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auditor ★ India, 2011-06-29 10:21 (5089 d 18:04 ago) Posting: # 7181 Views: 3,230 |
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Dear All, Kindly comment on the followings: One of the analyte is validation on waters system and during the subject samples analysis due to instrument failure, the study is divided into two systems i.e. Waters and API. Half of the subject of the study is analyzed on waters systems and half of the subjects are analyzed on API system. however the change of the instrument is supported by onely one P&A batch. My understanding is to perofm atlest three P&A, matrix effect and selectivity/ sensitivity on other (API) instrument to justify the conduction of study. Kindy suggest the correct practice and give if there is any reference on the above mentioned case. Regards, Auditor. |
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Ohlbe ★★★ France, 2011-06-29 12:06 (5089 d 16:18 ago) @ auditor Posting: # 7186 Views: 2,551 |
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Dear Auditor, ❝ My understanding is to perform at least three P&A, matrix effect and selectivity/ sensitivity on other (API) instrument to justify the conduction of study. Agreed. Basically I would repeat the whole validation except stability experiments (and recovery, if you have it as part of your validation). ❝ Kindly suggest the correct practice and give if there is any reference on the above mentioned case. No reference that I know of. The FDA guidance is extremely vague on partial validation (just says it can be anything from a single run for precision and accuracy to an almost full validation). But you should be able to justify scientifically what experiments need, and do not need, to be repeated. Matrix effects, selectivity and LLOQ do depend on the instrument you are using. Regards Ohlbe — Regards Ohlbe |
Ing. Helmut Schütz