GMP News - Analytical Quality Control

The introduction of the USP chapters in metallic impurities originally planned for 1st December 2012 has been postponed. Read more here about USP's reasons for that decision.

A new EMA Guideline on impurities of APIs manufactured by fermentation with eventual further synthetic steps defines precise requirements with regard to the information that has to be provided on these impurities. Read more here in the News.

Due to the rapid evolution of new practices and techniques for dissolution/drug release testing, FIP decided to revise the previous position paper from 2003. Get further information.

For curved calibration functions there exists some uncertainty how to establish a calibration which is in conformity with DIN/ISO standards. In this news you will be informed about new possibilities for performing the corresponding calculations.

The EMA has published the draft for a Guideline on the use of Near Infrared Spectroscopy (NIRS) in January 2012. NIRS is one of the most important technologies in PAT applications. The guideline deals with qualitative and quantitative procedures. You can obtain more information in this news.

The concept of parametric release has been primarily used for the sterility testing of products terminally sterilised. Now, the new EMA Guideline will extend this alternative release strategy - Real Time Release Testing - to all types of APIs and finished products testing. Read more here in the News.

In a press release from 21 May 2012, the EDQM warned CEPs holders (Certificates of Suitability) of fraudulent invoices. Read more in this News.