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tarak_desai ☆ India, 2011-06-07 10:49 (5499 d 08:23 ago) Posting: # 7085 Views: 3,588 |
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Dear all, Can anyone give a referance of guidance which says that instrument are to be calibrated/traceable to national standards. Thanks Tarak |
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Ohlbe ★★★ France, 2011-06-07 12:25 (5499 d 06:47 ago) @ tarak_desai Posting: # 7086 Views: 3,110 |
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— Regards Ohlbe |
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tarak_desai ☆ India, 2011-06-07 13:21 (5499 d 05:51 ago) @ Ohlbe Posting: # 7088 Views: 3,034 |
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Dear Ohlbe, Thanks for prompt reply. In addition, i require referance guidance for instruments like BP apparatus, thermometer (i.e. instruments using at investigator site)are to be calibrated/treceable to national standard. With Regards, Tarak |
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Ohlbe ★★★ France, 2011-06-07 14:12 (5499 d 05:00 ago) @ tarak_desai Posting: # 7089 Views: 3,057 |
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Dear Tarak, I can't find any specific requirement for it in ICH GCP. For a BE trial I would consider it sufficient to follow the recommendations for maintenance/calibration/certification of the manufacturer of whatever device you are using. In a Phase II or III study, if a device is used to generate pivotal data (e.g. BP apparatus in a study on a anti-hypertensive drug), it would be much more important to be able to demonstrate that the device works properly. § 2.13 of ICH GCP is wide and vague enough to be used as a reference for just about anything in clinical trials: Systems with procedures that assure the quality of every aspect of the trial should be implemented. Regards Ohlbe — Regards Ohlbe |
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swapnil.kuche ★ 2011-06-10 13:30 (5496 d 05:42 ago) @ tarak_desai Posting: # 7102 Views: 2,988 |
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Dear Tarak, Whatever the equipment you are using during BA/BE or clinical trial which produce data used for interpretation has to be calibrated brfore it's use. Equipment not required to be calibrated are vortex shaker in bioanalytical pippettes used during plasma seperation (if quantity to be seperated isnot specified in the protocol. Tracebility of calibration should be confirmed by checking calibration status of equiment used for calibration of equipment under consideration. And ideally all tracebility certficates should be available with calibration records. Regards, Swapnil D. Kuche |
Ing. Helmut Schütz