Some of the regulatory bodies of unregulated sector are asking full validation data of USP official monograph analytical method. is this the requirment??? as i understand official methods need not to be validated ( only system suitability required). Any one pls suggest how to deal with this ??

In my opinion only selectivity and sensitivity if you have the same impurities profile but if you have an extra impurity you should validate this impurity.

I would not even dream of using one of these crappy methods without validation.

It's a nightmare to use this methods, just spend some time to develop a good method.

Personally, I would verify and document that you obtain comparable results using the USP method, USP test methods are considered already validated. And, yes, some are quite "interesting", requiring stuff like temperature-programable GC inlets, or requiring USP-supplied reference standard but USP does not yet sell that material. It's probably a good lesson: just because a test method is considered "official", doesn't mean it's logical or straightforward. Official bodies seem to stay with "tried and true" equipment rather than embrace some of the newer technologies.

if, given liberty i will never use these methods but since i have to comply to these official monographs , i have to use the same method. As indicated in USP , the method are already validated but regulatory bodies of unregulated markets are asking for validation data ( these days hey have learned the buz word"Validation").

I am also looking one USP monograph ( still in forum stage) that gives the RRTs of different impurities( fixed RRT no range ) in a Gradient HPLC??. Now the problem is by using two different HPLCs and different column make, i am geting different RRTs of some of the impurities. It really pissed me off to correlate my data to reported RRTs, they never match. Since USP does not provide standards for these impurities , it is quite impossible to match RRTs.what am i suppose to do???????????????????????

The USP provides info which column was used. Ask them!

USp is providing some relaxation to change their methods some extent. You can change your buffer strength, organic modifier, Ph etc.. with in allowable range. You can try this to get expected RRT's for your product.