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Hi Vajra,
In my opinion,
Specificity, Matrix effect, Linearity (if linearity change, re-assess dilution integrity) and 3PA
3PA and dilution integrity
It depends on the reason why your batches were rejected. Can it be a sample processing issue? In any case, you should have investigated this.
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Edit: Original quotes restored. [Helmut]
In my opinion,
❝ 1. For the change in the instrument (for example from API3200 to
❝ API4000)
Specificity, Matrix effect, Linearity (if linearity change, re-assess dilution integrity) and 3PA
❝ 2. For the change in the regression model (for example linear to
❝ qudratic)
3PA and dilution integrity
❝ During the method validation i have generated data of 8 P&A batches.
❝ out of 8, 3 batches (40% of failure in the data generated) not meet
❝ the acceptance criteria as per the SOP.Can i say the method as accurate
❝ and precise.
It depends on the reason why your batches were rejected. Can it be a sample processing issue? In any case, you should have investigated this.
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Edit: Original quotes restored. [Helmut]
—
Regards, Geokad
Regards, Geokad
Complete thread:
- partial validation vajra 2008-10-08 17:04
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- partial validationGeokad 2008-10-09 16:03
Ing. Helmut Schütz