Method Transfer：方法转移.pptVIP

Slide * Method Transfer Report Report items and format to be specified in the study transfer plan Summary of method familiarization results Detailed results of transfer study Description of any deviations and from expected results and how they have been resolved Signatures of individuals responsible for transfer studies Copies of supporting material, e.g., chromatograms and spectra Conclusion and assessment of the transfer study results Slide * Thank You I would like to thank All attendees for your attention Agilent Technologies for invitation and organizatopn Offer expires on March 10, 2014 Give feedback and choose any two from over 150 documents(value: $138) for free: SOPS and/or Validation examples.GOTO: /misc/conferences/feedback.aspx For links to Method Validation references, please check /agilent(Available until March 10, 2014) * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ? Copyright Ludwig Huber - LabCompliance Inter-Laboratory Method Transfer? Dr. Ludwig Huber Ludwig_huber@ RACI Conference - Chemical Analyses Slide * Overview Regulatory expectations Four approaches for analytical method transfer Experiments and acceptance criteria for comparative testing ?Effective planning, execution and documentation of method transfer Slide * Occurrence of Method Transfer Sponsor company to contract lab Analytical development to QC labs Across different sites The same lab conditions Different lab conditions Existing to new instrumentation With different specifications With different technology Supplier of material to client Transfer to new instruments with different instrument characteristics Slide * Transfer of Analytical Procedures Definition According to USP 1224 The transfer of analytical procedures (TAP), also referred to as method transfer, is a documented process that qualifies a laboratory (the receiving unit) to use an analytical test procedure that originated in an othe