partial validation [Bioanalytics]

posted by Geokad – Canada, 2008-10-09 18:03 (6471 d 11:18 ago) – Posting: # 2498
Views: 2,838

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.

--
Edit: Original quotes restored. [Helmut]
—
Regards, Geokad

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