Listar por tema "Pharmaceutical industry--Quality control"
Mostrando ítems 1-20 de 55
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Application of DMAIC Methodology to Improve the Utilization of an Industrial Glassware Washer System in a Biopharmaceutical Industry
(Polytechnic University of Puerto Rico, 2009)Abstract ⎯ This article describe how the problem solving approach of Define, Measure, Analyze, Implement and Control (DMAIC) is applied to increase the utilization of an industrial glassware washer system in a Biopharmaceutical ... -
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 ... -
Computer System Validation CSV in Data Integrity Implementation Strategies for Pharmaceutical Industry
(Polytechnic University of Puerto Rico, 2018)Computer System Validation CSV in Data Integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original ... -
Cycle Time Reduction using Lean Manufacturing Techniques for a Solid Pharmaceutical Product
(Polytechnic University of Puerto Rico, 2009)Abstract ⎯ The purpose of this project was to demonstrate that the Lean Manufacturing techniques could be applied to a Solid Pharmaceutical Product in order to reduce the cycle time. During the year 2007, the Solid ... -
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 ... -
Design Project for Process Improvement of the Manufacturing of Electrode Ring –Monolithic Controlled Released Devices (MCRDs)
(Polytechnic University of Puerto Rico, 2021)Medtronic Rice Creek Pharmaceutical Operations at Fridley, Minnesota currently build the Electrode Ring, Monolithic Controlled Released Device (MCRD) assembly which is sent to Medtronic Villalba ... -
Determination of In-Processing Manufacturing Impact into Elution Rate of Drug Eluting Steroid Collars
(Polytechnic University of Puerto Rico, 2012)Abstract - The Food and Drug Administration provides regulations for combination products. The medical device industry needs to comply with these regulations specifically in products containing drug. One of the many ... -
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 ... -
Development of Bulk Shipping Studies in Pharmaceutical Industry
(Polytechnic University of Puerto Rico, 2012)Abstract ⎯ A bulk shipping study in the pharmaceutical industry consists in monitoring and analyzing the environmental conditions (e.g. temperature and relative humidity) during shipping and transportation of the drug ... -
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 ... -
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 ... -
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 ... -
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 ...