A importância da validação de limpeza: os impactos trazidos pela RDC nº 301/19 e o futuro da indústria
Data
2022-02-01
Autores
Oldani, Fernanda de Lima 
Orientadores
Santos, Patrícia Lopes
Tipo
Trabalho de conclusão de curso
Título da Revista
ISSN da Revista
Título de Volume
Resumo
Na indústria farmacêutica, o setor da Garantia da Qualidade é essencial para garantir
que todos os produtos fabricados dentro da planta fabril estejam de acordo com os
padrões de qualidade exigidos pela Agência Nacional de Vigilância Sanitária
(ANVISA), portanto, durante todas as etapas do processo produtivo, as normas de
Boas Práticas de Fabricação (BPF), ditadas pela ANVISA, devem ser cumpridas. A
fim de cumprir todas as normas e especificações com extrema maestria, este setor
divide as suas obrigações em alguns subsetores entre qualificações, validações, entre
outros. Esses subsetores, em conjunto, regem as leis da qualidade da indústria.
Dentre todos os processos que existem dentro da Garantia de Qualidade, o trabalho
em questão traz uma discussão a respeito da validação de limpeza e todos os seus
desafios na indústria. A mesma pode ser definida como evidência documentada de
que um procedimento aprovado de limpeza que remove, reprodutivamente, os
resíduos de produtos anteriores, os resíduos dos agentes de limpeza e ainda reduz a
carga microbiana presente nos equipamentos a um nível abaixo do cientificamente
estabelecido como seguro para a contaminação dos produtos posteriores. Além disso,
o trabalho apresenta uma breve discussão a respeito do termo “Industria 4.0”. Como
conclusão, a partir do conjunto de informações obtidas ao longo do trabalho, foi
possível verificar que a validação de limpeza seguida da sanitização são processos
essenciais para a manutenção da higienização dos equipamentos e utensílios que
fazem parte da rota produtiva dentro da indústria farmacêutica. Os procedimentos de
limpezas precisam ser validados e monitorados para que as boas práticas de
fabricação sejam seguidas de maneira efetiva e a limpeza automatizada vem
ganhando cada vez mais foco nas indústrias.
In the pharmaceutical industry, the Quality Assurance sector is essential to ensure that all products manufactured within the manufacturing plant are in accordance with the quality standards required by the National Health Surveillance Agency (ANVISA), therefore, during all stages of the production process, the Good Manufacturing Practices (GMP) standards, dictated by ANVISA, must be met. In order to meet all the standards and specifications with extreme mastery, this sector divides its obligations in some subsectors between qualifications, validations, among others. These subsectors together govern the industry's quality laws. Among all the processes that exist within Quality Assurance, this paper brings a discussion about cleaning validation and all its challenges in the industry. It can be defined as documented evidence that an approved cleaning procedure reproducibly removes previous product residues, cleaning agent residues, and reduces the microbial load present in the equipment to a level below that scientifically established as safe for contamination of subsequent products. In addition, the paper presents a brief discussion of the term "Industry 4.0". As a conclusion, from the set of information obtained throughout the work, it was possible to verify that cleaning validation followed by sanitization are essential processes for the maintenance of the hygiene of equipment and utensils that are part of the production route within the pharmaceutical industry. The cleaning procedures need to be validated and monitored so that the good manufacturing practices are followed effectively and the automated cleaning has been gaining more and more focus in the industries.
In the pharmaceutical industry, the Quality Assurance sector is essential to ensure that all products manufactured within the manufacturing plant are in accordance with the quality standards required by the National Health Surveillance Agency (ANVISA), therefore, during all stages of the production process, the Good Manufacturing Practices (GMP) standards, dictated by ANVISA, must be met. In order to meet all the standards and specifications with extreme mastery, this sector divides its obligations in some subsectors between qualifications, validations, among others. These subsectors together govern the industry's quality laws. Among all the processes that exist within Quality Assurance, this paper brings a discussion about cleaning validation and all its challenges in the industry. It can be defined as documented evidence that an approved cleaning procedure reproducibly removes previous product residues, cleaning agent residues, and reduces the microbial load present in the equipment to a level below that scientifically established as safe for contamination of subsequent products. In addition, the paper presents a brief discussion of the term "Industry 4.0". As a conclusion, from the set of information obtained throughout the work, it was possible to verify that cleaning validation followed by sanitization are essential processes for the maintenance of the hygiene of equipment and utensils that are part of the production route within the pharmaceutical industry. The cleaning procedures need to be validated and monitored so that the good manufacturing practices are followed effectively and the automated cleaning has been gaining more and more focus in the industries.