In addition to careful adherence with all applicable regulatory and Customs requirements, sponsors should understand and be sensitive to the cultural and business norms of each country included in their study.
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.