Qualificação de fornecedores dentro de uma indústria farmacêutica de Minas Gerais

Abstract

The pharmaceutical industry is fundamental to public health, requiring strict good practices to guarantee the safety and efficacy of medicines. Qualifying suppliers plays a crucial role in this process, ensuring that all stages of production meet the highest standards of quality and regulatory compliance. Therefore this study aims to discuss the importance of qualifying manufacturers and suppliers in the pharmaceutical industry, emphasizing the necessity of ensuring supply chain integrity and compliance with Good Manufacturing Practices (GMP). GMP is critical in maintaining a consistent standard of quality and adherence to current regulations. The methodology employed by the pharmaceutical industry under study encompasses four phases: selection, qualification, periodic evaluation, and, if necessary, disqualification. These phases are applicable to manufacturers and suppliers of inputs such as APIs, excipients, packaging materials, as well as service providers and carriers. The qualification process varies depending on the type of manufacturer, supplier, or service provided. Furthermore, this study addresses the qualification of manufacturers/suppliers of packaging materials, transporters, service providers, and third-party manufacturers, each with their own specific qualification protocols. Annual periodic assessments are conducted to ensure ongoing compliance of suppliers, with disqualification occurring if requirements are not met. Audits are performed to verify adherence to GMP, accompanied by reports and action plans formulated to address any non-conformities. The qualification of manufacturers and suppliers in the pharmaceutical industry constitutes a pivotal process in safeguarding product quality and safety.