Proposta de um manual de boas práticas de fabricação para indústrias de produtos de higiene pessoal, perfumes e cosméticos

Abstract

The methods of developing, manufacturing, and controlling Personal Hygiene, Perfumes, and Cosmetics (PHPC) products have undergone several changes in recent years. The Local Health Authority (ANVISA) has developed Norms and Resolutions for the segment that have contributed to the improvement of industrial processes, such as manufacturing, production, and quality control processes. In contrast, companies have been concerned that their activities are aligned with legal requirements. Specifically related to the production, the major sanitary and regulatory framework for the segment was the creation of Good Manufacturing Practices (GMP), known as RDC n⁰ 48/2013. ANVISA requires PHPC companies to follow and implement GMP standards and guidelines. Since Brazil has presented a growing number of industries in the segment, especially small companies that are in the process of migrating from artisanal production to production on an industrial scale, and the fact that access and understanding of the requirements imposed by the aforementioned RDC may not be easy to understand, it became necessary to develop a practical solution to this question. The current project proposes a Manual of Good Manufacturing Practices for PHPC Industries só that representatives of the segment, especially the small companies, can take advantage of it according to their particularities, provided that the authorial citation is respected. After reading and understanding RDC n⁰ 48/2013 and other pertinent resolutions, a critical analysis methodology was adopted for the construction of this project. Each item of the regulatory document was considered for the development of the structure of the GMP Manual, giving special attention to those that referred to standardization or related to the decisive steps to ensure the quality of the product. In addition, 12 standard operating procedures and tables were created for filling in and controlling activities, which will be available by companies. Some procedures and controls not required by Health Authorit assist companies in aligning with the resolution’s requirements. The proposal concludes that it is possible to write a GMP Manual for PHPC industries in an editable and easy-to-understand format. Since the GMP Manual is one of the requirements for obtaining the sanitary license and legal authorization for manufacturing, the small company that decides to develop its Manual becomes much more competitive since it will need to adopt several controls for the delivery of the product, guaranteeing quality, standardization, and consumer safety.