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Loky do ★ Egypt, 2024-11-21 13:04 (60 d 15:56 ago) Posting: # 24285 Views: 1,259 |
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Hello dears, I am seeking advice on the best approach to address an Incurred Sample Reanalysis (ISR) trend failure in a bioanalytical study conducted over two years ago. At the time, we adhered to EMA guidelines, which did not require a detailed investigation of ISR trend failures. The ISR trend failure occurred in Period 2 for 6 out of 16 volunteers in this two-period study. The study was completed, submitted to various regulatory authorities, and accepted; subsequently, the study samples were disposed of. Recently, a new regulatory authority requested an investigation into this ISR trend failure in alignment with the updated M10 Bioanalytical Method Validation guidelines. They also requested sensitivity testing excluding the affected volunteers, and the study passed under these conditions. We have initiated the investigation but would appreciate guidance on the recommended steps and actions to address this situation effectively. Thanks in advance |
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qualityassurance ★ 2024-11-21 14:53 (60 d 14:07 ago) @ Loky do Posting: # 24287 Views: 1,071 |
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Hello Loky do, ❝ We have initiated the investigation but would appreciate guidance on the recommended steps and actions to address this situation effectively. In your response you can refer to the SOP and guidelines effective at that time. Anyways, documented investigation can be done and submitted by saying that the failure may be because of so and so reason or reason of failure is unknown. Regards, QA |
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Loky do ★ Egypt, 2024-11-22 13:16 (59 d 15:45 ago) @ qualityassurance Posting: # 24290 Views: 1,003 |
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Hello QA, In addition to the investigation, it is essential to undertake a robust corrective action, such as a confirmatory or partial re-study involving a sufficient number of volunteers. Will this help validate the effectiveness and reliability of the method for the reviewer? If so, is there any reference or previously published data supporting this action? Thanks alot |
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dshah ★★ India, 2024-11-27 13:46 (54 d 15:15 ago) @ Loky do Posting: # 24300 Views: 837 |
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Hi Loky do! I have a small doubt with your investigation. As you have already discarded the samples, how is the investigation possible with that sample/study of ISR. The best you can refer is as suggested by QA- to refer SOP at that time. Divyen |
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qualityassurance ★ 2024-11-27 15:27 (54 d 13:33 ago) @ Loky do Posting: # 24303 Views: 840 |
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Hello Loky do, In addition to my response above, you should present updated SOP (in line with ICH M10) as a part of your CAPA. To summersise, to the best of my knowledge follow below steps: - Refer SOP/guideline effective at that time - Try to have documented investigation - Provide evidence of reproducibility of analytical method - Prove that there is no impact on final BE outcome because of failure of ISR samples - Update your SOP as per new guideline I hope it will work. Regards, QA |
Ing. Helmut Schütz