GMP NEWS 2012

From FDA's point of view, the science exists to enable continuous manufacturing in the pharmaceutical industry and there are no regulatory hurdles for implementing it. However, there is a lack of necessary experience. Read more 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.

Problems in connection with computerised systems have also been addressed in two actual FDA Warning Letters. Read more here.

The new rules for the importation of active pharmaceutical ingredients will already enter into force next year. As of 2 July 2013 each consignment of active substances imported into the EU must be accompanied by a written GMP conformity certificate. The European Commission comments once again the most important questions concerning the written confirmation in an information leaflet. Read more here.

The ECA Rapid Microbiological Methods working Group added new reports and articles to the literature list on its website . More can be found here.

Within FDA's scope - to review and, as necessary, update biologics regulations, to keep pace with technological developments and to boost regulatory science, the US authority published amendments to the sterility testing rule. Read more about the background and contents.

The EDQM has recently published a document intended as a guide for the renewal or revision of a certificate of suitability. The EDQM hopes that this will reduce the time needed for the procedure and limit requests for additional information from CEP holders. Read more about this very helpful document here.

Recently, the European Medicines Agency published an Reflection Paper on classification of advanced therapy medicinal products. This document is open for consultation until 31 July 2012. Read on.