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Revista Cubana de Farmacia

versão On-line ISSN 1561-2988

Resumo

ONA ALDAMA, Nancy; HERNANDEZ ORAMAS, Idania; PORTUONDO CAMPBELL, Beatriz  e  DIAZ DE ARMAS, Miriam. Sistema de inspección de la planta de reactivos clínicos. Rev Cubana Farm [online]. 2000, vol.34, n.2, pp. 113-119. ISSN 1561-2988.

One of the main premises of quality control is to detect the deficiencies in the manufacture of products during the productive process and to analyze the causes of inconformities and erradicate them. Each stage of the manufacturing process should be controlled, so an Inspection System is necessary that allows to increase the probability that the finished product meets all the quality and design specifications. The objective of the present paper was to detect the main problems affecting the quality of reagents made at the Plant of Clinical Reagents, to design and implement its Inspection System, describing the control points, the way to carry out the inspections at the different points and the frequency and the aspects to be controlled, as well as to analyze the results obtained once the system has been established. A Program for Continual Improvement was also put into practice in order to make the implanted system better. Techniques such as the expert method, the Pareto diagram, the Pause-effect method, among others, were used to determine the fundamental problems and their causes. With the design and implementation of the system it was possible to reduce significantly the defects of the finished product and to improve the application of the system.

Palavras-chave : CONTROL DE CALIDAD; INDICADORES Y REACTIVOS; INDUSTRIA FARMACEUTICA..

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