Firms can use practical tools and criteria to implement advanced analytical test methods for biopharmaceuticals. They an also extend and maintain the validation status for a licensed test method from an understanding of the relationship of historical process data, specifications and test method capability.
The PAT market is developing and evolving rapidly as pharmaceutical firms strive to implement the framework set in place by the regulators. As with all new markets, people will engage at different times, at differing rates, and for different reasons. This editorial seeks to treat PAT in classical marketing terms, describing four phases of the PAT market evolution and discussing how the PAT market will likely mature.
This article examines the development of a business case to secure coveted funding for a LIMS implementation. Information on hard cost savings and soft benefits of implementing a LIMS system, and managing the compilation of the cost justification are covered.
With all the challenges that the manufacturing industry has had to deal with over the last ten years - growing compliance demands, increased competition and price pressures - it is perhaps not surprising that pharmaceutical firms are increasingly trying to streamline their manufacturing processes to maintain profit margins, speed up the time-to-market, as well as comply with market regulations that are becoming increasingly stringent.
The evolution of sophisticated monitoring systems has been accelerated because of stringent EU legislation surrounding the pharmaceutical industry and the escalating demand for preventative maintenance techniques. This article gives an overview of the benefits of implementing these systems in pharmaceutical manufacturing.