GMP News - Analytical Quality Control


Genotoxicity Research - New HMPC Guideline for Herbal Medicinal Products

A new HMPC Guideline contains suggestions on how genotoxicity testing in (traditional) herbal medicinal products can be simplified, so herbal products and preparations can be more easily included in the collective list ("community list"). Read all additional information here.



FDA Guidance on "Mechanical Calibration of Dissolution Apparatus" Passed

The final FDA Guidance for Industry on mechanical calibration of dissolution apparatus 1 and 2 was published in January 2010. Compared to the 2007 draft version, the guideline was completely revised; however, the conclusions and the recommended method for mechanical calibration remained unchanged. Read more here.



Recall of USP 33-NF 28!

During the conversion of monographs to a new design, errors have slipped into USP 33-NF 28. Therefore, the USP Convention recalls USP 33-NF 28 as a whole, and the pharmacopoeia will not come into force on 1 May 2010, which had originally been planned. Further information can be found here.



Recent Changes Concerning the USP Dissolution Performance Verification Test

On 1 December 2009, changes of the USP regarding the Dissolution Performance Verification Test came into force. Besides the General Chapter <711> was revised. Details can be found in our news item.


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