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Shastris ☆ 2010-04-01 21:42 (5929 d 13:32 ago) Posting: # 4999 Views: 3,174 |
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Dear all, Sometimes there are instances where in passed data is rejected. E.g due to instrument issues or due to visible variation in response (analyte and/or Internal standard areas). Is this acceptable and what is the required documentation for this? |
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Ohlbe ★★★ France, 2010-04-02 13:55 (5928 d 21:19 ago) @ Shastris Posting: # 5000 Views: 2,583 |
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Dear Shastris, It is acceptable if you indeed have a real, objective and well documented reason. Of course it is better to have it prospectively defined in an SOP, but you cannot think of every possible situation in advance and write them in an SOP, and you need to use your scientific judgement too if you think there is a problem with the run. The results of the failed runs do not need to be reported, but you should list the rejected runs in the report, with the reason for the rejection. Keep all documentation relating to the rejected runs in your archives with the trial documentation, and particularly those documents showing what the problem was, the decision taken (when and by whom), and any possible corrective or preventative action you may have taken. Regards Ohlbe Post number 5000...  to all! [Helmut] |
Ing. Helmut Schütz