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Compliance ★ India, 2012-02-29 06:36 (4840 d 03:52 ago) Posting: # 8183 Views: 3,209 |
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Dear All, Is it suggested to perform FT stability also if the sample storage is also proven at -20 storage additionally by performing long term stability in matrix for 15 to 30 days duration? The FT experiment is already proven for -70 in which the entire validation samples were stored. For more clarity, the stability estimation done on -20 to handle some temperature variation if any occurs while storing samples at -70 condition. So if the stability is proven at -20 then the entire storage condition -70 to -20 is covered. kindly give your suggestion. Regards, Compliance |
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Ohlbe ★★★ France, 2012-02-29 19:44 (4839 d 14:43 ago) @ Compliance Posting: # 8192 Views: 2,652 |
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Dear Compliance, As far as I know, studying stability for some time at -20°C in addition to -70°C, is not required by any guideline if the samples will only be stored at -70°C. That's really playing it safe, and you could very well decide to do it only if you indeed have freezer problems. It would only take a few days and would not delay the work any further. If you store the QC samples in the same freezer as the study samples, you could very easily demonstrate that the integrity of the study samples was not affected at any time. In my opinion doing freeze/thaw stability at -20°C in addition to -70°C is not required in such a case. Regards Ohlbe — Regards Ohlbe |
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Compliance ★ India, 2012-03-01 08:36 (4839 d 01:51 ago) @ Ohlbe Posting: # 8194 Views: 2,652 |
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Thank you very much for your concern. regards, Compliance |
Ing. Helmut Schütz