Quality Risk Management (QRM) in the pharmaceutical industry and especially in the manufacture of sterile products is of vital importance for its impact on health. The objective of this work is, to design and jointly apply risk management matrices to validate the aseptic process of injectable solutions. For the design of the Simulated Aseptic Process (APS) the following risk matrices were developed: Risk matrix for the determination of the worst case; Time matrix of the simulated aseptic process; Risk Matrix of Failure Mode and Effect Analysis (FMEA); Risk matrix routine and non-routine interventions. It is concluded that the joint and complementary use (not exclusive) of the risk analysis tools of this work and their respective matrices is a guide that helps methodologically to discern the risk and contribute to properly manage the APS. Likewise, the incorporation of the matrices of sys...

La Gestión de Riesgos de la Calidad (QRM) en la industria farmacéutica y especialmente en la fabricación de productos estériles es de vital importancia por su impacto en la salud. El objetivo del presente trabajo es, diseñar y aplicar en forma conjunta matrices de gestión de riesgo para validar el envasado aséptico de soluciones inyectables. Para el diseño del Envasado Aséptico Simulado (APS) se elaboraron las matrices de riesgo siguientes: Matriz de riesgo para la determinación del peor caso; Matriz de tiempos del proceso aséptico simulado; Matriz de Riesgo de Análisis del Modo y Efecto de Fallas (FMEA); Matriz de riesgo intervenciones rutinarias y no rutinarias. Se concluye que la utilización conjunta y complementaria (no excluyente) de las herramientas de análisis de riesgo del presente trabajo y sus respectivas matrices constituye una guía que ayuda metodológicamente ...

Objective: To establish which are the processes that generate value for the patient / user in the Pharmaceutical Office. Material and methods: the literature review and critical reading of the theory of value generation for the patient / user was carried out; as well as the application of these concepts to the generation of professional value of the Pharmaceutical Chemist and the identification of the processes that generate value in the Pharmacy Office. Results: The processes that generate value at the level of activities that the Chemist Pharmacist as Technical Director performs or supervises were identified, and he is responsible in the pharmacy office. These activities have been grouped into: Activities oriented to the Product, the Patient and the Community and, that each one of them is related to the fulfillment of the Good Practices of Storage, Dispensation, Pharmacotherapeutic Fol...

Objective: To establish which are the processes that generate value for the patient / user in the Pharmaceutical Office. Material and methods: the literature review and critical reading of the theory of value generation for the patient / user was carried out; as well as the application of these concepts to the generation of professional value of the Pharmaceutical Chemist and the identification of the processes that generate value in the Pharmacy Office. Results: The processes that generate value at the level of activities that the Chemist Pharmacist as Technical Director performs or supervises were identified, and he is responsible in the pharmacy office. These activities have been grouped into: Activities oriented to the Product, the Patient and the Community and, that each one of them is related to the fulfillment of the Good Practices of Storage, Dispensation, Pharmacotherapeutic Fol...