Document Type

Theses, Ph.D


Available under a Creative Commons Attribution Non-Commercial Share Alike 4.0 International Licence


Health care sciences and services, Hospital administration, Public and environmental health, 3.4 HEALTH BIOTECHNOLOGY

Publication Details

Thesis submitted to the Technological University Dublin in fulfillment of the requirements for the award of Doctor of Philosophy (PhD), October 2017.


This thesis explores the application of quality risk management (QRM) in pharmaceutical and biopharmaceutical companies and its effectiveness at managing risk to the patient. The objective of the research described in this thesis was to characterize a maturity state of QRM implementation in which the patient is adequately protected from the risks associated with medicinal products of inadequate quality. The research was conducted over three phases: first, to determine whether patients are better protected since the publication of ICH Q9, a commonly employed guidance on the application of QRM; second, to characterize the industry with regard to QRM maturity, including the effectiveness of QRM application, the behaviors, attitudes, and motivations of the people working with and within QRM, and the governance and oversight of QRM efforts; and third, to construct a mature QRM program and associated maturity measurement tool to accelerate improvements in QRM and better protect the patient. The research employed a mixed methods approach, including the research methods of literature review, philosophical dialogues, benchmarking survey, semi-structured interview, and pilot case studies. The research concluded that the patient is no better protected since the inception of QRM and the level of QRM maturity throughout the pharmaceutical and biopharmaceutical industries remains rather low. However, the research also indicated that progression towards the more mature QRM model proposed in thesis may help firms perform QRM in a more effective manner, resulting in improved management of risk to the patient.