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RegisterWhat’s the problem? [Bioanalytics]
Hi auditor,
I agree with the views of HS and Ohlbe expressed here and would like to point out that in any method development you have a specification of how much the technician should weigh (like 0.1150 g or sumfin like that). You are dealing with a situation where the actually weighed amount is a little higher than it has been previously during the development but it could still be weighed correctly according to the method description. That in itself opens another can of worms; if you wish to avoid the situation of concern then you somehow need to ascertain that the study analyst never uses an amount literally exceeding the largest amount used during method development/validation ("weigh not more than 0.1142 grams") which one can argue imposes a change to the method and that's not what you wish to do at that stage.
I totally see your concern, but I think this case is best solved by practical thinking.
❝ Example:
- In validation you weighed in 20.1 mg and in the study 19.9 mg.
❝ Deviation –1%: no problem.
❝
- In validation you weighed in 19.9 mg and in the study 20.1 mg.
❝ Deviation +1%: problem. Why?
I agree with the views of HS and Ohlbe expressed here and would like to point out that in any method development you have a specification of how much the technician should weigh (like 0.1150 g or sumfin like that). You are dealing with a situation where the actually weighed amount is a little higher than it has been previously during the development but it could still be weighed correctly according to the method description. That in itself opens another can of worms; if you wish to avoid the situation of concern then you somehow need to ascertain that the study analyst never uses an amount literally exceeding the largest amount used during method development/validation ("weigh not more than 0.1142 grams") which one can argue imposes a change to the method and that's not what you wish to do at that stage.
I totally see your concern, but I think this case is best solved by practical thinking.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Extrapolation of Calibration Curve auditor 2012-02-10 06:45
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Exact weight Ohlbe 2012-02-10 12:05
- Exact weight auditor 2012-02-10 15:54
- Exact weight: impossible Helmut 2012-02-10 17:33
- Exact weight Ohlbe 2012-02-10 18:10
- Exact weight Helmut 2012-02-10 19:15
- Exact weight auditor 2012-02-11 06:49
- What’s the problem? Helmut 2012-02-11 12:59
- What’s the problem?ElMaestro 2012-02-11 20:20
- What’s the problem? auditor 2012-02-13 05:35
- Adjusted dilution? Helmut 2012-02-13 13:29
- What’s the problem? Aceto81 2012-02-16 10:50
- What’s the problem? auditor 2012-02-16 12:23
- ±5%? Helmut 2012-02-16 13:24
- weight pharmino 2012-02-17 21:24
- API/formulation Helmut 2012-02-18 13:34
- weight pharmino 2012-02-17 21:24
- What’s the problem? Helmut 2012-02-11 12:59
- Exact weight auditor 2012-02-11 06:49
- Exact weight Helmut 2012-02-10 19:15
- Exact weight auditor 2012-02-10 15:54
- Exact weight Ohlbe 2012-02-10 12:05
Ing. Helmut Schütz