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GUIDANCE DOCUMENT

The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP) Guidance for Industry January 2010

Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This 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. This guidance recommends that an enhanced MC procedure (such as the one recommended in this guidance) can be used as an alternative to the current Apparatus Suitability procedure for Dissolution Apparatus 1 and 2 described in USP General Chapter Dissolution. Regardless of whether the enhanced MC procedure or Apparatus Suitability procedure is used, the guidance also recommends that appropriate measures be taken to control the following sources of significant variability in dissolution testing: dissolved gases, vibration, and vessel dimensions.


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Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.