Revision of Viable Environmental Monitoring in a Development Pilot Plant based on Quality Risk Assessment: A Case Study

Ildikó no Ziegler; Judit no Borbély-Jakab; Lilla no Lilla Sugó; Réka J. Kovács

doi:10.5731/pdajpst.2016.007096

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Revision of Viable Environmental Monitoring in a Development Pilot Plant based on Quality Risk Assessment: A Case Study

Ildikó no Ziegler, Judit no Borbély-Jakab, Lilla no Lilla Sugó and Réka J. Kovács

PDA Journal of Pharmaceutical Science and Technology January 2017, pdajpst.2016.007096; DOI: https://doi.org/10.5731/pdajpst.2016.007096

Ildikó no Ziegler

1 Validation Department, Gedeon Richter Plc.;

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For correspondence: mohazihu@yahoo.com

Judit no Borbély-Jakab

2 Microbiological and Hygiene Laboratory, Gedeon Richter Plc;

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Lilla no Lilla Sugó

3 On leave from Quality Assurance Department, Gedeon Richter Plc;

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Réka J. Kovács

4 Microbiological and Hygienic Laboratory, Gedeon Richter Plc, Dorog

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PDA Journal of Pharmaceutical Science and Technology

Vol. 79, Issue 2

March/April 2025

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Revision of Viable Environmental Monitoring in a Development Pilot Plant based on Quality Risk Assessment: A Case Study

Ildikó no Ziegler, Judit no Borbély-Jakab, Lilla no Lilla Sugó, Réka J. Kovács

PDA Journal of Pharmaceutical Science and Technology Jan 2017, pdajpst.2016.007096; DOI: 10.5731/pdajpst.2016.007096

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Revision of Viable Environmental Monitoring in a Development Pilot Plant based on Quality Risk Assessment: A Case Study

Ildikó no Ziegler, Judit no Borbély-Jakab, Lilla no Lilla Sugó, Réka J. Kovács

PDA Journal of Pharmaceutical Science and Technology Jan 2017, pdajpst.2016.007096; DOI: 10.5731/pdajpst.2016.007096

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Keywords

Cleanroom
Environmental Monitoring
Good Mnaufacturing Practice
quality risk management

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