Hi,
I am organic chemist ,just join the analytical department in pharma. I have been informed myself in that domain extensively and found quite a lot of info about validation,..HPLC method. My questions are, since I am a beginner, I need to know exactly how could I validate a method from A to Z? when should I validate a method? in the begining of developement process? on each intermediates or only final compounds? Do I need to determine a detector level for each method?
What are the neccesary data I should prepare and have beforehand for transferring a method to outsoruce company?
Any practical info concerning HPLC work in industry is very much helpful for me.
Thank you in advance

Whew! That's a pretty tall order. Good info. on methods validation is available in the USP, Section 1225 - Validation of Compendial Methods. You might also want to try the FDA Guidance page at:

http://www.fda.gov/cder/guidance/index.htm

When to validate? That's a good question. My understanding is that you really aren't required to have validated methods until fairly late in the product development cycle (Phase II/III). However, if you wait too long, there is always the risk that problems with the method may become apparent during validation and all of the sudden you find the method you've been using for years isn't accurate. Validation is expensive and you don't want to invest the time and energy into completing one unless you're fairly certain that you have the final product and formulation ironed out. The way we try to balance cost versus risk is to perform a mini-validation (aka qualification) early in the method life cycle after development is complete to provide ourselves with some assurance that it really does work. For example, we may evaluate only accuracy and precision.

I believe that every method used to evaluate pharmaceutical raw materials, intermediates, and final products needs to be validated .

As a general rule of thumb, the more information you can provide the contract laboratory, the better. However, each lab is different and the best thing to do is call them and discuss your needs with them. Each situation is different and needs to be evaluated individually.

Hope this helps.

Best Regards,

Michael Hinsberg

http://www.hinsbarlabs.com

Hi Michael,
thank you very much for taking of your time to giving me quick answer. It certainly helps me alot.
Catherine
P.S. For some reason, the anonymous button was chosen when I posted the message!