Knowledge Management as a Pharmaceutical Quality System Enabler: How Enhanced Knowledge Transfer Can Help Close the ICH Q10 to ICH Q12 Gap

References

1. 1.↵
   International Conference for Harmonisation, Quality Guideline Q10: Pharmaceutical Quality System. ICH: Geneva, 2008.
2. 2.↵
   1. Kane P. A.

   Blueprint for Knowledge Management in the Biopharmaceutical Sector. Ph.D. Thesis, Technological University Dublin, 2018.
3. 3.↵
   International Conference for Harmonisation, Quality Guideline Q8(R2): Pharmaceutical Development. ICH: Geneva, 2009.
4. 4.↵
   International Conference for Harmonisation, Quality Guideline Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities). ICH: Geneva, 2012.
5. 5.↵
   International Conference for Harmonisation, Quality Guideline Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. ICH: Geneva, 2019.
6. 6.↵
   1. Vinther A.,
   2. Ramnarine E.

   Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transform Post-Approval Change Management. PDA J. Pharm. Sci. Technol. 2019, 73 (5), 517–521.

   OpenUrlAbstract/FREE Full Text
7. 7.↵
   1. Ramnarine E.,
   2. Vinther A.,
   3. Greene A.,
   4. O’Donnell K.

   Continual Improvement While Maintaining a State of Control: A Concealed Paradox or a Mutual Interdependence? J GXP Compliance 2019, 23 (6).
8. 8.↵
   1. Calnan N.,
   2. Lipa M. J.,
   3. Kane P. E.,
   4. Menezes J. C.

   1. Yegneswaran P. K.,
   2. Thien M. P.,
   3. Lipa M. J.

   ; Why Knowledge Management Is Good Business. In A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry; Calnan N., Lipa M. J., Kane P. E., Menezes J. C., Eds.; Taylor & Francis: Boca Raton, FL, 2018; pp 4–17.
9. 9.↵
   BioPhorum Operations Group. Biomanufacturing Technology Roadmap: Knowledge Management, 2017. BioPhorum Web site. https://www.biophorum.com/download/biomanufacturing-technology-roadmap-7-knowledge-management/ (accessed March 28, 2020).
10. 10.↵
    U.S. Food and Drug Administration. Drug Shortages: Root Causes and Potential Solutions, 2019. FDA Web site. https://www.fda.gov/drugs/drug-shortages/report-drug-shortages-root-causes-and-potential-solutions (accessed March 14, 2020).
11. 11.↵
    1. Lipa M.,
    2. Bruno S.,
    3. Thien M.,
    4. Guenard R.

    A Practical Approach to Managing Knowledge—A Case Study of the Evolution of Knowledge Management (KM) at Merck. Pharm. Eng. 2013, 33 (6), 94–104.

    OpenUrl
12. 12.↵
    Resource Engineering Inc. History of FMEAs. Quality Training Portal. https://qualitytrainingportal.com/resources/fmea-resource-center/fmea-history/ (accessed March 27, 2020).
13. 13.↵
    International Conference for Harmonisation, Quality Guideline Q9: Quality Risk Management. ICH: Geneva, 2005.
14. 14.↵
    1. Calnan N.,
    2. Lipa M. J.,
    3. Kane P. E.,
    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. In A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry; Calnan N., Lipa M. J., Kane P. E., Menezes J. C., Eds.; Taylor & Francis: Boca Raton, FL, 2017; pp 133–151.
15. 15.↵
    International Organization for Standardization, ISO 30401:2018 Knowledge Management Systems—Requirements. ISO: Geneva, 2018.
16. 16.↵
    1. Birkinshaw J.

    Why is Knowledge Management so Difficult? Bus. Strategy Rev. 2001, 12 (1), 11–18.

    OpenUrl
17. 17.↵
    1. Lipa M.,
    2. Kane P. E.,
    3. Greene A.

