空容器中补充基准物溶液，和更新实验室有证基准物清单。 GLP(良好实验室规范) 5、REFERENCE MATERIALS- 4 标准物质 It is preferable to keep sign-in and sign-out log books. Each analyst using a certified reference material shall register the name of the reference material, the date and time it is taken and returned, and his or her initials. 一个值得提倡的做法是设置一签收和签发记录本。每个使用有证基准物的分析员均登记基准物名称，取用和返还的日期和时间，以及使用者小签。 Analysts shall be instructed for the care of certified reference materials and following the procedures for handling them. 分析员必须了解并按有证基准物的处置程序使用和处置有证基准物。 GLP(良好实验室规范) 5、REFERENCE MATERIALS- 5 标准物质 Working Reference Materials 工作标准（二次标准） A working reference material can usually be defined as a substance other than a certified reference material that is standardized with certified reference material and used as a reference material in day-to-day analyses. 工作标准（二次标准）通常是采用有证基准物进行标定用作日常分析工作的标准。 A working reference material shall be assayed by the best method available, and the results shall be entered in a notebook for that purpose. Entries shall include the analyst’s name, date of analysis, source, lot number, all raw data, charts, and calculations. 工作标准（二次标准）应用最好的方法标定，结果记入专用记录。记录内容包括分析员姓名、分析日期、基准的来源和批号，所有原始数据、图表和计算。 GLP(良好实验室规范) 5、REFERENCE MATERIALS- 6 标准物质 A working reference material shall be handled in essentially the same manner as a