Particulate contamination is a risk in pharmaceutical production facilities. Good Manufacturing Practice (GMP) and proper risk management requires identifying root causes and evaluating what impact a particulate matter finding has on product safety. Understanding the...
As a pharmaceutical manufacturer, you need to know whether your products contain nitrosamine impurities and, if so, whether they are below the thresholds established by various regulatory agencies. Nitrosamine impurities can be introduced at any stage in the supply...
We are very proud that our CTO, Carsten Senholt, has a central role in the international writing group developing ISO 10993-17, which was recently submitted as a final draft. The ISO 10993 series is a suite of standards covering the biological evaluation of medical...
The EU is conditionally extending the MDR deadline. Medical device manufacturers with certificates approved before 26 May 2021 can extend their validity if their products meet certain conditions, one of which is the establishment of an MDR-compliant Quality Management...
According to EU Regulation (EC) 2017/745 (MDR) and US 21 CFR 820 covering medical devices, manufacturers must demonstrate that their selected critical suppliers, contractors, and consultants meet all specified requirements, including quality requirements. These...
The FDA Modernization Act to end animal testing has passed the US Senate. This change nullifies the old mandate requiring animal testing of all new drugs, thereby increasing the acceptance and use of Quantitative Structure-Activity Relationship (QSAR) and read-across...
