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FDA Guidance for Industry: The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP)


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA,

This guidance is intended to aid drug manufacturers (including ancillary testing laboratories) in the use of mechanical calibration as an alternate approach to the use of calibrator tablets in calibrating an apparatus used for dissolution testing. This guidance provides references to information on critical tolerances that should be achieved with mechanical calibration.

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