Are method development and method validation two separate tasks or are there aspects of method validation that can be performed during the method development phase?

Method development and validation are two sepearte processes, but in developing the method you should always consider that you will have to validate it and transfer it to other sites. So, keep the method as simple as possible. You could perform the linearity, precision, LOQ, and LOD during the development cycle, but you generally write the validation protocol after the method has been developed. Go to www.waters.com for a good outline of the validation cycle. No, I don't work for waters.

Method development and validation are separate cups of tea when you are working in a regulated environnment. The its nice to have a neat dokumentation of your development activities, but you need full GxP documentation for the validation, including validation protocol, method description, characterised standard substances.....

By the time the method is said as developed , the validation is also completed. becasue , in order not to have any deviation during validation , we used to develop the methodds in such way that the vlaidation also takes place simultaneously.

Ths data we call it as pre-validationdata.

Thanks for all your comments. So if I understand things correctly you perform method development, e.g. column selection, detector selection, and optimization of the separation. Then you need to write a validation protocol and then validate the method, e.g. selectivity, linearity, accuracy, precision, LOD, LOQ, etc. If you do none of these activities in the method development phase, how do you know what to set the acceptance criteria at for the validation protocol?

In the development phase you test the limits of the method by doing serial dilutions, playing with the detector sensitivity, etc. Then you have an idea of what linearity range you can specify in the validation protocol.

Dear Anonymus-1;

I see you are getting a lot of good advice, so I will just a couple of comments. Normally people likes to keep the development and validation processes in separate documents. Obviously when you develop a method you should have an idea of how well the method will perform. With these ideas then you can go ahead and validate the method knowing what to expect.

The problem in a regulated environment is that once you reach the validation stage you are commited to achieve some method characteristics in the protocol, in other words, you are expected to predict the validation results before doing the validation. Obviously this is seemingly ilogical on the surface.

That is why most people writes the protocols in a very liberal way, giving a lot of room for the expected results. During the process you can also write amendments to the protocol, but people in the regulatory environment does not like to see too many of those attached to the original protocol.

The best situation is to develop the methods as the product goes into trials or tests. In the early stages, most people gives you a lot of room to develop and preliminary validate methods. Later on when the product is almost in commercial stage or registration stage, then the methods are known and you know what to expect from them before the full validation.

I hope all these comments help you.

Benjamin