Quality Indicators in Pharmaceutical Industry

Authors

  • Ana Débora Nunes Pinheiro Universidade Federal Fluminense Instituto de Química Programa de Pós-Graduação em Química Outeiro de São João Batista, s/n Campus Valonguinho - Centro, Niterói, Rio de Janeiro CEP 24020-141

DOI:

https://doi.org/10.14450/2318-9312.v29.e4.a2017.pp364-370

Keywords:

pharmaceutical industry, quality indicators, quality systems

Abstract

The quality of pharmaceutical industrial processes - and how to achieve it - is a theme of great interest on the pharmaceutical industry, especially in what concerns its standardization. With the standardization of the practices and the normatization of the good manufacturing guidelines, a concern it started, also from the government, with what would be quality in the pharmaceutical industry and how to achieve it. This work aims to gather main guidelines and practices used as quality indicators in the pharmaceutical industry. Therefore, it was selected 21 review and research articles obtained through a search on the online databases, as well reference guidelines from international organizations, such as World Health Organization (WHO), Food and Drug Administration (FDA) and International Council for Harmonization of Technical Requirements for  Pharmaceuticals for Human Use (ICH). After organizing and studying the selected material, the quality practices currently used in the pharmaceutical industry was described, such as quality risk management,  quality by design, corrective and preventive actions, lean manufacturing, total quality system and ISO series. Although a complete and updated published regimentation about quality indicators and practices in the pharmaceutical industry is already available, the publications lack specific information and practical experiences on the implementation of these quality systems, being hard to exemplify the positive influence of these strategies on the management of pharmaceutical industries.

Author Biography

Ana Débora Nunes Pinheiro, Universidade Federal Fluminense Instituto de Química Programa de Pós-Graduação em Química Outeiro de São João Batista, s/n Campus Valonguinho - Centro, Niterói, Rio de Janeiro CEP 24020-141

Farmacêutica pela Universidade Federal do Ceará; Mestre em Ciências pela Faculdade Ciências Farmacêuticas de Ribeirão Preto da Universidade de São Paulo; Especialista em Gestão Industrial Farmacêutica pela Universidade Estácio de Sá; Doutoranda em Química pela Universidade Federal Fluminense.

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Published

2017-12-18

How to Cite

Nunes Pinheiro, A. D. (2017). Quality Indicators in Pharmaceutical Industry. Infarma - Pharmaceutical Sciences, 29(4), 364–370. https://doi.org/10.14450/2318-9312.v29.e4.a2017.pp364-370

Issue

Vol. 29 No. 4 (2017)

Section

Technical Note

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