Application of the FMEA tool to analyze notifications of technical complaints about liquid medicines in the context of Quality by Design
DOI:
https://doi.org/10.33448/rsd-v12i6.41992Keywords:
Quality by design; FMEA; Quality control; Pharmaceutical technology; ANVISA; Quality improvement.Abstract
Given the growth of the pharmaceutical industry in recent years, different approaches can be adopted in the design of drug manufacturing processes, aiming to obtain increasingly safer and more effective products. The use of different strategies and technologies is necessary to ensure the identification of all potential failure points and the optimization of the controls implemented in the manufacturing stages. In this context, the concept of Quality by Design (QbD), widely promoted by the Food and Drug Administration (FDA) and by the International Conference on Harmonization (ICH), has been highlighted in Brazil, as it consists of an approach based on the systematic development of products through the use of several tools, based on the management of quality risks allied to cost reduction, in order to promote the continuous improvement of the drug production chain. The study presented a quantitative analysis of the causes of potential failures notified by the official ANVISA website during the period from 2020 to 2022, through the evaluation of the RPN elaborated by the FMEA tool within the context of QbD. A total of 453 technical complaints were analyzed , being 71 complaints (15.7%) about liquid drugs, with approximately 77.5% referring to pharmacotechnical problems such as packaging, appearance and formulation. The QCD concept for risk management and manufacturing principles aims at reducing costs and implementing control strategies in the development of the process and formulation, which enable the gradual decrease in the number of technical complaints of these products, as well as the reduction of failures and human errors.
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