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Enhancement of Batch Review Report for Annual Product Reviews in the Pharmaceutical Industry
(Polytechnic University of Puerto Rico, 2015)
The pharmaceutical industry is required
to comply with various regulatory agencies which
determine the industry capabilities for compliance
and allow the marketing of their products.
Regardless the regulatory agency ...
Shipping and Transportation Studies to Evaluate Drug Product Quality
(Polytechnic University of Puerto Rico, 2015)
Many pharmaceutical or
biotechnological products require transport using
temperature-controlled systems to maintain their
therapeutic properties. There are presently no
official guidelines for testing pharmaceutical
products ...
DMAIC Application to Reduce Medication Errors in a Specialized Pharmacy Process
(Polytechnic University of Puerto Rico, 2014)
Medication errors can have serious
consequences for patients, and medication safety is
essential to pharmaceutical care. Insight is needed
into the vulnerability of the working process at
specialized pharmacies in order ...
Raw Material Sampling Process Optimization using Lean Six Sigma Methodology
(Polytechnic University of Puerto Rico, 2014)
Pharmaceutical Industry needs reduce
the costs without impact the quality of the product.
The principal objective of this project is the
reduction of the cycle time of a raw material
sampling process from 8 days to 2 ...
Development of General Guidelines for the Pharmaceutical Manufacture Company Reaction to a Consent Decree Emitted by the Federal Drug Administration (FDA)
(Polytechnic University of Puerto Rico, 2009)
Abstract ⎯ Consent Decrees have been very popular lately. The consent decree mandates that a company start initiating change, and that change is usually associated with the way the company is manufacturing a product; and, ...
Optimization of Chemical Manufacturing Process Area
(Polytechnic University of Puerto Rico, 2014)
“Industry X” does not have a detailed
and effective plan for chemical weighing process
which considers optimal number of operators and
shifts necessary to accomplish the desired
production. The products process flow ...
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 ...
Coating Process Improvements in Solid Dose Form Manufacturing
(Polytechnic University of Puerto Rico, 2013)
Organization’s goals and objectives
use strategic scorecards that include Quality,
Economics, Speed and Culture to establish business
metrics focused on building continuous future
success and competitiveness to create ...
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 ...
Optimization of On-Line Automated Dissolution System for Solid Dose Control Release Tablets
(Polytechnic University of Puerto Rico, 2009)
Abstract ⎯ An optimization of an automated dissolution system for control release tablets has been accomplished by the implementation of several variables using Six Sigma tools. Variables under evaluation includes: filter ...