GMP News - Analytical Quality Control

The US American Pharmacopoeia USP has informed about its plan to replace the title of General Chapter <41> "Weights and Balances" by "Balances" and also to revise General Chapter <1251> "Weighing on an Analytical Balance". More details about the current proposals regarding the qualification of analytical balances can be found here in the News.

What are the risks of humidity excursions during transportation of products (medicinal products, APIs, intermediates)? A current publication in the USP Pharmacopeial Forum has examined the question. Read more here about the USP article.

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USP has withdrawn a standard for the Apparatus 3 Performance Verification Test for dissolution testing as of February 2012.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.