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Research ArticleTechnology/Application

A Model of Risk Analysis in Analytical Methodology for Biopharmaceutical Quality Control

Cleyton Lage Andrade, Miguel Angel De La O Herrera and Elezer Monte Blanco Lemes
PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 317-331; DOI: https://doi.org/10.5731/pdajpst.2016.007286
Cleyton Lage Andrade
Bio-Manguinhos/Fiocruz, Instituto de Tecnologia em Imunobiológicos, Rio de Janeiro, Brasil
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  • For correspondence: cleyton.lage{at}bio.fiocruz.br
Miguel Angel De La O Herrera
Bio-Manguinhos/Fiocruz, Instituto de Tecnologia em Imunobiológicos, Rio de Janeiro, Brasil
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Elezer Monte Blanco Lemes
Bio-Manguinhos/Fiocruz, Instituto de Tecnologia em Imunobiológicos, Rio de Janeiro, Brasil
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PDA Journal of Pharmaceutical Science and Technology: 72 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 3
May/June 2018
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A Model of Risk Analysis in Analytical Methodology for Biopharmaceutical Quality Control
Cleyton Lage Andrade, Miguel Angel De La O Herrera, Elezer Monte Blanco Lemes
PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 317-331; DOI: 10.5731/pdajpst.2016.007286

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A Model of Risk Analysis in Analytical Methodology for Biopharmaceutical Quality Control
Cleyton Lage Andrade, Miguel Angel De La O Herrera, Elezer Monte Blanco Lemes
PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 317-331; DOI: 10.5731/pdajpst.2016.007286
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Keywords

  • HACCP
  • Biopharmaceutical
  • Quality control
  • Residual Cellular DNA
  • Quality Risk Management
  • Analytical Methodology
  • Quality by Design

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