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