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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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Article Information

vol. 75 no. 6 553-570
DOI 
https://doi.org/10.5731/pdajpst.2021.012706
PubMed 
34845101

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online November 29, 2021.

Copyright & Usage 
© PDA, Inc. 2021

Author Information

  1. Gerald McDonnell1,*,
  2. Hal Baseman2 and
  3. Lena Cordie-Bancroft3
  1. 1Microbiological Quality & Sterility Assurance, Johnson & Johnson;
  2. 2ValSource, Inc; and
  3. 3Qualitas Professional Services, LLC
  1. ↵*Corresponding Author: Johnson & Johnson, Building 930 East, 1000 Route 202 South, Raritan, NJ 08869; Telephone: +1-908-927-2865; E-mail: gmcdonne{at}its.jnj.com
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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
  • References
  • Info & Metrics
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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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  • Microbiological quality
  • Sterility assurance

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