The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice (CGMP)

Title:
The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice (CGMP)

https://www.gmp-compliance.org/files/guidemgr/Mechanical_Calibration_Dissolution_FDA_2007.pdf

Origin/Publisher:

FDA

Document Type:
Guidance for Industry
Content:
This guidance is intended to aid drug manufacturers in the use of mechanical calibration as an alternate approach to the use of calibrator tablets in calibrating an apparatus used for dissolution testing.

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