HPLC to UPLC method conversion, cGMP quality concerns
I work at a CMO manufacturing injectable drugs. Currently I am in charge of methods. We have recently upgraded to H-Class systems and I am in the planning stages of converting existing methods over to UPLC. Our quality department is being difficult when it comes to the discussion of transferring over methods to UPLC. Their concern is primarily related to the regulatory impacts. Basically they are saying there is no way to do this with established methods, and in particular methods associated with a drug filing. I know that what I am suggesting is sound from a scientific standpoint. Basically we need to demonstrate that the new UPLC method is equivalent to the existing HPLC method.I was hoping to start a discussion about what kinds of things need to be done in order to facilitate this transfer, and in particular, satisfy the concerns of my QA group.