Browsing Manufacturing Competitiveness by Subject "Pharmaceutical industry--Quality control"
Now showing items 1-20 of 24
-
Are cleaning faults, really, quality or administrative issues?: Cleaning Validation Program optimization for a Pharmaceutical plant
(Polytechnic University of Puerto Rico, 2008)The cleaning procedure process validation has generated considerable discussion when executing a US Food and Drug Administration (FDA) inspection at Pharmaceutical Plants. In general, the FDA requires the equipment to be ... -
Audit Process Optimization in the Manufacturing Area
(Polytechnic University of Puerto Rico, 2021)This project was developed to demonstrate a viable audit process optimization in the manufacturing area. The AbbVie site ubicated in Barceloneta, Puerto Rico,started with only one product back in ... -
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 ... -
Cleaning Validation of a Manufacturing Line using CIP-100 Detergent and a Clean-in-place Skid System
(Polytechnic University of Puerto Rico, 2022)Cleaning Validation is a prime element of control to the cross contamination and potential carry over topic at the manufacturing industry. This process must assure the quality, safety and efficiency of cleaning ... -
Coating Process Improvement
(Polytechnic University of Puerto Rico, 2021)An increase in the number of events associated to AQLfailure that resulted on partial batch rejections was observed in 2020 for Tablets/Caplets formulations due to cosmetic conditions ... -
Coating Process Improvements in Solid Dose Form Manufacturing
(Polytechnic University of Puerto Rico, 2013)Organization’s goals and objectives use strategic scorecards that include Quality, Economics, Speed and Culture to establish business metrics focused on building continuous future success and competitiveness to create ... -
Development of General Guidelines for the Pharmaceutical Manufacture Company Reaction to a Consent Decree Emitted by the Federal Drug Administration (FDA)
(Polytechnic University of Puerto Rico, 2009)Abstract ⎯ Consent Decrees have been very popular lately. The consent decree mandates that a company start initiating change, and that change is usually associated with the way the company is manufacturing a product; and, ... -
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 ... -
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 ... -
Estudio de los Aspectos Ergonómicos en Laboratorios de Control de Calidad en Industrias Farmacéuticas
(Polytechnic University of Puerto Rico, 2009)Abstracto - El objetivo de esta investigación es conocer, cuan efectivo son los diseños ergonómicos en laboratorios de control de calidad de las industrias farmacéuticas. En esta investigación se realizó una evaluación de ... -
Evaluation to Sleeves Used in Granulation Department for the Graduate Programs at Polytechnic University of Puerto Rico
(Polytechnic University of Puerto Rico, 2021)The DMAIC methodology was applied to analyze a manufacturing system at Johnson & Johnson Pharmaceuticalsin Las Piedras, Puerto Rico. The methodology was used to improve the time for changing and ... -
Execution of Lean Techniques for Cost improvement in a Quality Area of a Small Regulated Company established in Puerto Rico
(Polytechnic University of Puerto Rico, 2022)A small regulated company established in Puerto Rico developed a cost improvement project on a Quality Area to stay competitive. The main objective was to reduce the number of samples sampled ... -
Handling and Managing of Vial Rejects
(Polytechnic University of Puerto Rico, 2021)A large accumulation of filled vial rejects generated in an aseptic filling line of a parenteral medication was identified to be in the custody of the Quality Assurance department indefinitely. Using the DMAIC methodology ... -
Inventario y 5s en un Laboratorio de Control de Calidad
(Polytechnic University of Puerto Rico, 2022)Un laboratorio de control de calidad de una farmacéutica es el encargado de asegurar la calidad del producto que allí es manufacturado. Por medio de esta investigación se busca implementar la metodología de 5S y de ... -
Optimización del Proceso de Revisión de los Registros de Manufactura
(Polytechnic University of Puerto Rico, 2018)La consistencia en la ejecución de las tareas en la industria farmacéutica es uno de los factores más importantes para obtener un producto de calidad. Se utilizó el concepto Lean y la metodología DMAIC para optimizar el ... -
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 ... -
Optimization of On-Line Automated Dissolution System for Solid Dose Control Release Tablets
(Polytechnic University of Puerto Rico, 2009)Abstract ⎯ An optimization of an automated dissolution system for control release tablets has been accomplished by the implementation of several variables using Six Sigma tools. Variables under evaluation includes: filter ... -
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 ... -
Process Time Reduction in Manufacturing Areas: Visual Valves Identification on Manufacturing Area specifically on Media Prep Area, Media Preparation tanks to Pursue Agility on the Visual inspections required before, during and after the Media Prep Solution are Prepared
(Polytechnic University of Puerto Rico, 2022)Time of production process and associate activities were evaluated for Media Prep manufacturing process on Juncos, P.R. The voice of the customer requested reduced time inspection process before, ... -
Process Validation: Batch Size Increase in the Downstream Process
(Polytechnic University of Puerto Rico, 2023)The worldwide demand for the drug substance has increased by 30%. The drug substance is an ingredient used in the final product formulation, which later becomes the medicine that will reach the patients. The challenge that ...