RD should design and develop the method with considering condition in the lab where the method will be applied, in this case, QC lab.
prior method transfer, we must ensure that all equipments needed from both labs have been validated or calibrated. it will minimize the transfer failure.
dear syx:
thanks for your kindly reply, but in my case, the problem is the people may do something out of my experience, i have no idea that if they are right or not, like they set up different run time for std and sample for saving time and eluent (i.e 22mins for std, 55mins for spl). they may keep the GMP document in their office which i was wondering they should be storaged in QA or in document management system.
different run time between sample- and standard-solution is ok since the chromatographic conditions (flow rate, mobile phase composition, temperature, etc) remain all the same. the usual main reason for this is we need more time to elute other substances in the sample solution. standard solution may contain only one substance, but the sample solutions may be a complex mixture. if the sample solution needs a very long run time, sometimes one perform gradient elution after the peak of analyte to get shorter run time. other approach is performing sample clean-up procedure, for example using SPE.