Document Type
Theses, Ph.D
Disciplines
3. MEDICAL AND HEALTH SCIENCES, Pharmacology and pharmacy
Abstract
Patients expect safe, effective, high-quality medicines that are available when needed. Meeting these expectations is increasingly challenging in a global pharmaceutical supply chain, as evidenced by persistent product quality and supply issues. A key contributory factor to these issues is disruptions in manufacturing operations, which in turn are often caused by a hesitancy to change and to continuously improve approved processes. Regulatory agencies repeatedly indicate that they will consider increased autonomy for post-approval changes, if pharmaceutical manufacturing operations can demonstrate the effectiveness of Quality Risk Management (QRM) within the Pharmaceutical Quality System (PQS). Thus, the question was posed by Dr O’Donnell of the Irish Health Products Regulatory Authority (HPRA), and echoed by other regulators, as to how QRM effectiveness within a PQS might be demonstrated?
DOI
https://doi.org/10.21427/3x08-jq90
Recommended Citation
Mulholland, Valerie, "Effective Risk-Based Decision Making in Quality Risk Management" (2024). Dissertations. 5.
https://arrow.tudublin.ie/schschpsdis/5
Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-Share Alike 4.0 International License.
Publication Details
A thesis submitted to Technological University Dublin in fulfilment of the requirements for the award of Doctor of Philosophy (PhD), July 2024.
doi:10.21427/3x08-jq90