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A Quality by Design Approach to Microbial Retention Validation

Annie Leahy, Jennifer Juneau, Kathleen Souza, Corinne Miller, Nhung Nguyen, Herb Lutz and Parag Kolhe
PDA Journal of Pharmaceutical Science and Technology July 2022, pdajpst.2022.012739; DOI: https://doi.org/10.5731/pdajpst.2022.012739
Annie Leahy
1 MilliporeSigma;
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Jennifer Juneau
2 Pfizer Inc
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Kathleen Souza
1 MilliporeSigma;
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Corinne Miller
1 MilliporeSigma;
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Nhung Nguyen
1 MilliporeSigma;
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Herb Lutz
1 MilliporeSigma;
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Parag Kolhe
2 Pfizer Inc
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Article Information

pdajpst.2022.012739
DOI 
https://doi.org/10.5731/pdajpst.2022.012739
PubMed 
35840346

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Received January 28, 2022
  • Accepted July 1, 2022
  • Published online July 15, 2022.

Article Versions

  • You are currently viewing a previous version of this article (July 15, 2022 - 11:02).
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Copyright & Usage 
Copyright © 2022, Parenteral Drug Association

Author Information

  1. Annie Leahy1,3 (annie.leahy{at}milliporesigma.com),
  2. Jennifer Juneau2 (jennifer.juneau{at}pfizer.com),
  3. Kathleen Souza1 (kathleen.souza{at}milliporesigma.com),
  4. Corinne Miller1 (corinne.miller{at}milliporesigma.com),
  5. Nhung Nguyen1 (nhung.nguyen{at}milliporesigma.com),
  6. Herb Lutz1 (herb.lutz{at}milliporesigma.com) and
  7. Parag Kolhe2 (parag.kolhe{at}pfizer.com)
  1. 1 MilliporeSigma;
  2. 2 Pfizer Inc
  1. ↵* Corresponding author; email: annie.leahy{at}milliporesigma.com

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PDA Journal of Pharmaceutical Science and Technology: 79 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
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A Quality by Design Approach to Microbial Retention Validation
Annie Leahy, Jennifer Juneau, Kathleen Souza, Corinne Miller, Nhung Nguyen, Herb Lutz, Parag Kolhe
PDA Journal of Pharmaceutical Science and Technology Jul 2022, pdajpst.2022.012739; DOI: 10.5731/pdajpst.2022.012739

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A Quality by Design Approach to Microbial Retention Validation
Annie Leahy, Jennifer Juneau, Kathleen Souza, Corinne Miller, Nhung Nguyen, Herb Lutz, Parag Kolhe
PDA Journal of Pharmaceutical Science and Technology Jul 2022, pdajpst.2022.012739; DOI: 10.5731/pdajpst.2022.012739
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Keywords

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  • Quality by Design
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  • Validation

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