With new regulations having established a need for the testing of certain elements correct sample preparation is crucial.
While there are some that choose to install a facility monitoring system just because regulatory guidance states one should be installed and used, many, given the choice, would choose not to.
This paper focuses on how to enhance a pharmaceutical production facility's process safety with a dynamic checkweighing system.
Europe and the United States are considered the world leaders in the safest pharmaceutical markets for patients. However, the US and Europe are also a lucrative target for drug crime.
The reality is that paper is more of a habit than a requirement. AstraZeneca discovered this when they aimed to introduce ELNs to improve the efficiency of their validated workflows for GMP API manufacture.
In 2008 Hollister did a thorough evaluation of available solutions to automate some key internal business processes including the tracking of product registrations and the management of CAPAs.
The drug-device combination product market is growing at a rapid pace. By 2019 it is expected that the global market for drug device combination products will reach $115.1 billion. This is nearly double its worth from $66 billion back in 2012. This burgeoning market will likely bring in a flood of product submission applications to the FDA at a time when resources are already strained.