Quality Risk Management: Putting GMP Controls First

References

1. 1.↵
   Quality Risk Management (ICH Q9), International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, November 9, 2005, available at www.ich.org.
2. 2.↵
   The Rules Governing Medicinal Products in the European Union, Vol. 4, Part III; published by the European Commission. Available at http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm.
3. 3.↵
   U.S. Department of Health and Human Services. Food and Drug Administration, Guidance for Industry. Process Validation: General Principles and Practices; January 2011, Rev. 1. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070336.pdf.
4. 4.↵
   1. Stamatis D. H.

   . Failure Mode and Effect Analysis: FMEA from Theory to Execution, 2nd ed.; ASQ Quality Press: Milwaukee, 2003.
5. 5.↵
   1. Vesper J. L.

   . Risk Assessment and Risk Management in the Pharmaceutical Industry, Davis Healthcare International Publishing, 2006.
6. 6.↵
   1. McDermott R. E.,
   2. Mikulak R. J.,
   3. Beauregard M. R.

   . The Basics of FMEA; Quality Resources Press: New York, 1996.
7. 7.↵
   1. Greenfield M. A.

   . Risk Assessment and Management, Tools and Applications (Presentation), NASA Office of Safety and Mission Assurance (no date). http://www.ece.mtu.edu/faculty/rmkieckh/aero/NASA-RA-tools-sli.PDF (accessed October 1, 2007).
8. 8.↵
   1. Kleinfeld V. A.,
   2. Dunn C. W

   . United States vs. Bristol Labs. Inc., Federal Food Drug and Cosmetic Act: Judicial and Administrative Record, 1938–1949, pp 310– 314.
9. 9.↵
   1. Madsen R. E.,
   2. Cherris R. T.,
   3. Shabushnig J. G.,
   4. Hunt D. G.

   . Visible particulates in injections—a history and a proposal to revise USP general chapter injections. Pharmacopeial Forum 2009, 35 (5),1383– 1387.

   OpenUrl
10. 10.↵
    1. Goseva-Popstojanova K.,
    2. Hassan A.,
    3. Guedem A.,
    4. Abdelmoez W.,
    5. Nassar D. E. M.,
    6. Ammar H.,
    7. Mili A

    . Architectural-level risk analysis using UML. IEEE Transactions on Software Engineering 2003, 29 (10), 946– 960.

    OpenUrl
11. 11.↵
    1. Greenfield M. A.

    . Normal Accident Theory: The Changing Face of NASA and Aerospace; NASA Office of Safety and Mission Assurance, presentation; Hagerstown, MD, November 17, 1998. Available at http://www.hq.nasa.gov/office/codeq/accident/accident.pdf.
12. 12.↵
    Center for Drug Evaluation and Research, FDA, Guidance for Industry: PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, September 2004, available at: http://www.fda.gov/.
13. 13.↵
    Fault Tree Analysis (FTA), IEC 61025, Edition 2.0, 12/2006, International Electronic Commission, Geneva, Switzerland. Available at http://www.iec.ch.
14. 14.↵
    Analysis Techniques for System Reliability: Procedure for Failure Mode and Effects Analysis (FMEA), IEC 60812, Edition 2.0, 1/2006, International Electronic Commission, Geneva, Switzerland. Available at http://www.iec.ch.
15. 15.↵
    U.S. Military Standard No. MIL-STD-1629A. Procedures for Performing a Failure Mode, Effects and Criticality Analysis (FMECA), U.S. Department of Defense, Washington, DC, 1980.
16. 16.↵
    Application of Hazard Analysis and Critical Control Point (HACCP) Methodology in Pharmaceuticals; Annex 7, WHO Technical Report Series 908, World Health Organization, 2003. Available at http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/.
17. 17.↵
    Recommended International Code of Practice: General Principles of Food Hygiene Cac/rcp 1-1969, rev. 3-1997, amd., 1999. [Note: This document is from the Codex Alimentarius Commission and the FAO/WHO Food Standards Programme.].
18. 18.↵
    ISPE Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities, Vol. 5, Commissioning and Validation, 2001. http://www.ispe.org/cs/baseline_guides.
19. 19.↵
    GAMP: A Risk-Based Approach to Compliant GxP Computerised Systems, ISPE 2008, http://www.ispe.org.
20. 20.↵
    1. Klink J.

