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Integration of Risk Management into existing Pharmaceutical Quality Systems

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Risk-based approaches including risk management are applied in many areas of business, e.g., automotive, oil and aerospace industries, finance, and insurance. Although there are some examples of the use of quality risk management in the pharmaceutical industry, they are rather limited and do not represent the full possible contributions that risk management has to offer
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    Integration of Risk Management into existing pharmaceutical Quality Sys-tems Masterarbeit von Mag. Dr. rer. nat. Siegfried Adam eingereicht am Lehrstuhl Wirtschafts- und Betriebswissenschaften der Montanuniversität Leoben Leoben, am 25. Oktober 2013   ii Eidesstattliche Erklärung Ich erkläre hiermit, dass ich die vorliegende Arbeit selbstständig und ohne fremde Hilfe  verfasst, andere als die angegebenen Quellen nicht benutzt und die benutzten Quellen zi-tiert habe. Die Arbeit wurde bisher in gleicher oder ähnlicher Form keiner anderen Prü-fungsbehörde vorgelegt und noch nicht veröffentlicht. Gratkorn, im Oktober 2013 ……………………………………. (Siegfried Adam)  Table of content iii Table of content    Table of content ............................................................................................................ iii   List of figures ................................................................................................................. v    List of tables .................................................................................................................. vi   List of abbreviations .................................................................................................... vii   1   Introduction .............................................................................................................. 1   1.1   Status quo of the pharmaceutical industry ....................................................................... 1   1.2    Aim of this work ................................................................................................................... 3   2   Quality management and pharmaceutical quality systems ..................................... 6   2.1   Quality and the management of quality ............................................................................ 6   2.2   Quality management systems ........................................................................................... 10   2.3   Pharmaceutical quality management ............................................................................... 13   3   Risk management and specifics of the pharmaceutical industry .......................... 23   3.1   Introduction and historical overview .............................................................................. 23   3.2   General aspects about risk ................................................................................................ 25   3.3   Risk management ............................................................................................................... 26   3.4    Aspects of risk management in selected industries ....................................................... 34   3.4.1   Risk management in the offshore oil and gas sector ........................................ 35   3.4.2   Risk management in the food industry ............................................................... 36   3.4.3   Supply chain risk management ............................................................................. 37   3.4.4   Financial risk management .................................................................................... 39   3.5   Pharmaceutical risk management ..................................................................................... 40   3.5.1   Introduction ............................................................................................................ 40   3.5.2    The pharmaceutical risk management process .................................................. 42   3.6   Risk management tools ...................................................................................................... 45   3.6.1   Basic risk management facilitation methods ...................................................... 46   3.6.2   Failure Mode and Effects Analysis (FMEA) ...................................................... 47   3.6.3   Fault Tree Analysis (FTA) ..................................................................................... 49   3.6.4   Design of experiments (DoE) .............................................................................. 50   4   Integration of risk management into existing quality systems ............................. 53   4.1   Preliminary aspects of management system integration ............................................... 53   4.2   Integration of risk management ....................................................................................... 58   4.2.1   Risk management policy ........................................................................................ 59   4.2.2   Risk-based change control .................................................................................... 59    Table of content iv 4.2.3   Deviation management .......................................................................................... 62   4.2.4   Risk-based raw material supplier qualification ................................................... 67   4.2.5   Pharmaceutical complaint management ............................................................. 73   4.2.6   Risk-based planning of self-inspections .............................................................. 74   5    Analysis of the potential of the integrated quality risk management system, further strategic development and outlook ............................................................ 78   6   Conclusion and outlook ......................................................................................... 86   List of literature ............................................................................................................ 87  
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