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6 de junho de 2011 6v6f1o A Anvisa definiu algumas regras para análises das petições de Certificação de Boas Práticas de Fabricação (CBPF) para as plantas de indústrias que produzem medicamentos, insumos farmacêuticos e produtos para a saúde, localizadas em outros países. Uma das mudanças determina que as inspeções internacionais para concessão da CBPF, que tenham ado pela aprovação da Diretoria Colegiada da Anvisa, não sofrerão alterações, nem mesmo de data.
Depois que as companhias receberem o comunicado da Anvisa sobre a data em que serão inspecionadas para obter a certificação CBPF, as empresas não poderão fazer mudanças em suas plantas industriais. O peticionamento para a certificação CBPF será cancelado quando a inspeção agendada não puder ser realizada, em atendimento a uma solicitação da empresa ou por qualquer outra motivo que fuja a competência da Anvisa.Quando o peticionamento é encerrado, por problemas que estão fora da governabilidade da Anvisa, a indústria deverá entrar com um novo pedido de inspeção na Agência.
Os dispositivos que regulamentam a certificação CBPF em inspeções internacionais estão contidos na Orientação de Serviço 001/2011, da Gerência-Geral de Inspeção e Controle de Insumos, Medicamentos e Produtos (GGIMP).
