Validação de processo: como garantir a qualidade dos alimentos e medicamentos?

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Realidade na indústria farmacêutica desde o final da década de 1990, a validação de processo é uma das etapas mais importantes dentro da cadeia de produção farmacêutica e de serviços logísticos do setor, mas ainda existem muitas dúvidas a respeito do assunto.

Por ser criteriosa e exigir conhecimento de diversos assuntos, normas e padrões, pode parecer desafiador realizar a validação, mas com as informações e orientações necessárias, é possível executá-la com sucesso.

Explicamos agora, em detalhes, o que é a validação de processo, como ela funciona, como a tecnologia pode auxiliar e otimizar a validação, seus principais benefícios e também os impactos na qualidade de medicamentos e serviços logísticos. Confira abaixo e ótima leitura!

Entenda agora o que é validação de processo

Quando falamos em validação de processos, estamos tratando de uma série de estudos, voltados a comprovar que um processo, atividade, equipamento ou procedimento realmente funcionam e que é possível reproduzir o processo de forma segura.

Sua função é garantir que os processos realizados pela indústria farmacêutica serão executados de forma segura e pré-determinada, de acordo com normas e padrões, podendo ser reproduzido e utilizado em diversas situações.

Saiba como ela funciona

Em geral, são utilizados três tipos distintos de validação de processos:

  • validação concorrente: visa a aprovação a ser obtida durante a produção de produtos voltados à venda;
  • validação retrospectiva: visa demonstrar que o produto final não apresenta falhas e que os procedimentos foram executados conforme esperado;
  • validação prospectiva: considerada a forma de validação ideal, é realizada durante o estágio de desenvolvimento do produto e, em geral, executada no lote piloto.

Também é possível que ocorra a chamada validação de requalificação, que é executada após o prazo de validade do estudo expirar ou quando existe mudança na fórmula, no procedimento ou em qualquer ponto do processo.

Veja como a tecnologia otimiza a validação de processo

Por otimizar o acompanhamento, a execução de testes e a análise de resultados, a tecnologia auxilia muito nos estudos de validação de processos, já que permite compreender dados, informações e resultados de forma mais clara, objetiva e inteligente.

Além disso, por meio da aplicação de ferramentas tecnológicas, como a inteligência artificial, é possível desenvolver modelos preditivos baseados nas informações existentes, auxiliando na formulação de hipóteses de estudo e no planejamento do estudo de validação em si.

Conheça os principais benefícios da validação

Além de garantir a conformidade com as normas e regulamentos, que é uma obrigação legal, a validação de processos também oferece um diferencial competitivo interessante, já que a empresa pode assegurar a qualidade dos produtos que oferta ao mercado, garantindo a integridade dos consumidores.

Entenda o impacto na qualidade de medicamentos e serviços logísticos

Como é possível perceber, a validação de processos é um estudo fundamental para o desenvolvimento da indústria farmacêutica, por isso, deve ser entendido de forma clara. Além disso, é importante para que as normas e regimentos legais sejam seguidos e respeitados.

O que você achou de conhecer mais detalhes a respeito da validação de processo, compreender como funciona, como a tecnologia pode otimizar a validação de processos, seus principais benefícios e seu impacto na qualidade de medicamentos e serviços logísticos? Se deseja contar com suporte especializado para a validação de processos, entre em contato conosco!

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