QUALITY BY DESIGN (QBD) AS A TOOL FOR OPTIMIZATION OF PHARMACEUTICAL PROCESSES.

Authors

  • Mariana Palmeira Bezerra Universidade Federal de São Paulo/Instituto de Ciências Ambientais, Químicas e Farmacêuticas/Departamento de Ciências Farmacêuticas/Rua São Nicolau, 210 Diadema, SP CEP 09913-030.
  • Leticia Norma Carpentieri Rodrigues Universidade Federal de São Paulo/Instituto de Ciências Ambientais, Químicas e Farmacêuticas/Departamento de Ciências Farmacêuticas/Rua São Nicolau, 210 Diadema, SP CEP 09913-030. http://orcid.org/0000-0002-3121-4357

DOI:

https://doi.org/10.14450/2318-9312.v29.e1.a2017.pp5-12

Keywords:

pharmaceutical processes, quality by design, process analytical techniques.

Abstract

The pharmaceutical industry is constantly evolving. The harmonization of production standards, with the aim of guaranteeing efficacy, safety and quality of medicines, is one of the greatest challenges. The concept of “Quality by design” (QbD) proposes a systematic approach, based on scientific knowledge and risk management associated with the manufacturing process. In this approach, quality is inversely proportional to variability. The implementation of the QbD concept is a promising tool for pharmaceutical production, since it allows the production of medicines by means of risk prediction, increasing the possibility of generating products with efficiency, safety and quality assured, together with the reduction of costs. The implementation of this concept requires not only new technologies, but the change in the concept of quality.

Author Biographies

Mariana Palmeira Bezerra, Universidade Federal de São Paulo/Instituto de Ciências Ambientais, Químicas e Farmacêuticas/Departamento de Ciências Farmacêuticas/Rua São Nicolau, 210 Diadema, SP CEP 09913-030.

Aluno de Graduação do curso de Farmácia da Universidade Federal de São Paulo (2010-2016).

Leticia Norma Carpentieri Rodrigues, Universidade Federal de São Paulo/Instituto de Ciências Ambientais, Químicas e Farmacêuticas/Departamento de Ciências Farmacêuticas/Rua São Nicolau, 210 Diadema, SP CEP 09913-030.

Professor Adjunto da Universidade Federal de São Paulo, Departamento de Ciencias Exatas e da Terra, Setor de Ciências Farmacêuticas. Atua na área de desenvolvimento farmacotécnico e tecnologia farmacêutica. Linha de Pesquisa: Desenvolvimento de Formas Farmacêuticas Sólidas, Sistemas Farmacêuticas e Pré-formulação.

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Published

2017-04-03

How to Cite

Bezerra, M. P., & Rodrigues, L. N. C. (2017). QUALITY BY DESIGN (QBD) AS A TOOL FOR OPTIMIZATION OF PHARMACEUTICAL PROCESSES. Infarma - Pharmaceutical Sciences, 29(1), 5–12. https://doi.org/10.14450/2318-9312.v29.e1.a2017.pp5-12

Issue

Vol. 29 No. 1 (2017)

Section

Review Article

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