Examinando por Autor "Castro Torres, Carlos Alberto"

Seleccione resultados tecleando las primeras letras
Mostrando 1 - 1 de 1
  • Miniatura
    PublicaciónAcceso abierto
    Implementación del sistema de calidad por diseño para procesos de manufactura de formas farmacéuticas sólidas en laboratorios peruanos
    (Universidad Privada Norbert Wiener, 2018-04-10) Castro Torres, Carlos Alberto; Jáuregui Maldonado, José Fidel
    The importance of Quality by Design (QbD) implies supplementing activities and tools with a scientific approach that allows for the adequate manufacture of pharmaceutical products with a high degree of safety and harmlessness. The contribution of the QbD system for solid pharmaceutical dosage form manufacturing processes allows for the application of a new way to improve manufacturing processes, starting from new specialized concepts linked to the product life cycle. These concepts are outlined in articles, journals, regulations, and international guidelines such as those from the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the International Council for Harmonisation (ICH). These new specialized concepts provide Peruvian pharmaceutical laboratories with greater process knowledge to identify critical points through risk analysis and to control them from the product development stage, through industrial manufacture, and continuous process verification, maintaining traceability that ultimately allows for greater control, always focused on continuous improvement to ensure quality throughout the product life cycle. The purpose of this research was to implement process validation in Peruvian laboratories, migrating from the traditional manufacturing process to the Quality by Design system approach. This approach covers product design, process design, process transfer, process performance before and during industrial manufacture, and continuous process verification. Furthermore, it aimed to identify critical quality attributes and process parameters that may have a critical impact on the product. These were identified through risk analysis to be controlled by establishing design spaces, thereby ensuring compliance with acceptance criteria, which allows for a safer pharmaceutical product for the patient.