J
I was hoping for some advice concerning test method validation.
We undertake a series of QC tests (on raw materials, intermediates and final device) on a product currently in development and I am struggling as to how I can validate a number of these tests. Some are common such as pH, dimensions, FT-IR analysis whilst other are fairly product specific.
My question relates to how to go about validating some of these test methods. How would you validate a pH test. Do you approach it from a material/product point of view or the equipment perspective (I know how to calibrate a pH meter/probe but is this sufficient?) Another thing I am having difficulty with is how to validate the FT-IR analysis of a compound. In this instance linearity isn't an issue.
Any advice with this would be appreciated.
We undertake a series of QC tests (on raw materials, intermediates and final device) on a product currently in development and I am struggling as to how I can validate a number of these tests. Some are common such as pH, dimensions, FT-IR analysis whilst other are fairly product specific.
My question relates to how to go about validating some of these test methods. How would you validate a pH test. Do you approach it from a material/product point of view or the equipment perspective (I know how to calibrate a pH meter/probe but is this sufficient?) Another thing I am having difficulty with is how to validate the FT-IR analysis of a compound. In this instance linearity isn't an issue.
Any advice with this would be appreciated.