"No Acceptance Testing during Method Transfer" cited in FDA 483

FDA expects firms to perform acceptance testing of analytical methods in the receiving laboratory when validated method are transferred between laboratories. The transfer and acceptance testing should follow formal transfer procedures. This became obvious during an inspection of a pharmaceutical manufacturer which resulted in a 12-page 483 inspectional observation from Jan 2013. One of the observation reads: "The firm failed to determine the acceptability of ten methods prior to using them in the QC laboratory through formal method transfer procedures". The 483 listed other observations, for example: inadequate method, validation, incomplete annual report, quality of incoming raw material not assured, inadequate training, process to endure data integrity not validated, data audit trails not maintained and instrument audit logs are not saved". You can preview excerpts. To learn everything about FDA compliant transfer of analytical methods attend the seminar: Transfer of Analytical Procedures According to the New USP Chapter <1224>. The seminar includes examples adequate acceptance criteria.