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

Ildikó Ziegler, Judit Borbély-Jakab, Lilla Sugó and Réka J. Kovács
PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 234-244; DOI: https://doi.org/10.5731/pdajpst.2016.007096

Article Information

vol. 71 no. 3 234-244
DOI 
https://doi.org/10.5731/pdajpst.2016.007096
PubMed 
28089966
Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online May 26, 2017.

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Copyright & Usage 
© PDA, Inc. 2017

Author Information

  1. Ildikó Ziegler1,*,
  2. Judit Borbély-Jakab2,
  3. Lilla Sugó3,# and
  4. Réka J. Kovács4
  1. 1Validation Department, Dorog Site, Gedeon Richter Plc, Dorog, Hungary;
  2. 2Microbiological and Hygiene Laboratory, Gedeon Richter Plc, Budapest, Hungary;
  3. 3On leave from Quality Assurance Department, Gedeon Richter Plc, Budapest, Hungary; and
  4. 4Microbiological and Hygienic Laboratory, Gedeon Richter Plc, Dorog, Hungary
  1. ↵* Corresponding Author: Validation Department, Dorog Site, Gedeon Richter Plc, Esztergomi út 27, Dorog H-2510, Hungary; e-mail: mohazihu{at}yahoo.com

  • ↵# Present address: Egis, 1106 Budapest, Keresztúri út 30-38.

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Revision of Viable Environmental Monitoring in a Development Pilot Plant Based on Quality Risk Assessment: A Case Study
Ildikó Ziegler, Judit Borbély-Jakab, Lilla Sugó, Réka J. Kovács
PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 234-244; DOI: 10.5731/pdajpst.2016.007096
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