GESTÃO DA QUALIDADE NA INDÚSTRIA FARMACÊUTICA: FALHAS OPERACIONAIS E ESTRATÉGIAS DE MELHORIA - UMA REVISÃO INTEGRATIVA

Quality management is fundamental in the pharmaceutical industry, as medicinal products must demonstrate quality, safety, and efficacy, while meeting regulatory requirements. Operational failures can compromise production processes and product quality, necessitating measures to prevent, identify, and correct them. This study aimed to analyze, through an integrative literature review, the primary operational failures in quality management in the pharmaceutical industry, as well as the tools used to control them. Searches were conducted across databases including PubMed, SciELO, the Virtual Health Library (Biblioteca Virtual em Saúde), and Google Scholar, covering publications from 2022 to 2026. The studies identified issues such as human error, contamination risks, process variability, documentation errors, data integrity problems, non-conformities, and difficulties in identifying root causes. Key strategies highlighted include risk management, Failure Mode and Effects Analysis (FMEA), Corrective and Preventive Actions (CAPA), Quality by Design (QbD), root cause analysis (RCA), Statistical Process Control, staff training, audits, and the review of Standard Operating Procedures (SOPs). The findings underscore the importance of prevention, professional training, and continuous monitoring. It is concluded that the integrated application of these strategies can help reduce operational failures and maintain the quality and safety of pharmaceutical products.