ESTUDIO DE LAS ETAPAS CRÍTICAS DEL PROCESO DE PRODUCCIÓN DE UN POLIFÁRMACO/TABLETAS DE DIPIRONA CON DIAZEPAM.

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Bibliographic Details
Title:	ESTUDIO DE LAS ETAPAS CRÍTICAS DEL PROCESO DE PRODUCCIÓN DE UN POLIFÁRMACO/TABLETAS DE DIPIRONA CON DIAZEPAM.
Authors:	Vigo, Marlén Vistel¹, Rubio, Arlobia Bosch¹, Diegues, Isabel Falcón¹
Source:	Tecnología Química. 1999, Vol. 19 Issue 2, p60-65. 6p.
Subjects:	Total quality control, Quality control, Drugs, Manufacturing processes, Pharmaceutical industry
Abstract (English):	The need to increase our production quality, including polymedicaments non collected in Pharmacopeias, in the light of the total quality control, which is a premise for the performance of the circular letter from the State Center for Drug Control (CECMED), in relation to the process validation and the demonstration of the good performance of existing drugs. This led to a deepening in critical stages from the production process of such formula: the dry powder blending and the compression. The feasibility of attaining a lower range for the average mass by means of an adequate adjustment of shaping machines and the influence of stages after the dry blending in obtaining the sample homogeneity. [ABSTRACT FROM AUTHOR]
Abstract (Spanish):	La necesidad de elevar la calidad de nuestras producciones, incluyendo los polifármacos no recogidos en Farmacopeas, a la luz del control total de la calidad, lo que constituye una premisa para el cumplimiento de la circular del Centro Estatal para el Control de los Medicamentos (CECMED) en relación con la validación de los procesos y la demostración del buen desempeño de los medicamentos existentes, conllevó una profundización en las etapas críticas del proceso de producción de dicha fórmula: el mezclado seco de los polvos y la compresión. Se demuestra la factibilidad de lograr un rango menor para la masa promedio mediante un adecuado ajuste de las máquinas troqueladoras y la influencia de las etapas posteriores al mezclado seco en la obtención de una adecuada homogeneidad de la muestra. [ABSTRACT FROM AUTHOR]
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Database:	Engineering Source

Description
Abstract:	The need to increase our production quality, including polymedicaments non collected in Pharmacopeias, in the light of the total quality control, which is a premise for the performance of the circular letter from the State Center for Drug Control (CECMED), in relation to the process validation and the demonstration of the good performance of existing drugs. This led to a deepening in critical stages from the production process of such formula: the dry powder blending and the compression. The feasibility of attaining a lower range for the average mass by means of an adequate adjustment of shaping machines and the influence of stages after the dry blending in obtaining the sample homogeneity. [ABSTRACT FROM AUTHOR]
ISSN:	00418420