Self-assessment model for pharmaceutical companies based on Good Manufacturing Practices for pharmaceuticals in Brazil: a multicriteria approach

a multicriteria approach

Authors

  • Alexandre Nunes Pontifical Catholic University of Rio de Janeiro
  • Maria Fatima Ludovico de Almeida Pontifical Catholic University of Rio de Janeiro
  • Daniel Lousada Pontifical Catholic University of Rio de Janeiro

DOI:

https://doi.org/10.21014/actaimeko.v15i3.2036

Keywords:

Good Manufacturing Practices, pharmaceutical sector, self-assessment model, multicriteria decision-making methods, RDC 658/2022, Brazil

Abstract

This study presents a novel self-assessment model for evaluating organizational compliance capabilities within Brazilian pharmaceutical companies regarding the Resolution RDC 658/2022 requirements established by the National Health Surveillance Agency (Anvisa) aligned with the World Health Organization's Good Manufacturing Practices (GMP) for pharmaceutical products. The research methodology comprised a systematic literature review and documentary analysis spanning 2010-2023, followed by the development of an analytical framework integrating the Analytic Hierarchy Process (AHP) for weighting the regulatory requirements of the aforementioned Resolution. The model's empirical validation was conducted through implementation at a Brazilian pharmaceutical company, evaluating its organizational compliance capabilities vis-à-vis the RDC 658/2022 requirements. Importance-Performance Analysis (IPA) was subsequently employed to prioritize areas that require enhanced regulatory compliance. The primary contribution of this study is a comprehensive self-assessment framework that provides pharmaceutical companies with robust decision-making support for visa certification processes. Empirical validation demonstrated the model's effectiveness in identifying critical compliance gaps and prioritizing improvement initiatives. This methodological advancement strengthens the interface between health regulatory authorities and pharmaceutical companies, potentially enhancing the effectiveness of Brazil’s regulatory system

Author Biographies

Alexandre Nunes, Pontifical Catholic University of Rio de Janeiro

Mr. Nunes holds a Bachelor's degree in Chemistry from the Federal Rural University of Rio de Janeiro (1997), a Master's in Metrology from PUC-Rio, and specializations in Health Surveillance - Pharmaceuticals and Business Logistics. He currently serves as Industrial/Quality Assurance Manager at A Química Santa Marina SA. His expertise includes regulatory affairs, GMP legislation for pharmaceutical ingredients and medicines, quality systems, laboratory control, and quality auditing according to WHO, ICH, and FDA guidelines.

Daniel Lousada , Pontifical Catholic University of Rio de Janeiro

Dr. Louzada is currently a professor in PUC-Rio's Graduate Program in Metrology. He holds a BSc in Physics (UERJ, 2002), MSc in Metrology (2006), PhD in Mechanical Engineering (PUC-Rio, CAPES 7 - 2013), and completed his Post-Doctoral research in Metrology (PUC-Rio, CAPES PNPD, 2019). His multidisciplinary expertise includes applied mechanics, sensor development, non-destructive testing, artificial intelligence, and photovoltaic systems. He conducts research at CBPF since 2021.

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Published

2026-08-18

Issue

Vol. 15 No. 3 (2026)

Section

Research Papers

License

Copyright (c) 2026 Alexandre Nunes, Maria Fatima Ludovico de Almeida, Daniel Lousada

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