GMP NEWS 2014

The British MHRA (Medicines and Healthcare Products Regulatory Agency) has published a guidance for developers of "software as a medical device"  = "stand-alone software". The text also expressly addresses "apps". Get the details here.

Due to changes in their careers, to professional re-orientation or due to retirement, four of the RMM board members will step out from their RMM activities and leave the board of the group. Read more about the new members here.

The USP published the draft of the revised chapter 1223 "Validation of Alternative Microbiologiocal Methods." Read more.

The US FDA has placed the Chinese company Beijing Shunxin Meihua Bio-technical Co on an import alert. Read more here about the FDA Import Alert.

In cases of serious deviations from the GMP requirements, the US FDA issues Warning Letters to the companies concerned. In some current Warning Letters from 2014, significant GMP deficiencies with regard to IT topics can be found. Read more.

Marck Biosciences Limited is a producer of sterile products which has been producing sterile products for the US market. The FDA Warning Letter dated July 8, 2014 contains shocking details about the GMP situation at this facility. Read more here about the FDA Warning Letter to Marck Biosciences and about the name change to Amanta Healthcare.

Delamination is a phenomenon that can occur repeatedly in glass containers. The glass particles emitted into the solution can pose a risk especially for parenteral drugs. Read the current view of the FDA on this topic.

The EMA has published the final guideline on the use of Near Infrared Spectroscopy (NIRS). NIRS is one of the most important technologies in PAT applications. The guideline covers qualitative and quantitative NIRS applications. Particularly worth mentioning is the fact that an addendum on the guideline's scope was published just in June 2014. You will find further information in this news.

The European Medicines Agency (EMA) published a concept paper on viral safety of plasma-derived medicinal products with respect to hepatitis E virus and wants to organise a workshop to address the relevant issues. Read more.