Validación de un Sistema Integrado de Gestión del área de control de calidad de un laboratorio para formas farmacéuticas sólidas.
xvi ABSTRACT The aim of this study is to validate an integrated management system applied to quality control area of a solid dosage forms pharmaceutical laboratory in order to achieve high quality, safety and environment standards. A comparative situation analysis using checklists, observation...
| Autor Principal: | Basantes Espín, Doris Tatiana |
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| Otros Autores: | Sánchez Quilo, William Renan |
| Formato: | masterThesis |
| Idioma: | spa |
| Publicado: |
2015
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| Materias: | |
| Acceso en línea: |
http://dspace.ups.edu.ec/handle/123456789/7792 |
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xvi
ABSTRACT
The aim of this study is to validate an integrated management system applied to quality
control area of a solid dosage forms pharmaceutical laboratory in order to achieve high
quality, safety and environment standards.
A comparative situation analysis using checklists, observation techniques, interviews,
measurements and techniques audit was carried out between the implementation of an
integrated system based on the 32 report of World Health Organization, SART System and
ISO 14001.
The results of the comparative analysis between the initial and final assessment were stated
in 38.10% performance improvement in three standard above cited, 19.05% improvement
in critical non-conformances, 4.76% improvement in major nonconformities and 14.29%
improvement in minor non-conformances, then the integrated system is validated.
This concludes that the implementation of an integrated system is valid and applicable to
the pharmaceutical laboratory, then could be taken as a study case and extrapolated to
other companies with similar activities. |
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