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Evolutionary vs. Revolutionary: a Snap Shot of the Current Tendencies in Pharmaceutical Industry and the Impact of Process Analytical Technology and Continuous Manufacturing Processes
(Polytechnic University of Puerto Rico, 2013)
Food and Drug Administration (FDA)
challenges the pharmaceutical industry to innovate
itself and introduce ever higher quality standards
through the use of technology. Development of
continuous manufacturing systems ...
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 ...
Quality System Management for Process Analytical Technology Applications
(Polytechnic University of Puerto Rico, 2013)
Commonly the pharmaceutical industry
uses a system known as the traditional or
conventional process for the manufacturing of their
products. Now, it has been shown that the use of
other systems not only benefits in ...
Modifications to the Purified Water Storage and Distribution System Polytechnic University of Puerto Rico
(Polytechnic University of Puerto Rico, 2013)
The Purified Water is identified to play
an integral role in manufacturing operations.
Careful considerations and good manufacturing
practices must take place in order to minimize
contamination and bacterial load. It ...
Quality Risk Management in the Pharmaceutical Air Compressed Equipment Qualification Process
(Polytechnic University of Puerto Rico, 2013)
In the pharmaceutical industry every
product and every process associated with risks.
To maintain product quality throughout the product
life cycle, too much time and resources are
allocated. Risk is described in recent ...
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 ...
Risk Prevention in Syringe Filling Line in a Pharmaceutical Manufacturing Plant
(Polytechnic University of Puerto Rico, 2013)
Risk prevention in syringe filling line
can be achieved through the implementation of
“Defense in Depth” concepts. Defense in Depth is
based on the integration of 3-layers of operational
controls which are Equipment, ...
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 ...