Test Method Validation Help - New titration test method, not defined in the USP
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.