Bioequivalence and Bioavailability Forum • partial validation

vajra
●

2008-10-08 19:04
(6470 d 16:22 ago)

Posting: # 2493
Views: 3,535

partial validation [Bioanalytics]

Hi group members,

I want to the know the parameters to be established during the partial validation.

1. For the change in the instrument (for example from API3200 to API4000)
2. For the change in the regression model (for example linear to qudratic)

In addition to the above one more case i would like to present:

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.

regards,
Vajra :-D

Geokad
☆

Canada,
2008-10-09 18:03
(6469 d 17:23 ago)

@ vajra
Posting: # 2498
Views: 2,826

partial validation

Post reply

Hi Vajra,

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]

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Regards, Geokad