Demonstrating Pharmaceutical Quality System Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction

Reference

1. 1.↵
   Quality Guideline Q10: Pharmaceutical Quality System. ICH, 2010. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html (accessed October 2017).
2. 2.↵
   Quality Guideline Q8(R2): Pharmaceutical Development. ICH, 2009. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf (accessed October 2017).
3. 3.↵
   Quality Guideline Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities). ICH, 2012. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html (accessed October 2017).
4. 4.↵
   Eudralex Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Chapter 1. Pharmaceutical Quality System. September 2012. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/vol4-chap1_2013-01_en.pdf (accessed October 2017).
5. 5.↵
   Guidance for Industry PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. September 2004. https://www.fda.gov/downloads/drugs/guidances/ucm070305.pdf (accessed October 2017).
6. 6.↵
   ICH Q12 Final Concept Paper: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. Endorsed by ICH Steering Committee 9 September 2014. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q12/Q12_Final_Concept_Paper_July_2014.pdf (accessed November 2017).
7. 7.↵
   See HPRA Annual Reports 2005–2016. Available at www.hpra.ie.
8. 8.↵
   1. O'Donnell K.

   , QRM in the GMP Environment: Ten Years On … Are Medicines Any Safer Now? A Regulator's Perspective. J. Valid. Technol. 2015, 21 (4), 9.

   OpenUrl
9. 9.↵
   1. Ramnarine E.,
   2. Busse U.,
   3. Chassant F.,
   4. Edwards J.,
   5. O'Donnell K.,
   6. Jornitz M.,
   7. Munk M.,
   8. Seymour M.,
   9. Simianu M.,
   10. Skeens L.,
   11. Vinther A.

   PDA Points to Consider: Technical Product Lifecycle Management Pharmaceutical Quality System Effectiveness for Managing Post-Approval Changes. PDA J. Pharm. Sci. Technol. 2017, 71 (3), 252–258.

   OpenUrlFREE Full Text
10. 10.↵
    1. Morgan M. G.,
    2. Henrion M.

    Uncertainty—A Guide to Dealing with Uncertainty in Quantitative Risk and Policy Analysis; Cambridge University Press: New York, 1990.
11. 11.↵
    1. Morgan M. G.,
    2. Morris S. C.,
    3. Henrion M.,
    4. Amaral D. A. L.,
    5. Rish W. R.

    ; Technical Uncertainty in Quantitative Policy Analysis: A Sulphur Air Pollution Example. Risk Analysis 1984, 4 (3), 201–216.

    OpenUrlCrossRefWeb of Science
12. 12.↵
    1. Mullen T. M.

    Understanding and Supporting the Process of Probabilistic Estimation, PhD Dissertation, Carnegie Mellon University, Pittsburgh, 1986.
13. 13.↵
    1. Rasmussen N. C.

    The Application of Probabilistic Risk Assessment Techniques to Energy Technologies. Ann. Rev. Energy 1981, 6 (1), 123–138.

    OpenUrlCrossRef
14. 14.↵
    1. Stamatelatos M.

    Probabilistic Risk Assessment—What Is It and Why Is It Worth Performing? NASA Office of Safety and Mission Assurance, May 4, 2000, available from www.hq.nasa.gov (accessed November 28, /2007).
15. 15.↵
    1. Greenfield M. A.

    The Inherent Values of Probabilistic Risk Assessment (Presentation), June 19, 2001, NASA Office of Safety and Mission Assurance, available from http://www.hq.nasa.gov/office/codeq/risk/risk_archive.htm (accessed November 29, /2007).
16. 16.↵
    1. Kaplan S.,
    2. Garrick B. J.

    “On the Quantitative Definition of Risk.” Risk Analysis 1981, 1 (1), 11–27.

    OpenUrlCrossRef
17. 17.↵
    1. Kmenta S.,
    2. Ishii K.

    Scenario-Based Failure Modes and Effects Analysis Using Expected Cost. Journal of Mechanical Design 2004, 126 (6), 1027–1035.

    OpenUrl
18. 18.↵
    1. Schmidt M. W.

    The Use and Misuse of FMEA in Risk Analysis. Medical Device & Diagnostic Industry 2004, 26, 56–61.

    OpenUrl
19. 19.↵
    1. Rhee J.,
    2. Ishii K.

    Using Cost Based FMEA To Enhance Reliability and Serviceability. Advanced Engineering Informatics 2003, 17 (3-4), 179–188.

    OpenUrlCrossRef
20. 20.↵
    1. Bowles J. B.

    An Assessment of RPN Prioritization in a Failure Modes Affects and Criticality Analysis. Reliability and Maintainability Symposium 2003, 380–386; available at http://ieeexplore.ieee.org (posted online: 2003-02-28).
21. 21.↵
    1. O'Donnell K.,
    2. Zwitkovits M.,
    3. Greene A.,
    4. Calnan N.

