TY - THES

T1 - Integration of Risk Management into existing Pharmaceutical Quality Systems

AU - Adam, Siegfried

N1 - embargoed until null

PY - 2013

Y1 - 2013

N2 - This master thesis focuses on the implementation of risk management into existing quality systems as a need to assure future regulatory compliance and to prepare the pharmaceutical industry for various future opportunities and threats. In the case risk management has already been implemented in some systems, it was merely focused on relevant core processes, i.e. R&D, production and quality assurance. A sound quality management system can be regarded as a valuable primer and point of departure for risk management activities. The pharmaceutical industry has a long-lasting tradition with regard to quality management, hence lacked until now a more structured and systematic approach that can be realised by integration of risk management into existing quality systems. Hence, a basic introduction to quality management with a focus on pharmaceutical quality systems is provided. Before the integration of risk management is described, a sound introduction to risk management with regard to different standards, industries and tools is provided. The integration is performed by the means of a partial absorption and a process-oriented integration approach. The focus is set on common quality systems, i.e., deviation management, complaint management, planning of self inspections, supplier qualification and change management. Transformation and change management is taken into account and the integration of risk management into existing quality systems can be regarded as restructuring process. Finally it is suggested that based on the already performed integration, further integration steps with regard to risk management should be performed. As a next step, risk management is to be integrated into further quality relevant systems and a risk culture is to be implemented. Furthermore, it is clear that individual risk groups of different segments of a pharmaceutical company cannot be treated separately, as strong interdependencies exist, e.g. between quality risks and more general business risks, like risks caused by inadequate talent management that may affect product quality, time-to-market or specific compliance issues. Therefore, the ultimate approach for pharmaceutical companies towards risk should be realised by the means of an integrated enterprise risk management, taking into account quality risks and all other risks the pharmaceutical sector will face in the near and mid-term future.

AB - This master thesis focuses on the implementation of risk management into existing quality systems as a need to assure future regulatory compliance and to prepare the pharmaceutical industry for various future opportunities and threats. In the case risk management has already been implemented in some systems, it was merely focused on relevant core processes, i.e. R&D, production and quality assurance. A sound quality management system can be regarded as a valuable primer and point of departure for risk management activities. The pharmaceutical industry has a long-lasting tradition with regard to quality management, hence lacked until now a more structured and systematic approach that can be realised by integration of risk management into existing quality systems. Hence, a basic introduction to quality management with a focus on pharmaceutical quality systems is provided. Before the integration of risk management is described, a sound introduction to risk management with regard to different standards, industries and tools is provided. The integration is performed by the means of a partial absorption and a process-oriented integration approach. The focus is set on common quality systems, i.e., deviation management, complaint management, planning of self inspections, supplier qualification and change management. Transformation and change management is taken into account and the integration of risk management into existing quality systems can be regarded as restructuring process. Finally it is suggested that based on the already performed integration, further integration steps with regard to risk management should be performed. As a next step, risk management is to be integrated into further quality relevant systems and a risk culture is to be implemented. Furthermore, it is clear that individual risk groups of different segments of a pharmaceutical company cannot be treated separately, as strong interdependencies exist, e.g. between quality risks and more general business risks, like risks caused by inadequate talent management that may affect product quality, time-to-market or specific compliance issues. Therefore, the ultimate approach for pharmaceutical companies towards risk should be realised by the means of an integrated enterprise risk management, taking into account quality risks and all other risks the pharmaceutical sector will face in the near and mid-term future.

KW - Risikomanagement

KW - Qualitätsmanagement

KW - Pharmazeutische Industrie

KW - Integration

KW - Risk Management

KW - Quality Management

KW - Pharmaceutical Industry

KW - Integration

M3 - Master's Thesis (University Course)

ER -