Part 1 of the guide to analytical method development unraveled the steps and questions in development. Part 2 speaks to the qualification or pre-validation phase in analytical method development.
An analytical method development guide to assist you in your analytical journey to provide the basic questions to ask, determine the purpose, and provide a starting point.
Remote agency inspections have become a necessity due to COVID-19. These are additional considerations to prepare ahead of for the best possible experience.
Capacity is a concern at parenteral suppliers as we work towards success in developing a global COVID-19 vaccine. Drug manufacturers and contract fillers are working together to address capacity limitations.
Within the last year we have seen our share of quality issues hit the airwaves. The troubles in India with Ranbaxy and Wockhardt have spurred some excellent discussion of how to drive the concepts of quality home within pharma.
As major blockbuster drugs come off patent, the scramble among generics to capture these new markets is just beginning. We can expect the U.S. market to experience continued change and consolidation with cost cutting remaining at the top of the priority list for big pharma.