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Article CommentaryCommentary

Words Matter: A Commentary and Glossary of Definitions for Microbiological Quality

Gerald McDonnell, Hal Baseman and Lena Cordie-Bancroft
PDA Journal of Pharmaceutical Science and Technology November 2021, 75 (6) 553-570; DOI: https://doi.org/10.5731/pdajpst.2021.012706
Gerald McDonnell
1Microbiological Quality & Sterility Assurance, Johnson & Johnson;
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  • For correspondence: gmcdonne@its.jnj.com
Hal Baseman
2ValSource, Inc; and
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Lena Cordie-Bancroft
3Qualitas Professional Services, LLC
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References

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    International Conference for Harmonisation. Quality Guideline Q9: Quality Risk Management. ICH: Geneva, 2005. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html (accessed Sep 15, 2021).
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    European Commission. Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 Concerning the Making Available on the Market and Use of Biocidal Products; Doc. #02012R0528-20210610; OJ 2012, L 67. European Commission: Brussels, 2012.
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    U.S. Pharmacopeial Convention. General Chapter <1111> Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use. In USP 43–NF 38. USP: Rockville, MD, 2020; p 7819. www.usp.org (accessed August 24, 2021).
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PDA Journal of Pharmaceutical Science and Technology: 75 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 6
November/December 2021
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Words Matter: A Commentary and Glossary of Definitions for Microbiological Quality
Gerald McDonnell, Hal Baseman, Lena Cordie-Bancroft
PDA Journal of Pharmaceutical Science and Technology Nov 2021, 75 (6) 553-570; DOI: 10.5731/pdajpst.2021.012706

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Words Matter: A Commentary and Glossary of Definitions for Microbiological Quality
Gerald McDonnell, Hal Baseman, Lena Cordie-Bancroft
PDA Journal of Pharmaceutical Science and Technology Nov 2021, 75 (6) 553-570; DOI: 10.5731/pdajpst.2021.012706
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  • Article
    • Abstract
    • Introduction
    • Words Matter: A Harmonized Glossary Is Important
    • Glossary Development
    • Evolution of Existing Terms
    • Risk Management: An End-to-End Philosophy
    • Aseptic Processing
    • Controlled Environments
    • Critical
    • Contamination, Decontamination, and Disinfection
    • Sterile and Sterility, Assurance of Sterility, and Sterility Testing
    • Conclusion
    • Publisher's Note
    • Acknowledgments
    • Appendix 1. Glossary
    • References
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  • A Risk Based Approach for Pre-Use/Post-Sterilization Integrity Test Simulation During Bacterial Retention Testing as Part of the Process Specific Filter Validation of Sterilizing Grade Filters
  • Challenges and Solutions to Manufacturing of Low-Viscosity, Ultra-High Concentration IgG1 Drug Products: From Late Downstream Process to Final Fill Finish Processing
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