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Ramesh ☆ India, 2008-01-04 07:12 (6748 d 15:46 ago) Posting: # 1465 Views: 5,067 |
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dear group members, case:1 Is it necessary to have calibration of the instrument/equipments used for the quantitative purpose in case of bioanalysis. for example if in am using the solvent dispenser for the addtion of the extraction solvent in to the samples is it necessary that the solvent dispenser is need to be calibrated. if yes can u provide me reference for th same. with regards, Ramesh — with regards, Ramesh |
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Ohlbe ★★★ France, 2008-01-04 11:29 (6748 d 11:30 ago) @ Ramesh Posting: # 1468 Views: 4,216 |
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Dear Ramesh, The OECD GLP guideline states (§4.2) that Apparatus used in a study should be periodically inspected, cleaned, maintained, and calibrated according to Standard Operating Procedures. Records of these activities should be maintained. Calibration should, where appropriate, be traceable to national or international standards of measurement. There is no specific guideline giving a minimum periodicity. This will be user-defined, based on manufacturer recommendations, use of the equipment, and previous experience. In the specific case you are giving (solvent dispenser) a lack of precision or accuracy in the volume delivered would have no impact if you have an internal standard. But checking the pipette used to distribute the plasma samples or the IS would be much more critical. GLP section 4.2 applies to any kind of equipment used in your study, from the freezer used to store your plasma samples to your HPLC system. Regards Ohlbe |
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Ramesh ☆ India, 2008-01-08 12:09 (6744 d 10:49 ago) @ Ohlbe Posting: # 1478 Views: 4,034 |
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Dear Ohlbe, thanks for your reply, but in am not getting the extact requirment of mine. as your saying as per OECD GLP Sec 4.2 calibration is required and also ur saying that if internal stnadard is usedthere will be no impact. so i am confusion, whether the calibration of the solvent dispenser is required or not when used in the quantitative analysis. please correct me if i am wrong. with regards, Ramesh.V — with regards, Ramesh |
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Ohlbe ★★★ France, 2008-01-08 13:13 (6744 d 09:45 ago) @ Ramesh Posting: # 1479 Views: 4,151 |
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Dear Ramesh, Personally I would not bother too much about solvent dispensers. You may get a question from an auditor or an inspector, be ready to explain why it is not relevant. The question will then be, whether the auditor or inspector understand what he does or not, and you can never know in advance  . On the other hand, there are so many sources of variability in a method that having control over one can't hurt you. If the solvent volume is dispensed with a correct repeatability, you will limit the variability of your IS response, which is another source of discussions ! So to summarise: I would consider checking the solvent dispenser as not vital, but still of use. Regards Ohlbe |
Ing. Helmut Schütz