FDA 483 Observation caused by wrong SOP for Method Transfer

An inspection of a drug manufacturer ended with several observations were related to inadequate transfer of analytical methods. In one instance the SOP did not require the receiving laboratory to demonstrate suitability for intended use No specific reason was given. Another SOP was found to be inadequate because it listed several reasons why formal transfer is not required, for example, the analysis technique was already in use at the receiving: laboratory.
While the USP draft chapter <1224> describes waivers as one possible option for method transfer, obviously the justifications given by the company have not been accepted by the inspection team. You can preview excerpts.