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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 ...
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 ...
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 ...
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 ...
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 ...
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 ...