Application of FMEA tool to analyze notifications of technical complaints of solid dosage forms in the context of Quality by Design
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Abstract
The quality control in pharmaceutical industries has been gradually improved with the implementation of new strategies and technologies, in order to make it possible to obtain increasingly effective and safe products. With the advent of the Quality by Design (QbD) concept, the production of medicines started to be optimized by delimiting the quality parameters of the products from the initial stages of development and formulation planning based on the characteristics of the active pharmaceutical ingredient, aiming defect prevention and continuous improvement of the production chain. Therefore, the present study constitutes a quantitative analysis of notifications of irregularities in solid medicines published on the National Health Surveillance Agency (ANVISA) official website during the period from 2017 to 2019, using the Failure Mode Analysis and Effects (FMEA) methodology in QbD context. Of the 421 notifications of irregular pharmaceutical products analyzed, 28.5% corresponded to technical complaints and, of this total, 60.0% were related to solid medicines. After evaluating the data, it was found that approximately 80.0% of the non-conformities found were related to aspect, dissolution, packaging, dosing and purity. Thus, it can be inferred that the QbD is an efficient strategy for the management of risks related to production, aiming at cost reduction and implementation of strategies that allow the gradual reduction in the number of technical complaints of these products.
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