    Quality Risk Management—Putting GMP Controls First. PDA J. Pharm. Sci. Technol. 2012, 66 (3), 243–261.

    OpenUrlAbstract/FREE Full Text
22. 22.↵
    1. Kahneman D.,
    2. Tversky A.

    Subjective Probability: A Judgement of Representativeness. Cognitive Psychology 1972, 3, 430–354.

    OpenUrlCrossRefWeb of Science
23. 23.↵
    1. Kahneman D,
    2. Slovic P,
    3. Tversky A

    1. Lichtenstein S.,
    2. Fischhoff B.,
    3. Phillips L. D.

    Calibration of Probabilities: The State of the Art to 1980. In Judgement under Uncertainty: Heuristics and Biases, Kahneman D, Slovic P, Tversky A, Eds.; Cambridge University Press: New York, 1982.
24. 24.↵
    1. Keller A. Z.

    Perception and Quantification of Risk. ISPRA courses, Reliability and Data, JRC ISPRA, 21020, Italy, 1984.
25. 25.↵
    1. Fischhoff B.,
    2. Slovic P.,
    3. Lichtenstein S.

    Fault Trees: Sensitivity of Estimated Failure Probabilities to Problem Representation. J. Exp. Psychol.—Human Perception Perf. 1978, 4, 330–444.

    OpenUrl
26. 26.↵
    1. Kahneman D.,
    2. Tversky A.

    “On the Psychology of Prediction.” Psychological Review 1973, 80 (4), 237–251.

    OpenUrlCrossRefWeb of Science
27. 27.↵
    1. Goldberg L. R.

    The Effectiveness of Clinicians' Judgements: The Diagnosis of Organic Brain Damage from the Bender-Gestalt Test. Journal of Consulting Psychologists 1959, 23, 23–33.

    OpenUrl
28. 28.↵
    1. Wallsten T. S.,
    2. Budescu D. V.,
    3. Rapoport A.,
    4. Zwick R.,
    5. Forsyth B.

    Measuring the Vague Meaning of Probability Terms. Journal of Experimental Psychology: General 1985, 115, 348–365.

    OpenUrl
29. 29.↵
    1. Brier G. W.

    Verification of Forecasts Expressed in Terms of Probability. Monthly Weather Review 1950, 78, 1–3.

    OpenUrlCrossRef
30. 30.↵
    1. Faust D.

    Declarations versus Investigations: The Case for the Special Reasoning Abilities and Capabilities of the Expert Witness in Psychology/Psychiatry. Journal of Psychiatry & Law 1985, 13 (1–2), 33–59.

    OpenUrl
31. 31.↵
    1. Hoch S. J.

    Availability and Interference in Predictive Judgement. Journal of Experimental Psychology: Learning, Memory and Cognition 1984, 10 (4), 649.

    OpenUrlCrossRefWeb of Science
32. 32.↵
    U.S. Nuclear Regulatory Commission. An Approach for Using Probabilistic Risk Assessment in Risk-Informed Decisions on Plant-Specific Changes to the Licensing Basis, NRC Regulatory Guide No. 1.174, Revision 1, November 2002.
33. 33.↵
    1. Hickman J. W.,
    2. et al

    ., PRA Procedures Guide – A Guide to the Performance of Probabilistic Risk Assessments for Nuclear Power Plants. American Nuclear Society, NUREG/CR-2300, Vols. 1 and 2, January 1983.
34. 34.↵
    American Society of Mechanical Engineers. Standard for Probabilistic Risk Assessment for Nuclear Power Plant Applications, ASME RA-S-2002, April 2002.
35. 35.↵
    1. MacDonald J. A.,
    2. Small M. J.,
    3. Morgan M. J.

    Explosion Probability of Unexploded Ordnance. Risk Analysis 2008, 28 (4), 825–841.

    OpenUrlPubMed
36. 36.↵
    1. Coburn J.,
    2. Weddle G.

    Risk-Based Regulation, Learning from the Experience of Others. BioProcess International 2006, September, 22–28.
37. 37.↵
    1. Coburn J.,
    2. Levinson S. H.,
    3. Weddle G.

    A Precedent for Risk-Based Regulation. Pharmaceutical Engineering 2005, July/August, 40–90.
38. 38.↵
    1. Kunreuther H.,
    2. Novemsky N.,
    3. Kahneman K.

    Making Low Probabilities Useful. Journal of Risk and Uncertainty 2001, 23 (2), 103–120.

    OpenUrlCrossRefWeb of Science
39. 39.↵
    1. O'Keeffe D.,
    2. Campbell C.,
    3. O'Donnell K.

    A Spectrum of Importance—Challenging the Concept of ‘Critical/Non-critical’ in Qualification and Validation Activities. J. Valid. Technol. 2016, 22 (1).