QUALITY BY DESIGN (QBD) AS A TOOL FOR OPTIMIZATION OF PHARMACEUTICAL PROCESSES.
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.
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PDF (Português (Brasil))DOI: http://dx.doi.org/10.14450/2318-9312.v29.e1.a2017.pp5-12
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Copyright (c) 2017 Mariana Palmeira Bezerra, Leticia Norma Carpentieri Rodrigues
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Infarma - Ciências Farmacêuticas
ISSN - 2318-9312 (Versão eletrônica)
ISSN - 0104-0219 (Versão impressa)
Conselho Federal de Farmácia - CFF
SHIS QI 15 Lote "L" - Lago Sul - Brasília - DF
CEP: 71635-615 - Fone: (61)3878-8751
e-mail:infarma@cff.org.br
Diretoria
Walter da Silva Jorge João, Presidente do Conselho Federal de Farmácia
Lenira da Silva Costa, Vice-Presidente do Conselho Federal de Farmácia
João Samuel de Morais Meira, Tesoureiro do Conselho Federal de Farmácia
Luiz Gustavo de Freitas Pires, Secretário-Geral do Conselho Federal de Farmácia