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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 January 2023, 77 (1) 18-26; DOI: https://doi.org/10.5731/pdajpst.2022.012739
Annie Leahy
1Process Solutions, MilliporeSigma, Bedford and Burlington, MA; and
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  • For correspondence: annie.leahy@milliporesigma.com
Jennifer Juneau
2Pharmaceutical Research and Development, BioTherapeutics Pharmaceutical Sciences, Pfizer Inc., Andover, MA
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Kathleen Souza
1Process Solutions, MilliporeSigma, Bedford and Burlington, MA; and
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Corinne Miller
1Process Solutions, MilliporeSigma, Bedford and Burlington, MA; and
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Nhung Nguyen
1Process Solutions, MilliporeSigma, Bedford and Burlington, MA; and
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Herb Lutz
1Process Solutions, MilliporeSigma, Bedford and Burlington, MA; and
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Parag Kolhe
2Pharmaceutical Research and Development, BioTherapeutics Pharmaceutical Sciences, Pfizer Inc., Andover, MA
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Article Information

vol. 77 no. 1 18-26
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 
  • Published online February 6, 2023.

Article Versions

  • previous version (July 15, 2022 - 11:02).
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Copyright & Usage 
© PDA, Inc. 2023

Author Information

  1. Annie Leahy1,*,
  2. Jennifer Juneau2,
  3. Kathleen Souza1,
  4. Corinne Miller1,
  5. Nhung Nguyen1,
  6. Herb Lutz1 and
  7. Parag Kolhe2
  1. 1Process Solutions, MilliporeSigma, Bedford and Burlington, MA; and
  2. 2Pharmaceutical Research and Development, BioTherapeutics Pharmaceutical Sciences, Pfizer Inc., Andover, MA
  1. ↵* Corresponding Author: 400 Summit Dr, Burlington, MA 01803; E-mail: annie.leahy{at}milliporesigma.com
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PDA Journal of Pharmaceutical Science and Technology: 77 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 1
January/February 2023
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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 Jan 2023, 77 (1) 18-26; 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 Jan 2023, 77 (1) 18-26; DOI: 10.5731/pdajpst.2022.012739
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  • Final fill
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  • Validation

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