Evaluating the impact of periodic product review on pharmaceutical production process improvement: A case study
1 Universidade Castelo Branco, Faculty of Pharmacy. Santa Cruz Avenue, 1631 – Realengo, Rio de Janeiro – RJ, Brazil, 21710-255.
2 Universidade do Estado do Rio de Janeiro, campus Zona Oeste, UERJ-ZO. Manuel Caldeira de Alvarenga Avenue, 1203 - Inhoaíba, Rio de Janeiro - RJ, Brazil, 23070-200.
3 Terra Pharmacy Laboratory, Faculty of Pharmacy, Federal University of Bahia, Barão de Jeremoaba Street, 147, Ondina, Salvador – BA, Brazil, 40170-115.
4 Faculdade de Ciências Médicas, Universidade Estadual de Campinas. Albert Sabin Street, s/nº. Cidade Universitária "Zeferino Vaz", Campinas, SP, Brazil, 13083-894.
5 Didactic Laboratory of Practical Classes in Pharmaceutics, Faculty of Pharmacy, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Rio de Janeiro, RJ – Brazil, 21941-902.
Review Article
GSC Biological and Pharmaceutical Sciences, 2024, 27(03), 178–184.
Article DOI: 10.30574/gscbps.2024.27.3.0240
Publication history:
Received on 11 May 2024; revised on 19 June 2024; accepted on 22 June 2024
Abstract:
The aim of this study was to evaluate the impact of Periodic Product Review (PPR) on improvements in the production process of pharmaceuticals by statistically analyzing the in-process control of the parameters average weight by coating and hardness.
Methods. For this purpose, a case study was conducted in a pharmaceutical industry analyzing the statistical PPR data of a coated tablet from 2021 and 2022. Diagrams and tables based on probability and statistical theory were used for the analysis.
Results. The data analysis revealed that PPR was effective in helping to identify problems in the production process, which were then resolved. As a result, the production performance of this drug product was significantly improved, as evidenced by the reduction in the variability of analytical results and process performance indicators within the acceptable range.
Conclusion. The results of this work show that PPR is an important tool for ensuring the quality of pharmaceutical products. Statistical analysis of PPR data makes it possible to identify trends and patterns that may indicate the need for improvements in the production process.
Keywords:
Periodic Product Review; Statistical Process Control; Quality Assurance; Pharmaceutical Production
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Copyright © 2024 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0
