Aseptic Process Validation and Aseptic Process Simulation Studies (single user digital version)

Apr 2009
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PDF Single user
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This chapter is taken from the book Practical Aseptic Processing: Fill and Finish, Volume 2

This chapter will present concepts related to the validation of aseptic processing for the manufacture of sterile drug products. It will focus on those elements of aseptic processing which affect product sterility. It will provide background into the concepts and approach to aseptic process validation and will discuss in detail, the planning and execution of aseptic process simulations.

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Format: Digital PDF (1 file - 243 KB)

Table of Contents

Table of Contents:

  • Process Validation
  • Validation of the Aseptic Process
  • Validation and the Assurance of Product Quality
  • Risk Management
  • The Validation Program
  • Planning
  • Design Control
  • Equipment Qualification
  • Aseptic Process Validation Approach
  • Aseptic Process Simulations
  • Elements of the APS
  • Preparation
  • APS Prerequisites
  • Designing the APS Study
  • APS Study Design Consideration
  • Other Considerations
  • On-Going Process Evaluation and Assessment
  • References
  • About the Authors

    About the Authors

    Hal Baseman
    is Chief Operating Officer and a Principal at ValSource LLC, a validation consulting and service firm. He has over 30 years of experience in pharmaceutical operations, validation and regulatory compliance. Hal has held positions in executive, management, and technical operations at several drug manufacturing and consulting firms. Hal is a long time member of the PDA and its Training Research Institute faculty, as well as the ISPE. He is a frequent presenter on subjects related to Quality Risk Management, Validation, and Aseptic Processing. Hal has served as a member of the PDA Board of Directors, Co-Chair of the PDA Science Advisory Board, Co-Leader of the PDA Validation Interest Group, Co-Chair of the PDA Aseptic Process Simulation Technical Report #22 Task Force on Aseptic Process Simulation, and Co-Chair of the PDA Risk Management Task Force responsible for writing Technical Report #44 on Quality Risk Management of Aseptic Processes. Hal co-chaired and led the 2009 PDA response to the FDA on the draft Process Validation Guidance revision. He has held positions on the ISPE Southeast Chapter and Suppliers Advisory Council, and the Pharmaceutical Blow Fill Seal International Operator`s Association (BFSIOA). Hal holds an MBA in Management from LaSalle University and a B.S. in Biology from Ursinus College.