The Big Reshuffle —
Impact Assessments and System Criticality

ABSTRACT

A big reshuffle has been made in one of the principal guidelines for Commissioning & Qualification (C&Q) within the pharmaceutical industry today. The changes seek to improve the application of Quality Risk Management (QRM), a growing element of regulatory expectation. This research investigates the impact and implications of the changes to a key area of C&Q – namely impact assessments and system criticality. Have the current challenges been addressed by the update? Does the updated guidance provide clarity on the application of QRM to C&Q? This article explores how these changes bring a modern approach to C&Q.

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Laura Butchart

Validation Engineer

Laura Butchart is a validation engineer based in the UK and is currently studying the master’s degree programme, MSc in Pharmaceutical Validation Technology at TU Dublin. Laura also holds a bachelor’s degree in Medical and Environmental Microbiology and a City & Guilds Diploma in Steriliser Testing Technology. Laura has over twelve years’ experience in the validation covering IVD, MD and Pharmaceutical industries. She has had success with delivery of projects including start up and capital projects with experience in equipment qualification, facility qualification, computer system validation, process validation and cleaning validation. Laura has achieved varied process improvement activities with application of scientific and risk-based disciplines.

Michael S. Egan

Lead Validation Engineer, Novo Nordisk®, Assistant Lecturer, TU Dublin

Michael Egan is a Lead Validation Engineer based in Ireland with over twenty years’ experience in the pharmaceutical industry. Michael has graduated with distinction from two master’s degree programmes, MEngSc in Pharmaceutical & Biopharmaceutical Engineering from University College Cork and MSc. in Pharmaceutical Validation Technology from TU Dublin, winning the GetReSkilled Award for “Best overall dissertation performance 2015-16”. Michael is also an Assistant Lecturer for TU Dublin.
His knowledge extends to all areas of equipment/systems operation and validation including Equipment & System Qualification, Facility & Utility Qualification, CSV and Process/Cleaning Validation. He has success in the delivery of complex systems and processes through scientific and risk-based methods and approaches and has ambitions to become an industry leader as a technical SME/Design/Principal Engineer.

Donncadh J. Nagle

CQV Consultant, Jacobs Engineering; University Lecturer, TU Dublin

Donncadh Nagle is a pharmaceutical industry professional based in Ireland. Currently working as a Senior CQV consultant with Jacobs Engineering, he is also a Lecturer with the School of Chemistry & BioPharmaceutical Sciences at Technological University Dublin (TU Dublin).
Donncadh is an experienced validation engineer with over 17 years of experience in all areas of validation including; process/product validation, equipment/automation qualification, facilities qualification, computer system validation, test method validation, and cleaning validation.
Donncadh has ambitions to become an industry leader within the pharmaceutical industry and is part of the Pharmaceutical Regulatory Science Team (PRST), Dublin, Ireland. Currently researching and exploring the role emerging technologies, artificial intelligence and digitalization can play within the pharmaceutical industry. This research involves exploring possible use cases using these technologies while assessing potential regulatory impacts within the pharma and life sciences industries.
Other notable achievements / positions held:
  • Published author with IVT/JVT (USA), KENX (USA) and TU Dublin.
  • Winner of the 2019 Noel Whelan Memorial award (HPRA Academic Award)
  • KENX Insight Editorial Board member
  • Chair of the BPCI Validation group, Ireland.
  • Kneat Gx trained & guest speaker at Kneat VALIDATE 2023 & 2024
  • Designed new Digital Validation Module for TU Dublin 2024

Philip Jarvis
Director Integrated C&Q and Paperless Strategy, Veqtor Solutions

After Completing an Honors degree in Chemical Sciences at the University of Salford  ,Phil Joined J&J  for his first 10 years in the Medical device industry  mostly in Validation roles . Since then he has worked in validation /C&Q leadership roles at site and global levels for Various Pharma /Biopharma Companies including BioMarin, UCB, and AbbVie .

At AbbVie, Phil was responsible for the introduction of the Kneat paperless validation platform globally, he also developed and rolled out its risk based C&Q approach to the network .

He is currently the Director of integrated C&Q and paperless Strategy at Veqtor solutions.

Alma O’Reilly

Validation Manager at LEO Pharma Dublin

Alma O’Reilly is the Validation Manager at LEO Pharma, Dublin and is a researcher at the Technological University Dublin (TU Dublin). Alma has over 20 years’ experience in the pharmaceutical industry. In that time, she has worked in API, Bulk Process, Fill Finish and Packing Operations. She has extensive experience with automation systems, EBR, serialisation, clean utilities, CSV and equipment, cleaning, and process validation. She is currently heading up LEO Pharma’s drive to standardise C&Q systems and procedures across the group including 5 manufacturing sites. Alma holds an honours degree in Mechanical Engineering, a Master’s degree in Pharmaceutical Validation Technologies and is a published author with IVT/JVT, USA.

Phillip W. Isom

Small Molecule Engineering Strategy and Integration Consultant

Phillip (Phil) Isom is a pharmaceutical industry professional currently based in Ireland with significant global manufacturing experience (USA, Ireland, China, Japan). Phil is a Chemical Engineer by training with over seventeen years of experience in all areas of pharmaceutical manufacturing including; process engineering, quality assurance, engineering leadership, and operations leadership, across multiple technology platforms.  He has success in delivering complex global business process changes, including design and deployment of a streamlined global program for equipment qualification.

Siobhán Griffin

Project Engineer at Astellas Ireland Co. Ltd.

Siobhán Griffin is a pharmaceutical industry professional based in Ireland and is currently finalising her studies on the Master’s Degree programme, MSc. in Biopharmaceutical Science, a programme which is jointly offered by IT Sligo (the Institute of Technology Sligo) and NIBRT (National Institute for Bioprocessing Research and Training). Siobhan has over ten years of experience in the pharmaceutical industry in the areas of engineering, validation, projects, quality and regulatory affairs.

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