    Von der Risikoanalyse zum Risikomanagement-Prozess. PharmInd 2010, 72 (3),409– 416.

    OpenUrl
21. 21.↵
    1. O'Donnell K.,
    2. Greene A.

    . Failure modes: simple strategies for improving qualitative quality risk management exercises during qualification, validation and change control activities. J. Validation Technol. 2007, 13 (2),100– 112.

    OpenUrl
22. 22.↵
    1. O'Donnell K.

    . The Development of a Quality Risk Management Solution Designed To Facilitate Compliance with the Risk-Based Qualification, Validation & Change Control GMP Requirements of the EU. Ph.D. Dissertation, submitted to the Dublin Institute of Technology, 2007.
23. 23.↵
    1. Claycamp H. G.

    Risk, Uncertainty, and Process Analytical Technology, J. Process Anal. Tech. 2006, 42 (3),8– 13.

    OpenUrl
24. 24.↵
    1. O'Donnell K.

    Strategies for addressing the problems of subjectivity and uncertainty in quality risk management exercises: Part I: the role of human heuristics. J. Validation Technol. 2010, 16 (3)
25. 25.↵
    1. Schnettler R.,
    2. Müller I,
    3. Wawetschek C.

    . GMP-Konferenz: Risikomanagement, Sterilfertigung, Compliance, PharmInd 2011, 73 (1),144– 150.

    OpenUrl
26. 26.↵
    From discussions with GMP inspectors from over 20 PIC/S member countries at various PIC/S Expert Circle meetings on quality risk management, 2007–2011.
27. 27.↵
    1. Johanning H.,
    2. Dahlgaard A.

    . Does quality risk management add value? Pharmaceutical Technology Europe 2007, 19 (12)
28. 28.↵
    1. Tidswell E. C.

    Bacterial adhesion: considerations within a risk-based approach to cleaning validation. PDA J. Pharm. Sci. Technol. 2005, 59 (1),10– 32.

    OpenUrlAbstract/FREE Full Text
29. 29.↵
    1. Schmidt M. W.

    The use and misuse of FMEA in risk analysis. Medical Device and Diagnostic Industry 2004, 26 (3),56– 61.

    OpenUrl
30. 30.↵
    1. Kmenta S.,
    2. Ishii K

    . Scenario-based failure modes and effects analysis using expected cost. J. Mech. Des. 2004, 126 (6),1027– 1035.

    OpenUrl
31. 31.↵
    1. Rhee J.,
    2. Ishii K

    . Using cost based FMEA to enhance reliability and serviceability. Advanced Engineering Informatics 2003, 17 (3–4),79– 188.

    OpenUrl
32. 32.↵
    1. Bowles J. B.

    . An assessment of RPN prioritization in a failure modes effects and criticality analysis, Reliability and Maintainability Symposium, 2003. Annual, pp: 380– 386., 2003, available at http://ieeexplore.ieee.org, posted online: 2003-02-28.
33. 33.↵
    International Standard ISO 31000, Risk Management—Principles and Guidelines, First Edition 2009-11-15, (ISO Reference number ISO 31000:2009(E)), Published in Ireland by the National Standards Authority of Ireland (NSAI) on October 15, 2009.
34. 34.↵
    Pharmaceutical Development, (ICH Q8), International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, November 9th, 2005, available at www.ich.org.
35. 35.↵
    1. O'Donnell K.,
    2. Greene A

    . A risk management solution designed to facilitate risk-based qualification, validation and change control activities within GMP and pharmaceutical regulatory compliance environments in the EU: Parts I and II. J. GXP Compliance 2006, 10 (4),12– 25.

    OpenUrl
36. 36.↵
    1. Zwitkovits M.

    . Process Translation: From Drug Synthesis to API Technology; Ph.D. Dissertation, currently under review at the School of Pharmacy, University of Vienna, for publication in 2012.
37. 37.↵
    1. O'Donnell K.

    . Practical Strategies for Improving Quality Risk Management Activities in GMP Environments; CMC Strategy Forum, CASSS Quality Risk Management Conference; Bethesda, MD, July 27–28, 2009.