The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice (CGMP)
Internet:
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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