All-
A quality rep recently opened a corrective action on one of my labs regarding ALL of our HPLC methods- to verify that the integration paramaters currently used are the same as those used in validation. This came as a shock to me, since we purposely do NOT control integration parameters, since so many things can change and need optimization over the life of a method. We specify a retention time range, tailing, etc. in our system suitability, and then simply state that the entire run must be processed with the same integration parameters (no tweaks for individual chromatograms.) The processing parameters are printed with every analysis.
Am I crazy, does everyone else lock down integration parameters? Is this necessary for compliance to FDA/GMP etc?
Thanks-