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Publication
Gestão de risco em qualidade :
| Name: | Description: | Size: | Format: | |
|---|---|---|---|---|
| 2.04 MB | Adobe PDF |
Authors
Abstract(s)
A autoridade regulamentar de medicamentos do Brasil – Agência Nacional de Vigilância Sanitária
(ANVISA) – tem vivenciado um processo de convergência regulatória nos últimos anos.
Nesse contexto, a ANVISA, através da participação em foros internacionais, como a International
Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
e o Pharmaceutical Inspection Co-operation Scheme (PIC/S), atualizou o marco legal referente
às Boas Práticas de Fabrico de medicamentos tornando-o semelhante aos das demais
autoridades participantes. A publicação da RDC N. 301 e Instruções Normativas, em 2019,
internalizou as diretrizes presentes nas guidelines de qualidade da ICH, as quais também estão
descritas nos guias da PIC/S. Dentre as novas diretrizes, destacam-se os conceitos do
Gerenciamento de Risco da Qualidade (ICH Q9) e do Sistema de Qualidade Farmacêutico (ICH
Q10) que passaram a ser necessários para garantir qualidade, segurança e eficácia aos
medicamentos a serem comercializados no país.
Por meio da avaliação de documentos denominados análises de risco das lacunas regulatórias,
produzidos por algumas empresas fabricantes de medicamentos do Brasil, foi possível traçar um
panorama acerca da forma de incorporação e utilização do conceito de Gerenciamento de Risco
da Qualidade (GRQ) e perceber o grau de maturidade do Sistema de Qualidade Farmacêutico
(SQF) no que concerne à gestão dos riscos dos itens autodiagnosticados como ausentes ou não
conformes às diretrizes de Boas Práticas de Fabrico nacionais e internacionais.
Após a avaliação de documentos produzidos por vinte e quatro (24) empresas, verificou-se que
as indústrias farmacêuticas brasileiras ainda carecem de melhor entendimento sobre os conceitos
e vantagens do GRQ e do SQF, a utilização das ferramentas de gestão do risco e da perceção
sobre a importância da Gestão do Conhecimento. Também, percebeu-se que a autoridade
regulamentar necessita de ferramentas de apoio para melhor uso e promoção do conhecimento
sobre o GRQ.
The regulatory authority for medicines in Brazil – National Health Surveillance Agency (ANVISA) – has been experiencing a process of regulatory convergence in recent years. In this context, ANVISA, through participation in international forums, such as the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), updated the legal framework referring to the Good Manufacturing Practices for medicines becoming it common to the other participating authorities. The publication of Resolution RDC N. 301 and Normative Instructions, in 2019, internalized the ICH quality guidelines, which are also described in the PIC/S guides. Among the new guidelines, the concepts of Quality Risk Management (ICH Q9) and the Pharmaceutical Quality System (ICH Q10) have become necessary to ensure quality, safety and efficacy for drugs to be marketed in the country. Through the evaluation of the risk analysis of regulatory gaps, produced by some drug manufacturing companies in Brazil, it was possible to draw an overview of the incorporation and use of the concept of Quality Risk Management (QRM) and to perceive the degree of maturity of the Pharmaceutical Quality System (PQS) regarding risk management of the items that were self-diagnosed as absent or non-compliant with national and international Good Manufacturing Practices guidelines. After evaluating these documents produced by twentyfour (24) companies, it was found that Brazilian pharmaceutical industries still lack a better understanding of the concepts and advantages of QRM and PQS, the use of risk management tools and perception about the importance of Knowledge Management. Also, it was noticed that the regulatory authority needs supporting tools for better use and promotion of knowledge about the QRM.
The regulatory authority for medicines in Brazil – National Health Surveillance Agency (ANVISA) – has been experiencing a process of regulatory convergence in recent years. In this context, ANVISA, through participation in international forums, such as the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), updated the legal framework referring to the Good Manufacturing Practices for medicines becoming it common to the other participating authorities. The publication of Resolution RDC N. 301 and Normative Instructions, in 2019, internalized the ICH quality guidelines, which are also described in the PIC/S guides. Among the new guidelines, the concepts of Quality Risk Management (ICH Q9) and the Pharmaceutical Quality System (ICH Q10) have become necessary to ensure quality, safety and efficacy for drugs to be marketed in the country. Through the evaluation of the risk analysis of regulatory gaps, produced by some drug manufacturing companies in Brazil, it was possible to draw an overview of the incorporation and use of the concept of Quality Risk Management (QRM) and to perceive the degree of maturity of the Pharmaceutical Quality System (PQS) regarding risk management of the items that were self-diagnosed as absent or non-compliant with national and international Good Manufacturing Practices guidelines. After evaluating these documents produced by twentyfour (24) companies, it was found that Brazilian pharmaceutical industries still lack a better understanding of the concepts and advantages of QRM and PQS, the use of risk management tools and perception about the importance of Knowledge Management. Also, it was noticed that the regulatory authority needs supporting tools for better use and promotion of knowledge about the QRM.
Description
Tese de mestrado, Regulação e Avaliação do Medicamento e Produtos de Saúde, 2022, Universidade de Lisboa, Faculdade de Farmácia.
Keywords
Gerenciamento de risco da qualidade Sistema de qualidade farmacêutico Avaliação de risco Ferramentas de gerenciamento de risco Inspeção Regulação farmacêutica Boas práticas de fabrico Teses de mestrado - 2022