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Alternate Raw Material Supplier Validation
(Polytechnic University of Puerto Rico, 2019)
This article discusses the Process Validation of Over the Counter Pharmaceutical Product using alternate supplier of raw material. The primary ibuprofen drug substance supplier for GSK Ibuprofen family products informed ...
Evaluation of Reagents Used in Solution Preparation to Reduce Reworks in Research and Development Laboratories
(Polytechnic University of Puerto Rico, 2019)
Research and development laboratories
are working with improvements and discovery of
new drugs. As part of their activities, they need
solutions such as Buffers and Mobile Phases for
analytical testing. It was found ...
Mejorar la Eficiencia en el Laboratorio Químico de una Farmacéutica a través de Aplicaciones de Metodología de Calidad
(Polytechnic University of Puerto Rico, 2019)
Los laboratorios son de suma
importancia, no solo en las escuelas y
universidades; también lo son para las
investigaciones y las farmacéuticas. Estos son los
encargados de asegurar la calidad de sus productos.
Los ...
Material Qualification Process Improvement to Reduce the Cycle Time
(Polytechnic University of Puerto Rico, 2019)
This project was focused in improving
the material qualification process, reducing the
cycle time. A Documentation Checklist and Tracking
Sheet System were created as part of the
improvements. The Documentation Checklist ...
Optimización en el Proceso de Configuración de Recetas en los Sistemas de Serialización
(Polytechnic University of Puerto Rico, 2019)
La serialización en la industria
farmacéutica de Estados Unidos es uno de los
nuevos procesos que lleva pocos años de
implementado. En el mes de noviembre del 2018
fue efectivo que para poder vender y/o distribuir
productos ...
Neuromodulator Device Scrap Reduction Using DMAIC Methodology
(Polytechnic University of Puerto Rico, 2019)
This research project was focused in the
Scrap reduction in a final electrical test area of a
medical device company. The scrap is defined as the
number of dollars per units resulting from the cost of
rejected units ...
Lean transformation strategic journey: from an ordinary manufacturing site towards a world class manufacturing site
(Polytechnic University of Puerto Rico, 2019)
The MDP Company is a global medical
device leader company in musculoskeletal
healthcare market. One of its primaries
manufacturing facilities is located in Puerto Rico
where orthopedic implants and reconstructive
products ...
Improving the custom-built applications computerized system validation lifecycle for a medical device company
(Polytechnic University of Puerto Rico, 2019)
This research project was focused in the
improvement of the Custom-Built Applications
Computerized System Validation Lifecycle for a
Medical Device Company. A Computerized System
Validation is the process of documenting ...
Improving the SOP of managing controlled CII substances in the laboratory from receiving to discarding
(Polytechnic University of Puerto Rico, 2019)
As a contract manufacturing operation,
the needs of our clients are our priorities. The
inclusion of controlled substance schedule II to our
list of products has been a challenge that we are
still trying to overcome. ...
Yield improvement for anesthesia product at filling & packaging line
(Polytechnic University of Puerto Rico, 2019)
In the manufacturing process of
anesthesia, the yield for Fluxane product,
manufactured at ANESTHER Healthcare, is
consistently performing lower than target (2.785
bottles/kg) from tank F-SV-001 in comparison to
tank ...