New USP Publication: Monitoring Humidity during Transportation?
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.
New EMA Guideline on Specifications for Impurities in Antibiotics
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.
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.
Curved Calibration Functions - how to perform the Regression Calculation?
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.
FDA Expectations concerning Real Time Release Testing (RTRT)
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.
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.
USP Article about new USP NIR System Suitability Reference Standard
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.
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.
How to set Specifications for Genotoxic, Metallic Impurities and Residual Solvents in APIs?
The EMA has recently extended its Questions and Answers collection with three statements regarding the setting of drug substance specifications for potentially genotoxic, metallic impurities, and solvent residues. More details here.
According to a notice from the EDQM with regard to a meeting of the Pharmacopoeial Discussion Group (PDG) 28 of the 35 General Chapters and 41 of the 61 monographs on excipients are currently harmonised. You will find more about the latest status relative to the PDG working group in this news. The strategies for an efficient management of the different pharmacopoeial requirements (EP, USP, JP) are also the topic at an international Pharmacopoeia conference in Prague.