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Análise de Risco para melhoria contínua da qualidade na produção de medicamentos estéreis
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Recentemente a procura de produtos penicilínicos tem vindo aumentar, desta forma,
respondendo às necessidades do mercado, os Laboratórios Atral efetuaram uma nova expansão
na Unidade de processo assético de pós para injetáveis. Esta nova unidade fabril necessita de
ser validada, qualificada e devidamente monitorizada.
Os objetivos deste trabalho são definir e melhorar as estratégias de prevenção de perda de
Qualidade do produto e a Validação do respetivo Processo de Fabrico da nova unidade de
produção. Sendo esta uma unidade de processamento assético, um dos principais riscos a
considerar é a contaminação microbiológica do produto. Consequentemente foi efetuada uma
avaliação de risco à possibilidade de contaminação do produto e de alteração das características
de qualidade do mesmo.
Foram identificados como os riscos mais elevados associados à contaminação microbiológica a
limpeza e montagem de equipamentos em classe A e as entradas de material pelas antecâmaras
de materiais. Foram aplicadas medidas de mitigação de risco, estas incluem ensaios de
avaliação de esterilidade de superfícies e a realização da Validação de Processos de limpeza e
desinfeção. Posteriormente procedeu-se a uma nova avaliação dos diversos riscos e conclui-se
que a aplicação das medidas de mitigação de risco foi eficaz na redução da maioria dos riscos
alvo de um nível de risco médio para um nível baixo.
Foi acompanhada também a validação do processo de fabrico que comprova a qualidade do
produto segundo as especificações do mesmo, que é necessário para a sua introdução no
mercado. Obtiveram-se resultados conformes para três lotes de validação de forma a validar o
processo de fabrico cujas principais variáveis avaliadas foram o doseamento (massa unitária,
composição e homogeneidade entre doses), esterilidade, entre outros. Estudou-se também a
capacidade do processo na fase de enchimento (massa unitária) que indicou que o processo é
capaz de produzir dentro dos limites especificados.
Recently the demand for penicillin products has been increasing, thus, and to attend to the market needs Laboratórios Atral made an expansion in the Penicilin Unit that is dedicated to the aseptic production of powders to injections. There is the need of validating, qualifying and properly monitoring this new industrial unit. The goals of this thesis are to define and improve the product quality loss’ prevention strategies and the Validation of the respective Manufacturing Process. Being this an Aseptic Processing Unit, one of the main risks to consider is the microbiological contamination of the product. Consequently, it was made a risk evaluation to the possibility of product’s microbiological contamination and the risk of product’s quality characteristics’ alteration. The cleaning and assemble of Class A equipment and the entry of material through the material antechambers were identified as the highest risks associated with microbiological contamination. Risk mitigation actions were applied, including surfaces sterility evaluation assays and the Validation of cleaning and disinfecting procedures. Later it was made a new risk evaluation and was concluded that the applying of these actions was effective on the reduction of most of the targeted risks from a medium to a low level. The Manufacturing Process’ Validation was followed, which evidences the product’s quality according to product specifications which is one of the requirements to get authorization to release the product to the market. Acceptable results were obtained for three validation batches, being enough to validate the manufacturing process, in which the main evaluated variables were the dosing (unit mass, composition e doses homogeneity), the sterility, among others. The process capacity in the filling stage was also studied and indicated that the manufacturing process is capable of production between the specified limits.
Recently the demand for penicillin products has been increasing, thus, and to attend to the market needs Laboratórios Atral made an expansion in the Penicilin Unit that is dedicated to the aseptic production of powders to injections. There is the need of validating, qualifying and properly monitoring this new industrial unit. The goals of this thesis are to define and improve the product quality loss’ prevention strategies and the Validation of the respective Manufacturing Process. Being this an Aseptic Processing Unit, one of the main risks to consider is the microbiological contamination of the product. Consequently, it was made a risk evaluation to the possibility of product’s microbiological contamination and the risk of product’s quality characteristics’ alteration. The cleaning and assemble of Class A equipment and the entry of material through the material antechambers were identified as the highest risks associated with microbiological contamination. Risk mitigation actions were applied, including surfaces sterility evaluation assays and the Validation of cleaning and disinfecting procedures. Later it was made a new risk evaluation and was concluded that the applying of these actions was effective on the reduction of most of the targeted risks from a medium to a low level. The Manufacturing Process’ Validation was followed, which evidences the product’s quality according to product specifications which is one of the requirements to get authorization to release the product to the market. Acceptable results were obtained for three validation batches, being enough to validate the manufacturing process, in which the main evaluated variables were the dosing (unit mass, composition e doses homogeneity), the sterility, among others. The process capacity in the filling stage was also studied and indicated that the manufacturing process is capable of production between the specified limits.
Descrição
Palavras-chave
Indústria farmacêutica Análise de risco Validação Qualificação Processo Assético Garantia de Qualidade