FDA Guidance on "Mechanical Calibration of Dissolution Apparatus" Passed

In October 2007, the FDA had published the Guidance for Industry "The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice" as a draft. In January 2010, the final version of this document was now released.

The text of the final version was completely revised. However, the consequences and conclusions remained unchanged.

The detailed representation of the affair round the difficulties with the Prednisone and Salicylic Acid Tablets was deleted. Instead, there are references to more recent investigations that have been conducted among others by the Division of Pharamceutical Analysis (DPA) within FDA's CDER.

The more recent developments concerning the USP since 2007 are also described. There, the term "calibrator tablets" is not used any longer, and in the General Chapter <711>, the test is now also called "Performance Verification Test, Apparatus 1 and 2". And since December 2009, in addition, the Salicylic Acid Tablet RS does not appear as a reference standard in the "performance verification test" any more, whereas the Prednisone Tablets RS are still mandatory (see GMP News from 3 February 2010).

There is no doubt about the guideline's conclusion: The FDA allows the users to opt for an enhanced procedure for the mechanical calibration ("enhanced MC procedure") instead of the present "apparatus suitability procedure" required by the USP General Chapter "<711> Dissolution Testing" for dissolution apparatus 1 and 2".

The guideline includes a direct reference to a corresponding method used by CDER/DPA. And from the FDA's point of view, this is the better method!

This is going to be an interesting point in future FDA inspections. Strictly speaking, the FDA inspectors have to verify implementation of and compliance with the USP requirements in cGMP inspections. And here we are facing an FDA Guidance that directly contradicts the USP requirements!

Apart from this, the final Guidance for Industry includes a great number of other pieces of information that are of interest to the users at the dissolution laboratories.

The final guidance document of January 2010 can be found here.

And the enhanced MC procedure favoured by the FDA can be viewed here.

These current developments will also be discussed during the ECA Education Course "Dissolution Testing" in Berlin, Germany, from 13-15 October 2010. The programme also includes a guided tour of the new dissolution laboratory of Bayer Schering Pharma in Berlin. Further programme details can be found following this link.

Author.
Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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