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pmgjoshi ☆ India, 2009-03-30 13:12 (6302 d 11:05 ago) Posting: # 3413 Views: 4,059 |
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Dear all, It's regarding the During Study Validation Report. In that we have to take all the CC and QCs for global calculations (calculating Average, SD, RSD etc.for all the CC and QCs acquired during Subject sample analysis). Case 1. Suppose one of my batches failed for, QCs not meeting the acceptance criteria i.e. 7 out of 12 QCs failed. (I have put all the QCs value in the excel spreadsheet) Should the failing QCs be Asterisked (bear '*' and gets excluded from the calculations) and rest of the QCs be considered for Global calulations? Or the failing batch should not be considered? Case 2. One of my batches meets the acceptance criteria i.e. 3 out of 12 QCs failed. So, should the failing QCs be asterisked and not considered for calculations? Best regards, Prashant |
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Ohlbe ★★★ France, 2009-04-03 15:17 (6298 d 09:00 ago) @ pmgjoshi Posting: # 3457 Views: 3,428 |
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Dear Prashant, ❝ Case 1. Suppose one of my batches failed for, QCs not meeting the ❝ acceptance criteria i.e. 7 out of 12 QCs failed. In that case the results of this batch, including the QC results, do not need to be reported. Just keep the raw data in your archives, in case you are unlucky and get an inspection  ❝ Case 2. One of my batches meets the acceptance criteria i.e. 3 out of 12 ❝ QCs failed. So, should the failing QCs be asterisked and not considered ❝ for calculations? Assessors will appreciate to have failing values identified in the report (with an asterisk or any other sign). But you should keep these results in the calculations. No guideline on this topic - but have a look at Regards Ohlbe Edit: Link correct for new FDA's site structure. [Helmut] |
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pmgjoshi ☆ India, 2009-04-05 18:13 (6296 d 06:04 ago) @ Ohlbe Posting: # 3473 Views: 3,253 |
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Ing. Helmut Schütz