Interventions Risk Evaluation and Management in Aseptic Manufacturing

Hal Baseman; Subrata Chakraborty; Michael A. Long

doi:10.5731/pdajpst.2020.012245

Research ArticleTechnology/Application

Interventions Risk Evaluation and Management in Aseptic Manufacturing

Hal Baseman, Subrata Chakraborty and Michael A. Long

PDA Journal of Pharmaceutical Science and Technology November 2022, 76 (6) 485-496; DOI: https://doi.org/10.5731/pdajpst.2020.012245

Hal Baseman

1ValSource, Inc., 918A Horseshoe Pike, Downingtown, PA 19335; and

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Subrata Chakraborty

2GxPFont Consulting Group, Margao, Goa-403601, India.

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For correspondence: subrata.chakraborty@gxpfont.com

Michael A. Long

1ValSource, Inc., 918A Horseshoe Pike, Downingtown, PA 19335; and

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vol. 76 no. 6 485-496

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

Published online December 2, 2022.

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previous version (May 25, 2022 - 06:04).
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Hal Baseman¹,
Subrata Chakraborty^2,* and
Michael A. Long¹

¹ValSource, Inc., 918A Horseshoe Pike, Downingtown, PA 19335; and
²GxPFont Consulting Group, Margao, Goa-403601, India.

↵*Corresponding author: GxPFont Consulting Group, Margao, Goa-403601, India; Telephone: +91 91673 00445; E-mail: subrata.chakraborty{at}gxpfont.com

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Interventions Risk Evaluation and Management in Aseptic Manufacturing

Hal Baseman, Subrata Chakraborty, Michael A. Long

PDA Journal of Pharmaceutical Science and Technology Nov 2022, 76 (6) 485-496; DOI: 10.5731/pdajpst.2020.012245

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Interventions Risk Evaluation and Management in Aseptic Manufacturing

Hal Baseman, Subrata Chakraborty, Michael A. Long

PDA Journal of Pharmaceutical Science and Technology Nov 2022, 76 (6) 485-496; DOI: 10.5731/pdajpst.2020.012245

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Keywords

Aseptic processing
Aseptic process simulation
Media fill
Intervention
quality risk management
Risk assessment

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