Mechanical Calibration Of Dissolution Apparatus 1 And 2

Mechanical Calibration Of Dissolution Apparatus:

“The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice” was published by the FDA in October 2007 as a draft.

This document was finally published in January 2010. With the name of “The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP)”.

The text of the final version has been completely revised. However, the conclusions and consequences remained the same.

The purpose of this guideline is to assist drug manufacturers (including ancillary testing laboratories) with calibrating U. S. Pharmacopeia (USP) Dissolution Apparatus 1 and 2 to ensure that certain mechanical calibration (MC) tolerances are met.

In this guidance, it is recommended that an enhanced MC procedure (like the one recommended here) be used as an alternative to the current USP Apparatus Suitability procedure for Dissolution Apparatus 1 and 2.

This guidance makes the recommendation to control the following sources of significant variability in dissolution testing, regardless of whether the enhanced Mechanical Calibration procedure or apparatus suitability procedure is used: dissolved gases, vibration, and vessel dimensions.

The detailed explanation of the difficulties with the Prednisone and Salicylic Acid Tablets was deleted.

The report contains references to more recent investigations that have been conducted, among others, by the Division of Pharmaceutical Analysis (DPA) within FDA’s Center for Drug Evaluation and Research.

A test has also been renamed “Performance Verification Test, Apparatus 1 and 2” in the chapter which previously used the term “calibrator tablets”.

In addition, since December 2009, the Salicylic Acid Tablet RS has no longer been included as a reference standard in the “performance verification test”.

“The FDA allows users to choose an enhanced mechanical calibration procedure (“enhanced MC procedure”) instead of the current “apparatus suitability procedure” required by USP General Chapter “<711> Dissolution Testing” for dissolution apparatus 1 and 2

The Fianl document can be found here: Mechanical Calibration Of Dissolution Apparatus