Chromatography Forum

hi everybody,
normally for validation of a formulation, specificity is done during validation only not during development. i feel it should be check during development .if the specificity fails then it comes back to the development team . if it is done before validation during the development it will save time , money and man power. i am new to this feild , is my argument worth.
regard
zydus

Trial lawyers in the US are taught a simple rule: "never ask a question to which you do not already know the answer.". That same rule applies to validation. All of the aspects of validation should have been checked *before* the formal validation process begins.

That is what we call method development and evaluation. I will briefly evaluate the method before the formal method validation protocol be signed off.

Zydus

I would disagree with that argument. What you're suggesting is that the analytical development team might say to the formulators, "don't use that ingredient, because it makes things difficult for us development and QC people". But I don't think most pharma companies would agree with that logic. Their thinking will be to develop whatever formulation makes the most sense (in terms of efficacy, safety, stability, etc), and then the analytical people will simply have to figure out how to deal with it.

Adam

hi everybody,
normally for validation of a formulation, specificity is done during validation only not during development. i feel it should be check during development .if the specificity fails then it comes back to the development team . if it is done before validation during the development it will save time , money and man power. i am new to this feild , is my argument worth.
regard
zydus

dear frens,
i dont mean that the formulation should be according to analyst convinient. we always try to minimise the risks of failing a method.if the placebo interferes with analyte then its the duty of development team to develop again a new methods. as far as specificity is concern we take longer time to develop unlike other parameter. so i just feel to evaluate it before transfering to the validation team so that there will be less chances of failure.
lastly thanx everybody for sugestion

Analytical method development and Drug Product development is a parallel process. But once drug product is finalized, the analytical method should be checked for all the parameters including specificity, precision and recovery before carrying out the validation work as per protocol.

I support!