Application of Quality Tools to solve a quality deviation in the pharmaceutical industry: a case study

Authors

  • Thais Santos Amorim Universidade Cruzeiro do Sul. Localizado na Avenida Regente Feijó, 1295 - Vila Regente Feijó, São Paulo - SP, Brasil. CEP: 03342-000. http://orcid.org/0000-0002-8350-1147
  • Luís Henrique Garcia-Amoedo Universidade Cruzeiro do Sul. Localizado na Avenida Regente Feijó, 1295 - Vila Regente Feijó, São Paulo - SP, Brasil. CEP: 03342-000. http://orcid.org/0000-0002-8706-0991

DOI:

https://doi.org/10.14450/2318-9312.v33.e4.a2021.pp345-351

Keywords:

broken tablets, hardness test, pharmaceutical industry, quality

Abstract

Currently, due to the great competition among pharmaceutical companies, the demand for more quality, safety and effi cient products has been increasing, generating the need for processes that are more robust and a qualifi ed team. However, quality deviations can occur during the production process and the cause of this event must be identifi ed and solved in order to avoid repeating mistakes. The objective of this study is to demonstrate  through a case study the practical use of quality tools to identify and solve a quality deviation of broken pills in a pharmaceutical industry. For the organization, data evaluation and the identifi cation of the root cause of this deviation, the quality tools of Pareto Diagram, Control Chart, Check List  Sheet and Ishikawa Diagram were used. After data evaluation, it was possible to conclude that the breakage of the tablets is related to the low result of the hardness test, and then, it was suggested to the company to manufacture the next batches seeking hardness close to or greater than 200 N, according to the product's history. Therefore, the quality tools proved to be essential for an effective assessment of the quality deviation.

Author Biographies

Thais Santos Amorim, Universidade Cruzeiro do Sul. Localizado na Avenida Regente Feijó, 1295 - Vila Regente Feijó, São Paulo - SP, Brasil. CEP: 03342-000.

Departamento do curso de Farmácia da Universidade Cruzeiro do Sul.

Farmacêutica pela Universidade Cruzeiro do Sul (2020) e biomédica pela Universidade Cidade de São Paulo (2017).

Tem experiência na indústria farmacêutica, com ênfase em produção, qualidade, pesquisa e desenvolvimento de produtos.

Luís Henrique Garcia-Amoedo, Universidade Cruzeiro do Sul. Localizado na Avenida Regente Feijó, 1295 - Vila Regente Feijó, São Paulo - SP, Brasil. CEP: 03342-000.

Departamento do curso de Farmácia da Universidade Cruzeiro do Sul.

Farmacêutico pelas Faculdades Oswaldo Cruz (1992), nutricionista pela Universidade Nove de Julho (2008), mestre em Ciências dos Alimentos pela Universidade de São Paulo (1999) e doutor em Fármacos e Medicamentos pela Universidade de São Paulo (2004). Atualmente é professor na Universidade Cruzeiro do Sul. Tem experiência na área de Farmácia, com ênfase em Produção e Controle de Qualidade de medicamentos, cosméticos e correlatos.

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Published

2021-12-31

How to Cite

Amorim, T. S., & Garcia-Amoedo, L. H. (2021). Application of Quality Tools to solve a quality deviation in the pharmaceutical industry: a case study. Infarma - Pharmaceutical Sciences, 33(4), 345–351. https://doi.org/10.14450/2318-9312.v33.e4.a2021.pp345-351

Issue

Vol. 33 No. 4 (2021)

Section

Original article

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