I am relatively new to the pharmaceutical industry. Our lab is in the midst of developing a new titration test method, not defined in the USP. What kind of information should we include in the test method validation protocol/report? We have currently set up the testing to look at 3 different concentrations across a typical range, using 2 operators and 3 trials of each test. I am very familiar with Gage R&R studies, but the requirements on this type of test method validation seem less defined. Further, I am limited in resources to Excel. I used to work for a company that used Minitab. Those were the days! Any help anyone has is so much appreciated. Worksheets, tables, references, suggestions, guidance...I appreciate it all.

Thanks,
Sarah

Anyone here familiar with titration tests?

A Typical Method Validation in pharmaceutical industry includes:

1. Accuracy studies - (generally done when extraction or recovery is an issue). This may be required if your analyte is extracted into titration medium

2. Linearity - to make sure that range you wish to operate your test has a linear response.

3. Repeatability and Reproducibility - Also covers intermediate precision - generally done repeated by operators. - Your GageR &R should cover this requirement.

4. Limit of Quantitation/Detection - Generally done for chromatographic methods. - this is basically done to ensure that your method has a strong response (compared to noise) at low levels of analyte.

HTH

-CMT