MHRA-OOS-OOT-Oct17+中英.pptxVIP

Out of Specification Out of Trend Investigations超标偏离趋势调查 ;How to use the Investigation Flowchart/如何使用调查流程图;Laboratory Analysis;化验室分析;Laboratory Analysis;化验室分析;OOS / OOT Result;OOS / OOT 结果;No Error found;未发现错误;Phase la Investigation;第Ia阶段调查;Phase la Investigation - Obvious Error;第Ia阶段调查---明显错误;Phase Ib Investigation;;Phase Ib Investigation - Definitions;第Ib阶段调查---定义;Phase Ib Investigation - Definitions;第Ib阶段调查---定义;Hypothesis/Investigative Testing – Is testing performed to help confirm or discount a possible root cause i.e what might have happened that can be tested:- for example it may include further testing regarding sample filtration, sonication /extraction; and potential equipment failures etc. Multiple hypothesis can be explored.;假设/调查性检测 – 所实施的检测是否有助于确认，或排除一个可能的根本原因，即，可能发生了哪些可以检出的什么事情：例如，可以包括进一步测试，关于样品过滤、超声、萃取，以及可能的仪器失败等。可以探索多个假设的可能性。;Phase Ib Investigation – Initial Investigation conducted by the analyst and supervisor using the Laboratory Investigation Checklist Contact Production/Contract Giver/QP/MAH as appropriate For microbiological analysis where possible once a suspect result has been identified ensure all items related to the test failure are retained such as other environmental plates, dilutions, ampoules/vials of product, temperature data, auto-pipettes, reagents – growth media. No implicated test environmental plates should be destroyed until the investigation has been completed. The Analyst and Supervisor investigation should be restricted to data / equipment / analysis review only On completion of the Analyst and Supervisor investigation re-measurement can start once the hypothesis plan is documented and is only to support the investigation testing. This initial hypothesis testing can include the original working stock solutions but should not include another preparation from the original sample (see: re-testing) ;第IB阶段调查---由化验员和主管采用化验室调查用的检查清单进行初步调查 适当时应联系生产部门、委托方、QP、MAH 对于微生物测试，如果可能，一旦认定结果可疑，应保证保留所有与检测失败相关的材料，例如其它的环境监控碟、稀释液、产品安瓿瓶/小瓶、