In your PPT there is no clarity about calculation of SD. Whether it will calculated on five results of five no. i. e. no. of preparations. Your SD value is not exactly matching with your data.
In our company we perform retesting 1st analyst one time second analyst 2 time and third analyst 3 time .. can you refer any guidelines related to this ...
Thank you for very valuable information. Can you suggest how way forward will be decided by QA if 95% confidence limit is not achievable, pls extend your support in this regard for more learning pls
Suppose if it is assay test and 95% CI not meeting , in that case Quality team need to assess min, max & average results of 👉🏻UOD test, 👉🏻Dissolution test, 👉🏻Previous trend of Assay results . 👉🏻Blend stage results of assays and BU test for the impacted batch. One thing you have to keep in mind if 95% CI is not meeting the criteria it doest mean that your product is failing, It simply indicates that there is a variability in results however results are well within the specification limit. Same results can be considered for reporting. And further you can monitor upcoming batches assay as well .
Thanks Nice information , RS Calculation found wrong due to √n Value and plz explain if any result found out of Calulated 95%CL what is further procesd
Firstly welcome sir and congrats for having eagle eye. Typo error for square root n it should be 1.732 instead of 1.372, but calculation done using 1.732 only..👍
And answer to second question is.. if 95% failing for any unit then we need to assess trend data. Based on that decision can be taken on batch disposition. If you have any other information,please share all will be benefited.
We got 3 or 5 preparation results, 95 % confidence limit is met.finally what is the final result of the oos batch after getting 3 or 5 preparation results
