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Development of Effectiveness Program through the Use of Productivity Metrics
(Polytechnic University of Puerto Rico, 2014)
The Overall Plant Effectiveness
Program has the purpose to improve the production
capacity and optimize operations performance in
an Active Pharmaceutical Ingredient (API)
manufacturing plant. It requires a complete
analysis ...
Engineering Study for the Feeding Operation Process of a Continuous Manufacturing Line
(Polytechnic University of Puerto Rico, 2016)
The use of continuous operations in
solid-dosage manufacturing is growing rapidly and
bringing benefits within pharmaceutical industry.
One of the benefits that the continuous operation
provides is that the development ...
Development of a Generic Pharmaceutical Solid Dosage Form Using Quality by Design (QbD)
(Polytechnic University of Puerto Rico, 2014)
The Pharmaceutical Generic Sector
has been growing over the past years and it is
expected to surpass brand drugs in sale over next
years. The FDA now recommends Quality by
Design to develop Generic Drugs. The present
work ...
Serialization and the Future of Product Traceability
(Polytechnic University of Puerto Rico, 2016)
Since the beginning of pharmaceutical
products and drugs, counterfeiting has been a
worldwide issue. Packed with minimal punishment,
illegal internet sales and unsecured physical
packaging, it has grown into an estimate ...
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 ...
Manufacture and Evaluation of an Experimental 37.5 kg Scale Batch of 0.103% w/w Ethinyl Estradiol Triturate (Formulation Number WC3074-01I)
(Polytechnic University of Pueto Rico, 2016)
Actavis Fajardo, is a Pharmaceutical
company dedicated to the manufacturing and
packaging of oral contraceptive products. Ethinyl
Estradiol is an intermediate product used to
incorporate Ethinyl Estradiol active in ...
Strategy for the Implementation of Raman Technology in the Raw Material Incoming Area
(Polytechnic University of Puerto Rico, 2014)
State of the art new technology to
identify raw materials is available for the
manufacturing industries to improve and accelerate
the identification process. This document will
cover the Raman technology, theory ...
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 ...
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 ...