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

doi:10.5731/pdajpst.2016.007286

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@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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vol. 72 no. 3 317-331

DOI

https://doi.org/10.5731/pdajpst.2016.007286

PubMed

29444996

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Parenteral Drug Association (PDA)

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1079-7440

Online ISSN

1948-2124

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Published online June 18, 2018.

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previous version (February 14, 2018 - 18:16).
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Cleyton Lage Andrade*,
Miguel Angel De La O Herrera and
Elezer Monte Blanco Lemes

Bio-Manguinhos/Fiocruz, Instituto de Tecnologia em Imunobiológicos, Rio de Janeiro, Brasil

↵* Corresponding Author: Cleyton Lage Andrade, Av. Brasil, 4365, Manguinhos, Rio de Janeiro, 21040-900, Brasil. Telephone: +552138829551 or +552138827153; e-mail: cleyton.lage{at}bio.fiocruz.br.

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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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