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Cycle Time Reduction using Lean Manufacturing Techniques for a Solid Pharmaceutical Product
(Polytechnic University of Puerto Rico, 2009)
Abstract ⎯ The purpose of this project was to demonstrate that the Lean Manufacturing techniques could be applied to a Solid Pharmaceutical Product in order to reduce the cycle time. During the year 2007, the Solid ...
Estudio de los Aspectos Ergonómicos en Laboratorios de Control de Calidad en Industrias Farmacéuticas
(Polytechnic University of Puerto Rico, 2009)
Abstracto - El objetivo de esta investigación es conocer, cuan efectivo son los diseños ergonómicos en laboratorios de control de calidad de las industrias farmacéuticas. En esta investigación se realizó una evaluación de ...
Application of DMAIC Methodology to Improve the Utilization of an Industrial Glassware Washer System in a Biopharmaceutical Industry
(Polytechnic University of Puerto Rico, 2009)
Abstract ⎯ This article describe how the problem solving approach of Define, Measure, Analyze, Implement and Control (DMAIC) is applied to increase the utilization of an industrial glassware washer system in a Biopharmaceutical ...
Quality Risk Management Strategies for Computer Systems Validation
(Polytechnic University of Puerto Rico, 2014)
Quality Risk Management is something
that has been gaining attention in the regulated
industry because it is listed as regulation in various
regulatory agencies such as FDA, ICH, ISO, ISPE
and other involved regulatory ...
Are cleaning faults, really, quality or administrative issues?: Cleaning Validation Program optimization for a Pharmaceutical plant
(Polytechnic University of Puerto Rico, 2008)
The cleaning procedure process validation has generated considerable discussion when executing a US Food and Drug Administration (FDA) inspection at Pharmaceutical Plants. In general, the FDA requires the equipment to be ...