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Review ArticleReview

Investigating Aberrant Results in Microbiological Examination of Nonsterile Product Assays

Crystal Booth
PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 571-580; DOI: https://doi.org/10.5731/pdajpst.2019.010504
Crystal Booth
PSC Biotech, 700 Corporate Center Dr., Pomona, CA 91768
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References

  1. 1.↵
    U.S. Pharmacopeial Convention, General Chapter <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. In USP 42–NF 37, USP: Rockville, MD, 2019.
  2. 2.↵
    Council of Europe, Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests, Chapter 2.6.12. In European Pharmacopoeia (Ph. Eur.), 9th Edition, Council of Europe: Strasbourg, France, 2017.
  3. 3.↵
    Ministry of Health Labour and Welfare of Japan, General Tests, Processes and Apparatus—4.05 Microbiological Examination of Non-sterile Products. In The Japanese Pharmacopoeia, 17th Edition (English Version), MHLW: Tokyo, 2016.
  4. 4.↵
    U.S. Pharmacopeial Convention, General Chapter <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. In USP 42–NF 37, USP: Rockville, MD, 2019.
  5. 5.↵
    Council of Europe, Microbiological Examination of Nonsterile Products: Tests for Specified Micro-organisms, Chapter EP 2.6.13. In European Pharmacopoeia (Ph. Eur.), 9th Edition, Council of Europe: Strasbourg, France, 2017.
  6. 6.↵
    U.S. Food and Drug Administration, 21 CFR Part 211–Current Good Manufacturing Practice for Finished Pharmaceuticals. FDA Web site https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211. (accessed June 17, 2019).
  7. 7.↵
    U.S. Pharmacopeial Convention, General Chapter <1111> Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use. In USP 42–NF 37, USP: Rockville, MD, 2019.
  8. 8.↵
    International Council for Harmonisation, Quality Guideline Q6A: Decision Trees 6 and 8. ICH Web site. https://database.ich.org/sites/default/files/Q6A_Decision_Tree.pdf (accessed Sept 20, 2019).
  9. 9.↵
    Pharmaceutical Microbiology Manual, 2014. FDA Web site. https://www.fda.gov/files/about%20fda/published/Pharmaceutical-Microbiology-Manual.pdf (accessed Sept 20, 2019).
  10. 10.↵
    Parenteral Drug Association Inc. Technical Report No. 67: Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices, and Cosmetics; Bethesda, MD, 2014.
  11. 11.↵
    U.S. Pharmacopeial Convention, General Chapter <60> Microbiological Examination of Nonsterile Products—Tests for Burkholderia cepacia Complex. Pharmacopeial Forum [Online] 2018, 44, 5. http://www.usppf.com/pf/pub/index.html (accessed on Sept 20, 2019).
  12. 12.↵
    U.S. Food and Drug Administration, Guidance for Industry: Investigating Out-of-Specification Test Results for Pharmaceutical Production. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2006.
  13. 13.↵
    1. Sutton S.
    Successful Microbiological Investigations. Am. Pharm. Rev. [Online] 2011. https://www.americanpharmaceuticalreview.com/Featured-Articles/37190-Successful-Microbiological-Investigations/ (accessed June 18, 2019).
  14. 14.↵
    1. Carmody J.
    7 Steps to Properly Navigate an Event Investigation. Pharmaceutical Online [Online] 2017. https://www.pharmaceuticalonline.com/doc/steps-to-properly-navigate-an-event-investigation-0001 (accessed June 17, 2019).
  15. 15.↵
    U.S. Pharmacopeial Convention, General Chapter <1117> Microbiological Best Laboratory Practices. In USP 42–NF 37, USP: Rockville, MD, 2019.
  16. 16.↵
    Cause Analysis Tools. ASQ Web site. https://asq.org/quality-resources/root-cause-analysis/tools (accessed June 17, 2019).
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PDA Journal of Pharmaceutical Science and Technology: 74 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 5
September/October 2020
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Investigating Aberrant Results in Microbiological Examination of Nonsterile Product Assays
Crystal Booth
PDA Journal of Pharmaceutical Science and Technology Sep 2020, 74 (5) 571-580; DOI: 10.5731/pdajpst.2019.010504

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Investigating Aberrant Results in Microbiological Examination of Nonsterile Product Assays
Crystal Booth
PDA Journal of Pharmaceutical Science and Technology Sep 2020, 74 (5) 571-580; DOI: 10.5731/pdajpst.2019.010504
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  • Article
    • Abstract
    • Overview of the Microbial Limits Test
    • Performing Phase 1 of an OOS Investigation
    • Performing Phase 2 of an OOS Investigation
    • Finalizing the Investigation
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Keywords

  • Nonsterile
  • Out of specification
  • Investigation
  • Root cause
  • Microbial enumeration
  • Specified microorganisms
  • USP <61>
  • USP <62>

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