Since the early 2000s and the advent of the first guidance relating to mutagenic impurities developed by the European Medicines Agency (EMA), it has been necessary to assess the risk posed by mutagenic impurities. Although… Read more >
When a crisis occurs, hindsight is a great teacher. Any company developing or manufacturing products that impact human health can learn from the recent nitrosamine impurity contamination of angiotensin II receptor blockers (ARBs) by reviewing… Read more >
One scientist at a major global pharma company estimated that an analytical method could see up to 100 transfers in its lifetime. Increasingly, such transfers will take place across geographic borders. How ready are you to mobilize your methods?
Is your analytical method bound for the lab down the hall, or the lab halfway around the world? If you’re an analytical or QC scientist, get ready for more method transfers between organizations. We explore the complexities of analytical method transfer in part 2 of our ongoing series.
There’s a new analytical testing landscape taking shape, and it’s having a big effect on how we develop, transfer, and update methods. Data quality and business efficiency are both at stake. Are you ready?
