Skip to main content

Main menu

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore

User menu

  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart

Search

  • Advanced search
PDA Journal of Pharmaceutical Science and Technology
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore
  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart
PDA Journal of Pharmaceutical Science and Technology

Advanced Search

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • Follow pda on Twitter
  • Visit PDA on LinkedIn
  • Visit pda on Facebook
Case ReportCase Studies

A Case Study in Application of the Risk Knowledge Infinity Cycle

Peer Schmidt, Martin J. Lipa, Jace Fogle, Owen Baker, Timothy Pawlak, Sean McEwen and Kevin O’Donnell
PDA Journal of Pharmaceutical Science and Technology May 2024, 78 (3) 367-383; DOI: https://doi.org/10.5731/pdajpst.2023.012931
Peer Schmidt
1AbbVie;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Martin J. Lipa
2TU Dublin & Pharmaceutical Regulatory Science Team (PRST); and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: martin.lipa@prst.ie
Jace Fogle
1AbbVie;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Owen Baker
1AbbVie;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Timothy Pawlak
1AbbVie;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Sean McEwen
1AbbVie;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Kevin O’Donnell
3Health Products Regulatory Authority (HPRA)
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

References

  1. 1.↵
    International Conference for Harmonisation. Quality Guideline Q10: Pharmaceutical Quality System Q10. ICH: Geneva, 2008. https://database.ich.org/sites/default/files/Q10Guideline.pdf
  2. 2.↵
    1. O’Donnell K.
    A Regulator’s Perspective on Quality Risk Management & Knowledge Management after 12 Years of QRM & KM—The Twin Enablers in ICH Q10. In PDA 2020 Europe Quality and Regulations Conference (Virtual); PDA 2020 Europe Quality and Regulations Conference (Virtual), 2020.
  3. 3.↵
    International Conference for Harmonisation. Quality Guideline Q9: Pharmaceutical Quality System. ICH: Geneva, 2005. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/%5CnGuidelines/Quality/Q9/Step4/Q9_Guideline.pdf
  4. 4.↵
    1. Calnan N.,
    2. Lipa M. J.,
    3. Kane P.,
    4. Menezes J. C.
    1. Calnan N.,
    2. Greene A.,
    3. Kane P. E.
    An Academic Perspective Knowledge Management: the Orphan Enabler—Enabling ICH Q10 Implementation. A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry; Calnan N., Lipa M. J., Kane P., Menezes J. C., Eds.; Taylor & Francis: Boca Raton, FL, 2018; pp 133–151.
  5. 5.↵
    1. Kane P. E.,
    2. Lipa M. J.,
    3. Greene A.,
    4. Calnan N. F.
    Knowledge Management Implementation: A Survey of the Biopharmaceutical Industry. ISPE Pharmaceutical Engineering 2020.
  6. 6.↵
    ISPE. ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry; ISPE: Tampa, FL, 2021.
  7. 7.↵
    International Conference for Harmonisation. Final Concept Paper ICH Q9(R1): Quality Risk Management. ICH: Geneva, 2020.
  8. 8.↵
    International Conference for Harmonisation. Quality Guideline Q9(R1): Pharmaceutical Quality System. ICH: Geneva, 2023. https://database.ich.org/sites/default/files/ICH_Q9%28R1%29_Guideline_Step4_2023_0126_0.pdf
  9. 9.↵
    1. Lipa M. J.,
    2. O’Donnell K.,
    3. Greene A.
    A Survey Report on the Current State of Quality Risk Management (QRM) and Knowledge Management (KM) Integration. Level 3 2021, 15 (3).
  10. 10.↵
    1. Lipa M. J.,
    2. O’Donnell K.,
    3. Greene A
    , Technological University Dublin. Managing Knowledge and Risk - A Literature Review on the Interdependency of QRM and KM as ICH Q10 Enablers. J. Validation Technol. 2020, 26 (4),
  11. 11.↵
    1. Lipa M. J.,
    2. O’Donnell K.,
    3. Greene A.
    Knowledge as the Currency of Managing Risk: A Novel Framework to Unite Quality Risk Management and Knowledge Management. Level 3 2020, 15 (2).
  12. 12.↵
    International Conference on Harmonisation. ICH Q9(R1) Training Materials; ICH: Geneva, 2023. https://database.ich.org/sites/default/files/ICH_Q9%28R1%29EWG_Training_Materials_2023_1005.zip
  13. 13.↵
    1. McEwen S.
    Out of Specification Test Results Remediation Case Studies. In PDA/FDA Joint Regulatory Conference; PDA: Washington DC, 2019.
  14. 14.↵
    1. Lipa M. J.,
    2. Mulholland V.
    Exploring the Risk Knowledge Infinity Cycle (RKI Cycle) Across the Product Lifecycle. ISPE Webinar. https://ispe.org/webinars/exploring-risk-knowledge-infinity-cycle-rki-cycle-across-product-lifecycle (accessed April 29, 2021).
  15. 15.↵
    1. Lipa M. J.
    Building a Solid Foundation for a Pharmaceutical Quality System—Presenting QRM and KM as United Enablers. Bioprocess Int. 2022, 20 (9).
  16. 16.↵
    1. Calnan N.,
    2. Lipa M. J.,
    3. Kane P.,
    4. Menezes J. C.
    1. Kane P. E.,
    2. Lipa M. J.
    The House of Knowledge Excellence—A Framework for Success. In A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry; Calnan N., Lipa M. J., Kane P., Menezes J. C., Eds.; Taylor & Francis: Boca Raton, FL, 2018; pp 181–224.
  17. 17.↵
    1. Beardsley S. C.,
    2. Johnson B. C.,
    3. Manyika J. M.
    Competitive Advantage from Better Interactions. McKinsey Quarterly 2006, (2), 52–63.
  18. 18.↵
    APQC. Introduction to Knowledge Management (KM). 2018. https://www.apqc.org/resource-library/resource-listing/introduction-knowledge-management-km-essentials-0.
  19. 19.↵
    1. Lipa M. J.,
    2. Mulholland V.,
    3. Greene A.
    Integrating Knowledge Management and Quality Risk Management. ISPE Pharmaceutical Engineering 2022, 42 (4), 14–23.
    OpenUrl
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 78 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 3
May/June 2024
  • Table of Contents
  • Index by Author
  • Complete Issue (PDF)
Print
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
Email Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
A Case Study in Application of the Risk Knowledge Infinity Cycle
(Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology
(Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
5 + 7 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
A Case Study in Application of the Risk Knowledge Infinity Cycle
Peer Schmidt, Martin J. Lipa, Jace Fogle, Owen Baker, Timothy Pawlak, Sean McEwen, Kevin O’Donnell
PDA Journal of Pharmaceutical Science and Technology May 2024, 78 (3) 367-383; DOI: 10.5731/pdajpst.2023.012931

