Holistic Risk-Based Site Surveillance – A Data-Based Approach to Site Quality Risk Identification and Assessment in the Pharmaceutical Industry
Journal
Level 3
Type
journal article
Date Issued
2021
Author(s)
Abstract (De)
Effective quality risk management is fundamental in guaranteeing the development and manufacture of high-quality drugs, reducing drug shortages, and avoiding harm to patients’ health. The ability to accurately assess the actual risk environment, predict potential product quality or supply disruption issues and act to eliminate, prevent, reduce or mitigate them is key to improvements in quality management maturity. This paper illustrates a just-launched research project aimed at developing a comprehensive framework for how to assess and predict risks by leveraging a range of diverse factors.
Language
English
HSG Classification
contribution to scientific community
HSG Profile Area
SoM - Business Innovation
Refereed
No
Publisher
TU Dublin
Publisher place
Level 3
Volume
16
Number
1
Official URL
Subject(s)
Division(s)
Eprints ID
265303
File(s)![Thumbnail Image]()
Name
Data-based Approach to Site Quality Risk Identification and Assessment in the Pharmaceutical Industry.pdf
Size
387.38 KB
Format
Adobe PDF
Checksum (MD5)
330d2f2ec4569576356bcca4533a16cd