Operational Excellence in the Pharmaceutical Industry by tyty722



Preface                                                                             9

Editors, Authors, and Acknowledgements                                              10

Introduction                                                                        12

List of Abbreviations                                                               14

I      Challenges in the Pharmaceutical Industry                                    17

       Gerrit Reepmeyer and Michael Kickuth

I.1    Declining R&D Productivity                                                   17
I.2    Changing Market Conditions                                                   21
I.3    Increasing Competition                                                       23
I.4    Increasing Costs and Low Operating Efficiency                                24
I.5    Implications for Manufacturing                                               26

II     A Reference Model for Operational Excellence                                 30

       Michael Kickuth, Thomas Friedli, Christoph H. Loch,
       and Stephen E. Chick

II.1   Introduction                                                                 30
II.2   Management Quality and Factory Performance                                   32
II.3   Developing the Operational Excellence Reference Model for the OPEX project   40


    III     The Status of the Pharmaceutical Industry                                 53

            Michael Kickuth, Thomas Friedli, Peter Thaler, Daniel Tykal,
            and Hermann Osterwald

    III.1   How Do Pharmaceutical Companies Respond to the Changing
            Environment?                                                              55
    III.2   Cost Savings Potential - What is the Main Leverage for Streamlining
            Operations?                                                               56
    III.3   Linking Practice to Performance: Testing the Operational Excellence
            Model                                                                     58
    III.4   Linking Operational Excellence to Overall Plant Performance               68
    III.5   Does Operational Excellence Matter from a Corporate Perspective?          69
    III.6   Insights from the Plant Audits                                             70
    III.7   Special Insights from a Contract Manufacturer – The Case
            of NextPharma                                                             77

    IV      Operational Excellence in the Pharmaceutical
            Industry: Case Studies from the Field                                     82

            Michael Kickuth, Thomas Friedli, Daniel Tykal,
            Marek Szwejczewski, Keith Goffin, Malcolm Wheatley,
            Bart Bastoen, Bart Dewolf, David Hampton, Christian Ewers,
            Christoph H. Loch, Stephen E. Chick, and Bruce Ramsay

    IV.1    Case Study: Launching an Operational Excellence Initiative
            in a Global Pharmaceutical Company - The Case of Pfizer Inc.              82
    IV.2    Case Study: The Capsugel Way to Operational Excellence                    95
    IV.3    Case Study: Maximizing Equipment Effectiveness at Reckitt Benckiser       102
    IV.4    Case Study: Achieving 6-Sigma Levels at a Pharmaceutical Plant            110
    IV.5    Lean Compliance: Implementing Just-in-Time (JIT) in a Regulated
            Environment                                                               124
    IV.6    The Role of Management Quality in the Context of Operational Excellence   131
    IV.7    Stages of Operational Excellence                                          138


V     The Pharmaceutical Plant of the Future       147

      Michael Kickuth and Thomas Friedli

V.1   The Pharmaceutical Industry in 2010          147
V.2   Implications for Manufacturing               150
V.3   How To Respond?                              153
V.4   The Plant of the Future                      164

Appendices                                         171

References                                         187


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