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Research ArticleResearch

Comparison of Different Calculation Approaches for Defining Microbiological Control Levels Based on Historical Data

Oliver Gordon, Marcel Goverde, James Pazdan, Alexandra Staerk and David Roesti
PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 383-398; DOI: https://doi.org/10.5731/pdajpst.2015.01050
Oliver Gordon
1Immunobiology Laboratory, Cancer Research UK London Research Institute, London UK;
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Marcel Goverde
3MGP Consulting GmbH, Binningen, Switzerland; and
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James Pazdan
4Pharma Development, Novartis Pharmaceuticals Corporation, Hanover, NJ, USA
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Alexandra Staerk
2Microbiological Quality Control Unit, Novartis Pharma Stein AG, Stein, Switzerland;
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David Roesti
2Microbiological Quality Control Unit, Novartis Pharma Stein AG, Stein, Switzerland;
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  • For correspondence: david.roesti@novartis.com
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PDA Journal of Pharmaceutical Science and Technology: 69 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 3
May/June 2015
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Comparison of Different Calculation Approaches for Defining Microbiological Control Levels Based on Historical Data
Oliver Gordon, Marcel Goverde, James Pazdan, Alexandra Staerk, David Roesti
PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 383-398; DOI: 10.5731/pdajpst.2015.01050

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Comparison of Different Calculation Approaches for Defining Microbiological Control Levels Based on Historical Data
Oliver Gordon, Marcel Goverde, James Pazdan, Alexandra Staerk, David Roesti
PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 383-398; DOI: 10.5731/pdajpst.2015.01050
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  • Environmental Monitoring
  • Historical data
  • Alert level

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