Chromatography Forum

On the Quality Control Specification & Method that we have. What we used on our assay, Related Substance and dissolution is our validated method. But now, our drug product becomes official on the USP. Am I right? Since our drug product becomes official on the USP, we need to change the methods and specifications that we have but instead of validation, we just need to perform verification of the USP methods? Thanks.

Yes and No.

If you feel your method works better than the USP method then official regulators (FDA for example) won't mind you using that method so long as you have evidence to it's ability to perform better, which you have done if it's been validated.

However if you find the newly added USP method works just as well or better, then yes, all that is needed is a verification. Though, to be honest, performing the standard validation work (accuracy linearity and intermediate precision and specificity, the big 4) can be done practical wise in a week, maybe two, that you may as well validate it within your laboratory. Less questions, and if it is investigated, you know you're fully covered.

Yes and No.

If you feel your method works better than the USP method then official regulators (FDA for example) won't mind you using that method so long as you have evidence to it's ability to perform better, which you have done if it's been validated.

However if you find the newly added USP method works just as well or better, then yes, all that is needed is a verification. Though, to be honest, performing the standard validation work (accuracy linearity and intermediate precision and specificity, the big 4) can be done practical wise in a week, maybe two, that you may as well validate it within your laboratory. Less questions, and if it is investigated, you know you're fully covered.

On our validated method, I have no question about it. But as per USP, the specification changes and also the impurity concerned was mentioned which is not covered on our validated method. On that case, would it mean that we still need to perform verification of the USP method and apply whatever specs they mentioned instead? Thanks.

That's really a question that should be addressed in your company's SOPs.

If you are labelling your product as "USP grade" or "per USP", or something similar that mentions USP, then yes, you do have to verify that your method gives reults equivalent to the USP method. Otherwise, my understanding is that your specs are whatever your specs are and that your analytical method has been validated.

That's really a question that should be addressed in your company's SOPs.

If you are labelling your product as "USP grade" or "per USP", or something similar that mentions USP, then yes, you do have to verify that your method gives reults equivalent to the USP method. Otherwise, my understanding is that your specs are whatever your specs are and that your analytical method has been validated.

Thanks a lot

That's really a question that should be addressed in your company's SOPs.

If you are labelling your product as "USP grade" or "per USP", or something similar that mentions USP, then yes, you do have to verify that your method gives reults equivalent to the USP method. Otherwise, my understanding is that your specs are whatever your specs are and that your analytical method has been validated.

Thanks a lot

As member of the Product DEVELOPMENT TEAM, it is our responsibility to perform method validations/verifications of the newly formulated product to comply on the requirements to be submitted for regulating body such as FDA. The FDA will then assess whether we could REGISTER our drug product for MARKETING purpose.
Question:
If in case the drug is approved already for registration, would it still be the Development Department responsibility to check time to time whether the validation/verified method needs to be updated. Let say the DRUG PRODUCT becomes official on USP?
Or should it be the Finish Product Department would be reliable on updating validation/verification if it is needed since they are the one already dealing with the registered drug product using the previously FDA APPROVED validated/verified method of the Development?

You need to talk to the lawyers in your Regulator Affairs Department.

That said, my interpretation would be what I stated earlier: if your labeling or registration claims "USP" in any way, then your analytics must be equivalent to what the USP monograph states. If you don't, then the product is what the product is, and a validated method that passed muster last week will still be OK next week regardless of what the USP does. Note that I am not in any way, shape, or form an expert on regulatory affairs, so take that statement for what it's worth (i.e. $0.02).