Investigating Aberrant Results in Microbiological Examination of Nonsterile Product Assays

Crystal Booth

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 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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vol. 74 no. 5 571-580

DOI

https://doi.org/10.5731/pdajpst.2019.010504

PubMed

32467174

Published By

Parenteral Drug Association (PDA)

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1079-7440

Online ISSN

1948-2124

History

Published online October 5, 2020.

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previous version (May 28, 2020 - 09:03).
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Crystal Booth

PSC Biotech, 700 Corporate Center Dr., Pomona, CA 91768

Corresponding Author: PSC Biotech, 700 Corporate Center Dr., Pomona, CA 91768, Telephone: 909.620.0757; E-mail: cbooth{at}biotech.com

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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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Keywords

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

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