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Análise de tendências no Sistema de Tratamento de Água para Fins Farmacêuticos
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O presente estudo tem como principal objetivo o estabelecimento de novos Limites de
Alerta para os parâmetros analisados no Sistema de Tratamento de Águas para Fins Farma-
cêuticos. As recentes diretrizes das Boas Práticas de Fabrico (GMPs) exigem que os Limites de
Alerta sejam estabelecidos através do tratamento dos dados gerados no processo, acompa-
nhado por uma monitorização regular do sistema a níveis químicos e microbiológicos.
Foram estudados os parâmetros do Sistema de Tratamento de Águas durante os anos
de 2021 e 2022, através do uso de ferramentas básicas de Qualidade e de Controlo Estatístico
do Processo. Extraíram-se os dados do controlo diário realizado diretamente ao sistema, de
análises químicas e microbiológicas de periodicidade mensal e, ainda, de análises diárias da
água de cada linha de produção.
A Análise de Tendências permitiu avaliar o comportamento natural do processo e respe-
tivas tendências, assim como as causas de variação associadas. Durante o período de estudo,
foi efetuada uma alteração ao Sistema de Tratamento de Águas, que implicou uma mudança
de tendência em vários parâmetros, nomeadamente do Cloro e pH, e ainda uma diminuição
da dispersão dos resultados. Foram revistos vinte limites de Alerta, em parâmetros cujos limites
de especificação se encontravam desajustados e impediam uma análise rigorosa do processo,
como o TOC e da Condutividade. Foram também definidos sete Limites de Ação para os parâ-
metros de controlo diário direto, onde os limites anteriores não se enquadravam com a ten-
dência do processo. Os novos Limites de Alerta estabelecidos são mais estreitos, permitindo
uma monitorização rigorosa do sistema, com maior capacidade de resposta e ação, conforme
o exigido pelas recentes diretrizes GMP.
The main objective of this study is to establish new Alert Limits for the parameters ana- lyzed in the Water Treatment System for Pharmaceutical Purposes. Recent Good Manufactur- ing Practice (GMP) guidelines require that Alert Limits be established by processing the data generated in the process, accompanied by regular monitoring of the system at chemical and microbiological levels. The parameters of the Water Treatment System were studied during the years 2021 and 2022, using basic Quality and Statistical Process Control tools. Data was extracted from the daily control carried out directly on the system, from monthly chemical and microbiological analyses, and also from daily water analyses performed on each production line. Trend Analysis made it possible to assess the natural behavior of the process and its trends, as well as the associated causes of variation. During the study period, a change was made to the Water Treatment System, which affected several parameters, namely Chlorine and pH, and also a reduction in the dispersion of the results. Twenty Alert Limits applied to the system were revised for parameters whose specification limits were out of line and prevented a rigorous analysis of the process, such as TOC and Conductivity. Seven Action Limits were also defined for direct daily control parameters where the previously limits did not fit in with the process trend. The new Alert Limits established are narrower, allowing rigorous monitoring of the system, with greater capacity for responder and action, as required by recent GMP guide- lines.
The main objective of this study is to establish new Alert Limits for the parameters ana- lyzed in the Water Treatment System for Pharmaceutical Purposes. Recent Good Manufactur- ing Practice (GMP) guidelines require that Alert Limits be established by processing the data generated in the process, accompanied by regular monitoring of the system at chemical and microbiological levels. The parameters of the Water Treatment System were studied during the years 2021 and 2022, using basic Quality and Statistical Process Control tools. Data was extracted from the daily control carried out directly on the system, from monthly chemical and microbiological analyses, and also from daily water analyses performed on each production line. Trend Analysis made it possible to assess the natural behavior of the process and its trends, as well as the associated causes of variation. During the study period, a change was made to the Water Treatment System, which affected several parameters, namely Chlorine and pH, and also a reduction in the dispersion of the results. Twenty Alert Limits applied to the system were revised for parameters whose specification limits were out of line and prevented a rigorous analysis of the process, such as TOC and Conductivity. Seven Action Limits were also defined for direct daily control parameters where the previously limits did not fit in with the process trend. The new Alert Limits established are narrower, allowing rigorous monitoring of the system, with greater capacity for responder and action, as required by recent GMP guide- lines.
Descrição
Palavras-chave
Limites de Alerta Tratamento de Água Tendências