Method Transfer USFDA 483
Observation 6 in Sun Pharma Halol USFDA 483 on Method transfer.
Procedure for transfer of analytical test methods from Transferring Unit (TU) to Receiving Unit (RU) resembled analyst qualification and retest analysis as it only involved analysis of the same sample by TU analyst and RU analyst at the RU using same reagent, equipment, column, and reference standard. There is no variable involved in analysis conducted by both the Analysts to ensure transfer of method is accurate and reliable.
(https://www.fda.gov/media/187479/download)
What could be the expectation of the auditor here.
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