Guidance for Industry on the Use of Mechanical Calibration of Dissolution Apparatus 1 and 2-Current Good Manufacturing Practice; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2--Current Good Manufacturing Practice (CGMP)." This guidance recommends an alternative method for manufacturers to comply with FDA's CGMP regulations that require laboratory apparatus be calibrated at suitable intervals in accordance with established written specifications. The guidance is intended to aid drug manufacturers (including ancillary testing laboratories) in calibrating U.S. Pharmacopeia (USP) Dissolution Apparatus 1 and 2 to help assure that critical parameters associated with the dissolution apparatus meet certain mechanical calibration (MC) tolerances.