The EU Commission has published the long-awaited, revised chapters 3 and 5 of the EU GMP Guide. The change focuses on the prevention of cross-contamination as well as on the statement concerning the need for dedicated facilities. Continue reading.
The Pharmaceutical Quality Group (PQG) and the GDP Interest Group of the ECA Foundation have established a task force which is currently working on the interpretation of the EU Good Distribution Practice (GDP) Guide. Read more about the new GDP interpretation.
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.
FDA published a draft Guideline on Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices. It is a result of FDAs activities to reduce the outbreaks of Toxic Anterior Segment Syndrome (TASS). Read more here.
During the first months of 2014, the literature part of the RMM homepage was re-structured. More about the new structure of the subpages with the regulatory background, literature reports and articles about the different types of Rapid Microbiological Methods can be found here.
FDA's Guidance on Out-of-Specification Results has been seen as the state of the art regarding the handling of OOS results. In the meantime, Europe - through the British MHRA and the German ZLG - has also developed requirements on that topic. Read more here about the most important regulations of the respective guidance documents.
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.
On 7 July 2014 the US FDA has issued a Warning Letter for Zhejiang Jiuzhou Pharmaceutical Co., Ltd. located in Taizhou, Zhejiang Province in China. The company is a producer of APIs and failed to establish basic GMP principles. Please read more about the FDA Warning Letter.
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.