Application of HACCP for development of quality risk management in a water purification system
Braz. J. Pharm. Sci. (Online)
; 58: e191051, 2022. tab, graf
Article
em En
| LILACS
| ID: biblio-1394051
Biblioteca responsável:
BR40.1
ABSTRACT
Abstract The present work reports the implementation of the Hazard Analysis Critical Control Point (HACCP) methodology to analyze the water purification system of a pharmaceutical site, in order to assure the system quality and prevent failures. As a matter of fact, the use of HACCP for development and implementation of Quality Risk Management (QRM) is not usual in pharmaceutical plants and it is applied here to improve the performance of the water purification system of a polymerization pilot plant used to manufacture pharmaceutical grade polymer microparticles. Critical Control Points (CCP) were determined with the aid of a decision tree and questions were made to characterize whether identified hazards constitute actual CCPs and should be monitored. When deviations were detected, corrective actions were performed and action plans were used for following-up and implementation of corrective actions. Finally, microbiological and physicochemical parameters were analyzed and the obtained results were regarded as appropriate. Therefore, it is shown that HACCP constitutes an effective tool for identification of hazards, establishment of corrective actions and monitoring of the critical control points that impact the process and the quality of the final pharmaceutical product most significantly.
Palavras-chave
Texto completo:
1
Base de dados:
LILACS
Assunto principal:
Gestão de Riscos
/
Purificação da Água
/
Análise de Perigos e Pontos Críticos de Controle
Tipo de estudo:
Etiology_studies
/
Risk_factors_studies
Idioma:
En
Revista:
Braz. J. Pharm. Sci. (Online)
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
Brasil