ISO 10993-1 is the foundational standard for the biological evaluation of medical devices within a risk management process. It specifies the general principles for assessing the biological safety of medical devices that come into contact with the body. The latest...
Technically Unavoidable Particles (TUPs) are always present in excipients. Concern regarding their presence has increased dramatically in recent years due to several US FDA warning letters to pharmaceutical companies, highlighting adverse findings during inspections....
Medical device manufacturers must ensure the biosafety of their medical implant products to comply with relevant regulations. Medical implants have intimate contact with the human body for durations lasting a few hours to permanently. As such, they are subject to...
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...
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...
