Revalidation of method

[michaelcarolus]

Hi everyone

We have changed our API supplier and was wondering what tests are required for revalidqation. At the moment I'm thinking of only repeating the specificity and method precision. Is this sufficient for revalidation of an HPLC assay method?

Thanking you in advance.
Mike

[tom jupille]

I'm a bit confused on the question. Why would you have to revalidate the assay because you have changed supplier? Unless I'm missing something, wouldn't your validated assay be applicable to API purity from any supplier?

[DR]

I wouldn't revalidate as a knee-jerk reaction, but I would inquire as to the nature of the synthesis route and impurity profile of the new supplier's product. If the impurity profile is not what you're used to, you will need to confirm that you can see any new stuff.

[ntruong]

I totally concur with Tom and Dr. Each supplier does have its own imputiry profile. You don't need to revalidate your method, but you do need to put at least a batch of your finished product manufacturing with new API supplier product on stability program.

[michaelcarolus]

Hi

Thanks for your response. I will compare the route of synthesis of the new API against the old API. If they are the same then I won't revalidate the method. If there are differences I will only do the specificity to ensure that my method is still stability indicating.

Thanks again.
Mike