    Effective Knowledge Transfer during Biopharmaceutical Technology Transfer—How Well Do We Do? J. Validation Technol. 2019, 25 (4).
18. 18.↵
    BioPhorum Operations Group. A Test Case in CMC Business Processes from Late-Stage Development to Commercial Manufacturing, 2020. BioPhorum Web site. https://www.biophorum.com/download/a-test-case-in-cmc-business-processes-from-late-stage-development-to-commercial-manufacturing/ (ac-cessed May 31 2020).
19. 19.
    Preserve. Merriam-Webster Web site. https://www.merriam-webster.com/dictionary/preserve (accessed April 13, 2020).
20. 20.
    Transferred. Dictionary Web site. https://www.dictionary.com/browse/transferred (accessed April 13, 2020).
21. 21.
    Grow. Lexico Web site. https://www.lexico.com/en/definition/grow (accessed April 13, 2020)
22. 22.↵
    Define—Phase 1 (of 5) of Lean Six Sigma. GoLeanSixSigma Web site. https://goleansixsigma.com/define-phase-1-of-5-of-lean-six-sigma/ (accessed May 30, 2020).
23. 23.↵
    1. Page R.

    Hope Is Not a Strategy: The 6 Keys to Winning the Complex Sale; McGraw Hill Professional: New York, 2003.
24. 24.↵
    International Society for Pharmaceutical Engineering. Good Practice Guide: Technology Transfer, 3rd ed.; ISPE: Tampa, FL, 2018.
25. 25.↵
    Parenteral Drug Association Inc. Technical Report No. 65: Technology Transfer; Bethesda, MD, 2014.
26. 26.↵
    International Society for Pharmaceutical Engineering. Cultural Excellence Report; Bethesda, MD, 2017.
27. 27.↵
    1. Calnan N.,
    2. Lipa M. J.,
    3. Kane P. E.,
    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. E., Menezes J. C., Eds.; Taylor & Francis: Boca Raton, FL, 2017; pp 181–224.
28. 28.↵
    1. Gorman M. E.

    Types of Knowledge and Their Roles in Technology Transfer. J. Technol. Transfer 2002, 27 (3), 219–231.

    OpenUrl
29. 29.↵
    World Health Organization. Annex 7: WHO Guidelines on Transfer of Technology; WHO Technical Report Series No. 961; WHO: Geneva, 2011; 285–309.
30. 30.↵
    1. Gibson M.,
    2. Schmitt S.

    , Eds. Technology and Knowledge Transfer: Keys to Successful Implementation and Management, PDA-Davis Healthcare International Publishing: River Grove, IL, 2014.
31. 31.↵
    1. O’Dell C.,
    2. Hubert C.

    The New Edge in Knowledge. John Wiley & Sons, Inc: Hoboken, NJ; 2012.
32. 32.↵
    1. Dampney K.,
    2. Busch P.,
    3. Richards D.

    The Meaning of Tacit Knowledge. AJIS [Online]. 2002, 10 (1), https://doi.org/10.3127/ajis.v10i1.438 (accessed April 14, 2020).
33. 33.↵
    APQC. Introduction to Knowledge Management: KM Essentials: APQC: Houston, TX, 2018.
34. 34.↵
    1. Beardsley S. C.,
    2. Johnson B. C.,
    3. Manyika J. M.

    Competitive Advantage from Better Interactions. McKinsey Quarterly 2006, (2), 52–63.
35. 35.↵
    1. Drucker P. F.

    The Practice of Management, 1st ed.; Harper & Row: New York, 1954.
36. 36.↵
    ASQ. PDCA Cycle—What Is the Plan-Do-Check-Act Cycle? https://asq.org/quality-resources/pdca-cycle (accessed March 14, 2020).
37. 37.↵
    1. Kane P.,
    2. Lipa M.

    Advancing Knowledge Management (KM) as an ICH Q10 Enabler in the Biopharmaceutical Industry, TU Dublin Academic Press: Dublin, 2020.