Business And Cultural Considerations When Managing Clinical Supplies For Asia-Pacific Studies
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.
WHITE PAPERS & CASE STUDIES
Aseptic Blow-Fill-Seal: A Sustainable Process For Packaging Pharma Liquids
Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and process that provide critical advantages for sustainable initiatives.
The Case For A Facility Monitoring System
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.
Enhancing Process Safety In The Pharmaceutical Industry
This paper focuses on how to enhance a pharmaceutical production facility's process safety with a dynamic checkweighing system.
Security Of Pharmaceuticals: A Comparison Of EU And US Standards
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.
How AstraZeneca Improved Validated Workflows In GMP API Manufacturing
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.
Selecting An Automated Solution For Tracking Product Registration And CAPA Management
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.