Implementing Process Analytical Technology: The Challenges and Pitfalls of Applying a Science and Risk-Based Approach in Research and Manufacturing (single user digital version)

Jul 2008
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This chapter is taken from the book Risk-Based Compliance Handbook

Readers may well be familiar with the concept of risk management but not necessarily so with the concept of Process Analytical Technology (PAT). As this book is addressing risk from a lifecycle perspective, which in turn requires a profound understanding of the processes, and more importantly the quality attributes of the product, it is obvious that PAT needs to be addressed in this context.

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Format: Digital PDF (1 file - 112 KB)

Table of Contents

Table of Contents:

  • PAT Applications
  • Applying PAT — Worth the Risk?
  • From Data to Knowledge
  • PAT and the Regulatory Environment
  • References
  • About the Authors

    About the Authors

    Siegfried Schmitt, Principal Consultant, joined PAREXEL Consulting in 2007. He provides consulting services to the medical device and pharmaceutical industry on all aspects of regulatory compliance, particularly the design and implementation of Quality Management Systems and Competitive Compliance. Dr Schmitt`s areas of expertise include all aspects of quality and compliance for the product lifecycle, from R&D, to clinical trials, to commercialisation and post-marketing studies. He has previously held positions in industry as Senior Production Chemist with Roche and global Quality Director with GE Healthcare, and as Validation Manager with Raytheon and Senior Lead Consultant with ABB. Dr Schmitt is an active member of various industry associations, including DIA, PDA, RAPS and ISPE, conference presenter and organiser of international events. He is also an accomplished author and editor, having won the coveted `distinguished PDA author / editor award` for 2008.
    Dr Schmitt is a Chemist by background and holds Chartered Chemist and Chartered Scientist status. He is fluent in English and German. He is the author of The Manager`s Validation Handbook: Strategic Tools for Applying Six Sigma to Validation Compliance and Understanding Active Pharmaceutical Ingredients.

    Jennifer Thompson (previously Methfessel) is an IT and computer systems compliance expert with more than 15 years of experience across a wide range healthcare companies, system suppliers and service providers in the UK, Europe and USA. She joined ABB eight years ago where she is a Principal Consultant in Validation and Compliance Consultancy and works closedly with the ABB Process Analytical Technology Centre of Excellence. She has a special interest in PAT as she has a Ph.D. in physics, specialising in spectroscopic techniques. She is a Member of the Institute of Physics, chartered physicist and has a Diploma in Business Management. An active member of ISPE and GAMP, she regularly writes articles and presents at international conferences. Jennifer particularly enjoys applying her business knowledge and scientific training in working with clients to develop and implement risk-based strategies for PAT, business systems and IT and computerised systems compliance, validation and qualification.