| Revista: | Brazilian Journal of Pharmaceutical Sciences |
| Base de datos: | PERIÓDICA |
| Número de sistema: | 000451910 |
| ISSN: | 1984-8250 |
| Autores: | Costa, Mayre Aparecida Borges da1 Brandão, Amanda Lemette Teixeira2 Pinto, José Carlos3 Nele, Márcio3 |
| Instituciones: | 1Universidade Federal do Rio de Janeiro, Faculdade de Farmacia, Rio de Janeiro. Brasil 2Pontificia Universidade Catolica do Rio de Janeiro, Departamento de Engenharia Quimica e de Materiais, Rio de Janeiro. Brasil 3Universidade Federal do Rio de Janeiro, Escola de Química, Rio de Janeiro. Brasil |
| Año: | 2022 |
| Volumen: | 58 |
| País: | Brasil |
| Idioma: | Inglés |
| Tipo de documento: | Artículo |
| Enfoque: | Aplicado, descriptivo |
| Resumen en inglés | 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 |
| Disciplinas: | Química |
| Palabras clave: | Química farmacéutica, Purificación de agua, Metodología, Industria farmacéutica, Agua purificada, Control de calidad |
| Keyword: | Medicinal chemistry, Water purification, Methodology, Quality control, Pharmaceutical industry, Purified water |
| Texto completo: | Texto completo (Ver HTML) Texto completo (Ver PDF) |
