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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 ...
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 ...
Clean Steam Energy Conservation Process Design
(Polytechnic University of Puerto Rico, 2011)
Abstract ― The objective of this article is to design the sterilization methodology and processes needed in a product or equipment that requires the injection of clean steam to create a sterile environment. Clean steam is ...
Data Integrity Implementation Strategy for Pharma Industry
(Polytechnic University of Puerto Rico, 2017)
Data integrity is fundamental in a
pharmaceutical quality system which ensures that
medicines are of the required quality as decisions
on product quality are made based on the data.
Electronic data and computerized ...
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 the Registration Process of Products on the Pharmaceutical Industry of Puerto Rico
(Polytechnic University of Puerto Rico, 2018)
Registration Process for
pharmaceutical products in Puerto Rico has unique
requirements for the marketing, sale, and
distribution of the products. The Organizations
must be approved before they can market, sell ...
Implementación de Estrategias para lograr Cero- Errores o Defectos En las Operaciones durante Proceso de Granulación
(Polytechnic University of Puerto Rico, 2012)
Sipnósis- Un producto realizado con errores en documentación, pone en riesgo la efectividad, autenticidad y la integridad del mismo. Es por esto que debemos evitar cualquier desviación en el proceso, realizando una ...
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 ...
Reduction of Time in a Manufacturing Process for a Pharmaceutical Company Located in Puerto Rico
(Polytechnic University of Puerto Rico, 2012)
Abstract - The project is developed in a chemical plant of a pharmaceutical company in Puerto Rico. In 2011 the company had an increase in market demand of the active ingredient of one product. To ensure the profit plan, ...