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The following is a list of all entries tagged with USP:
Drug Regulators, FDA – CDER, Publish Guidance on Use of Mechanical Calibration of Dissolution Apparatus CGMP
Filed in manufacturing, February 6, 2010, 4:52 pmThis 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.
Drug Regulators, FDA, Publish Guidance for Industry on Residual Solvents in Drug Products Marketed in the USA
Filed in manufacturing, December 29, 2009, 8:44 amThis guidance is intended to assist manufacturers in responding to the issuance of the United States Pharmacopeia (USP) requirement2 for the control of residual solvents in drug products marketed in the United States
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