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
A Case Study in Application of the Risk Knowledge Infinity Cycle
Peer Schmidt, Martin J. Lipa, Jace Fogle, Owen Baker, Timothy Pawlak, Sean McEwen, Kevin O’Donnell
PDA Journal of Pharmaceutical Science and Technology May 2024, 78 (3) 367-383; DOI: 10.5731/pdajpst.2023.012931
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • 1. Introduction
    • 2. Background on QRM, KM, and the RKI Cycle Framework
    • 3. A Case Study in Application of the RKI Cycle
    • 4. Discussion—Demonstrating How the RKI Cycle Links Back to Key Revision Topics
    • 5. Conclusion
    • Disclaimers
    • Conflict of Interest Declaration
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • No citing articles found.
  • Google Scholar

More in this TOC Section

  • Practical Application of Setting up an Annual Contamination Control Strategy (CCS) Assessment
  • Phase-Incremental Decision Trees for Multi-Phase Feature Selection and Interaction in Biologics Manufacturing
Show more Case Studies

Similar Articles

Keywords

  • quality risk management
  • ICH Q9(R1)
  • knowledge management
  • pharmaceutical quality system
  • RKI Cycle
  • Risk-based decision-making

Readers

  • About
  • Table of Content Alerts/Other Alerts
  • Subscriptions
  • Terms of Use
  • Contact Editors

Author/Reviewer Information

  • Author Resources
  • Submit Manuscript
  • Reviewers
  • Contact Editors

Parenteral Drug Association, Inc.

  • About
  • Advertising/Sponsorships
  • Events
  • PDA Bookstore
  • Press Releases

© 2025 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

Powered by HighWire