Bioequivalence and Bioavailability Forum

Hi Prabhakaran,

please see the Forum’s Policy!

❝ i want to know the acceptance and rejection criteria for an analytical batch..

Do you see the link Guidelines above? Please do your own homework first.

❝ all the regulatory authorities from different countries will have different criteria

On the contrary I would say their criteria are remarkably similar.

❝ but i want to know the common criteria which is acceptable by all.???

What do you expect from fulfilling just the intersection?

You will not be fully compliant with any of them. So what’s your point?
If you want to submit your study to three authorities you have to be compliant with all of them.

Example: For the FDA you have to document recovery and for the EMA carry-over. If you want to use a method acceptable for both you should show recovery and carry-over in the validation. Maybe you leave out the irrelevant sections in the submission in order not to confuse check-list assessors. Furthermore, ISR is not mentioned in FDA’s guidance – nevertheless, I bet that they expect you to show it.