GMP News - Analytical Quality Control

In June 2012 the EMA posted a new question in the Q&A part on quality of medicines regarding how to set specifications for genotoxic and potentially genotoxic impurities. Read more.

FDA aids the pharmaceutical industry in developing generic drug products by providing a database on methods for active drug dissolution testing. The most important functions are described in the FDA document "Frequently Asked Questions". You can obtain more information in this news.

USP has withdrawn a standard for the Apparatus 3 Performance Verification Test for dissolution testing as of February 2012. Get more information, also about the background - in this news.

The FDA has highlighted the importance of Real Time Release Testing (RTRT) in a publication. It explicitly supports the implementation of RTRT approaches in the pharmaceutical industry.  When RTRT is used, it is part of the control strategy and can include some or all of the final critical quality attributes (CQAs). Please click here to obtain more information in this news.

In an article of the USP Pharmacopeial Forum, the authors give reasons why the continued use of the USP NIR System Suitability Reference Standard is recommended. More about the USP article and the verification of wavelengths of NIRS systems by calibration standards can be found here.

The EMA has recently extended its Questions and Answers collection with three statements regarding the setting of drug substance specifications for potentially genotoxic, metallic impurities, and solvent residues. More details here.

According to a notice from the EDQM with regard to a meeting of the Pharmacopoeial Discussion Group (PDG) 28 of the 35 General Chapters and 41 of the 61 monographs on excipients are currently harmonised. You will find more about the latest status relative to the PDG working group in this news. The strategies for an efficient management of the different pharmacopoeial requirements (EP, USP, JP) are also the topic at an international Pharmacopoeia conference in Prague.