partial validation [Bioanalytics]

posted by vajra – 2008-10-08 19:04 (6466 d 18:56 ago) – Posting: # 2493
Views: 3,520

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

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