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Risk Management in Pharmacy Production

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Practical Pharmaceutics

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Abstract

This chapter provides a basic knowledge on state-of-the-art approaches and applications of risk management in the pharmaceutical field. It focuses on hospital pharmacy preparation and manufacturing activities. Risk management is a mandatory part of an effective quality management system which delivers patient safety and includes product and employee safety. Recent developments on understanding risk management throughout the product lifecycle triggers a broader approach to handling hazards related to automatization and digitalization. (ICH Q9 Draft www.ema.europa.eu/en/ich-q9.quality-risk-management) or hospital pharmacist’s role as stewards in patient’s medication (EAHP. www.eahp.eu/sites/default/files/eahp_position_paper_on_patient_safety_october_2020).

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References

  1. ICH Q9 Draft. www.ema.europa.eu/en/ich-q9.quality-risk-management

  2. EAHP. www.eahp.eu/sites/default/files/eahp_position_paper_on_patient_safety_october_2020

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Author information

Authors and Affiliations

  1. Pharmacy, Apotheke des Klinikums Stuttgart, Stuttgart, Germany

    Elfriede Nusser-Rothermundt

Authors
  1. Elfriede Nusser-Rothermundt
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Correspondence to Elfriede Nusser-Rothermundt .

Editor information

Editors and Affiliations

  1. Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands

    Paul Le Brun

  2. Pharmacy Department, MINT URM Inserm 1066 CNRS 6021, University of Angers, CHU Angers, Angers, France

    Sylvie Crauste-Manciet

  3. Apotheke der Universitätsmedizin, Mainz, Rheinland-Pfalz, Germany

    Irene Krämer

  4. JCS Pharma Consulting Ltd., Newport, Gwent, UK

    Julian Smith

  5. Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen, The Netherlands

    Herman Woerdenbag

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Nusser-Rothermundt, E. (2023). Risk Management in Pharmacy Production. In: Le Brun, P., Crauste-Manciet, S., Krämer, I., Smith, J., Woerdenbag, H. (eds) Practical Pharmaceutics. Springer, Cham. https://doi.org/10.1007/978-3-031-20298-8_36

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  • DOI: https://doi.org/10.1007/978-3-031-20298-8_36

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-031-20297-1

  • Online ISBN: 978-3-031-20298-8

  • eBook Packages: MedicineMedicine (R0)

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