Interventions Risk Evaluation and Management in Aseptic Manufacturing - A Case Study

Hal Baseman; Subrata Chakraborty; Michael K Long

doi:10.5731/pdajpst.2020.012245

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Interventions Risk Evaluation and Management in Aseptic Manufacturing - A Case Study

Hal Baseman, Subrata Chakraborty and Michael K Long

PDA Journal of Pharmaceutical Science and Technology May 2022, pdajpst.2020.012245; DOI: https://doi.org/10.5731/pdajpst.2020.012245

Hal Baseman

1 Valsource;

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For correspondence: hbaseman@valsource.com

Subrata Chakraborty

2 GxPFont Consulting Group

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For correspondence: emailsubrato@gmail.com

Michael K Long

1 Valsource;

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For correspondence: mlong@valsource.com

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pdajpst.2020.012245

DOI

https://doi.org/10.5731/pdajpst.2020.012245

PubMed

35613741

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Received August 12, 2020
Accepted May 13, 2022
Published online May 25, 2022.

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Hal Baseman1 (hbaseman{at}valsource.com),
Subrata Chakraborty2,3 (emailsubrato{at}gmail.com) and
Michael K Long1 (mlong{at}valsource.com)

¹ Valsource;
² GxPFont Consulting Group

↵* Corresponding author; email: emailsubrato{at}gmail.com

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Interventions Risk Evaluation and Management in Aseptic Manufacturing - A Case Study

Hal Baseman, Subrata Chakraborty, Michael K Long

PDA Journal of Pharmaceutical Science and Technology May 2022, pdajpst.2020.012245; DOI: 10.5731/pdajpst.2020.012245

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Interventions Risk Evaluation and Management in Aseptic Manufacturing - A Case Study

Hal Baseman, Subrata Chakraborty, Michael K Long

PDA Journal of Pharmaceutical Science and Technology May 2022, pdajpst.2020.012245; DOI: 10.5731/pdajpst.2020.012245

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Keywords

Aseptic process simulation
Aseptic processing
Intervention
media fills
quaility risk management
Risk assessment

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