Abstract
This paper provides readers a convenient compilation of open access literature including journal articles and PhD theses published by the Pharmaceutical Regulatory Science Team (PRST) over the last several years on the topics of Quality Risk Management (QRM) and Knowledge Management (KM). These topics, established as the dual enablers of a modern pharmaceutical quality system (PQS) as defined in ICH Q10, have been an area of focus of several PhD research studies over the past several years. A common theme across these research studies, as presented across this compilation of papers, is to advance PQS effectiveness and the goals of ICH Q10 through improving the understanding, application, and ultimately – the effectiveness – of QRM and KM as foundational enablers.
A goal of the PRST is to publish via open access channels to disseminate findings as quickly and as broadly as possible, and a vast majority of PRST-led papers are indeed available open access. The balance of this paper provides a listing of QRM and KM-related literature, including the paper title, authors, abstract, year published, and URL to the complete open access text.
DOI
https://doi.org/10.21427/p8ty-c619
Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-Share Alike 4.0 International License.
Recommended Citation
Lipa, Martin J. and Greene (editor), Anne
(2024)
"Advancing the Effectiveness of Pharmaceutical Quality Systems via QRM and KM: A Compilation of Open Access Literature by the PRST,"
Journal of Applied Pharmaceutical Regulatory Science:
Vol. 1:
Iss.
3, Article 5.
doi:https://doi.org/10.21427/p8ty-c619
Available at:
https://arrow.tudublin.ie/japrs/vol1/iss3/5
