Analytical Method Validation for Pharmaceuticals

[KarenJ]

Good morning,

I have a question about method terminology. Different levels of validation are often done for methods used for pharmaceutical compounds at different stages of development. For example, a method used to test phase I CT materials may have limited repeatability studies but a method releasing commercial product should include repeatability, intermediate precision, and reproducibility assessment. Also, methods used for different purposes require different levels of validation. For example an impurities limit test may only require specificity and detection limit studies but a potency release method may require the full battery of ICH tests. Although there are all of these different levels of validation, I have never seen a consistent terminology that distinguished between methods with different degress of validation. I often hear people say that their method is "validated", but without additional information, it is not always clear what this means. Does anyone have a naming convention that they use that works well for making these distinctions?

Thanks for your suggestions.

KarenJ

[David Blais]

We have an SOP for validation of analytical methods that outlines what parameters need to be validated at each stage of the development process. So when we say a method is validated for Phase I, people who are familiar with the SOP know what portions have been completed and what portions have not. If they are not familiar, a simple read-through of the SOP clarifies it for them.

I'm not certain there is an "industry standard" for this type of naming convention, but this works for us. Hope this helps.

Regards,
-Dave