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IK ☆ India, 2010-04-12 13:31 (5918 d 03:25 ago) Posting: # 5084 Views: 5,673 |
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Dear Members, Please suggest me on the following: During subject sample analysis, in a batch individual repeats (dilution integrity samples) were also analysed along with DI QCs (dilution integrity quality control samples). In that batch DI QCs failed to meet specifications. Now, should I reject the batch? (or) Should I code only the DI samples and repeat again? Please do needful on the same. Thanks & Regards IK |
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Helmut ★★★   Vienna, Austria, 2010-04-12 16:36 (5918 d 00:20 ago) @ IK Posting: # 5089 Views: 4,849 |
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Dear IK! ❝ During subject sample analysis, in a batch individual repeats (dilution ❝ integrity samples) were also analysed along with DI QCs (dilution ❝ integrity quality control samples). In that batch DI QCs failed to meet ❝ specifications. ❝ ❝ Now, should I reject the batch? (or) Should I code only the DI samples and ❝ repeat again? Interesting approach. IMHO once you have validated the method for dilution integrity, there is no need to run 'DI QCs' (to be honest, never heard this term before). Don't you have an SOP for such a situation? I would say:
P.S.: Consider signing you posts with something more close to a name than only initials. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Ohlbe ★★★ France, 2010-04-12 18:35 (5917 d 22:22 ago) @ Helmut Posting: # 5096 Views: 4,852 |
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Dear IK and Helmut, ❝ IMHO once you have validated the method for dilution integrity, there is ❝ no need to run 'DI QCs' (to be honest, never heard this term before). I've seen it before, though it is indeed not mandatory IMHO. ❝ Don't you have an SOP for such a situation? I would say: ❝ ❝ I agree. Regards Ohlbe |
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Geokad ☆ Canada, 2010-04-12 22:38 (5917 d 18:18 ago) @ Helmut Posting: # 5097 Views: 4,854 |
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Dear IK and HS, ❝ Interesting approach. IMHO once you have validated the method for dilution ❝ integrity, there is no need to run 'DI QCs' (to be honest, never heard this ❝ term before). Don't you have an SOP for such a situation? I would say: ❝ In the validation, you demonstrate that by diluting a sample for example twice the ULQ concentration, the calculated concentration is not compromised. In other words, the ability to dilute a certain concentration is validated using one dilution factor (5 or 10 folds). However, during sample analysis, by diluting High QCs with the same dilution factor that is applied to subject samples, you are validating the dilution factor you are applying on that day by the same analyst who’s diluting both QCs and subject samples. ❝ I agree — Regards, Geokad |
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IK ☆ India, 2010-04-13 06:59 (5917 d 09:58 ago) @ Geokad Posting: # 5098 Views: 4,784 |
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Dear All, Thanks a ton for your valuable comments. Best Regards IK (Indrakumar) |
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vajra123 ☆ India, 2010-04-21 11:47 (5909 d 05:10 ago) @ Helmut Posting: # 5177 Views: 4,743 |
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Hi HS, Regarding this i have one doubt. As you said, ❝ ❝ You mean to say that the dilution quality controls are not the part(are not consider for) of the batch acceptance. regards, — Vajra |
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Geokad ☆ Canada, 2010-04-21 18:05 (5908 d 22:52 ago) @ vajra123 Posting: # 5179 Views: 4,779 |
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Hi Vajra123, ❝ You mean to say that the dilution quality controls are not the part(are ❝ not consider for) of the batch acceptance. Right. These QCs are not part of the batch acceptance criteria. They are only used to evaluate the dilution. — Regards, Geokad |
Ing. Helmut Schütz