Quality Featured Articles
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How To Leverage Microcurrent High Voltage Leak Detection Technologies
7/16/2018
Using HVLD in the the pharmaceutical industry - leveraging test method development on some products to validate other products.
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Innovative Robotic Handling For Pre-filled Syringes
7/12/2018
Addressing the challenge of implementing an inspection method to automate testing pre-filled syringes in a nested tray.
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Maintaining Data Integrity With Inspection Software
2/23/2018
It may sound like just another pharma and life sciences industry buzzword, but “Data Integrity” is as important as computer system validation when products get released to market.
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The Role Of Packaging In Supply Chain Management
2/14/2018
In order to achieve a successful supply chain management, packaging systems have to be connected with aspects of marketing, logistics, productions, and the environment.
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Navigating The Marketing Authorization Process In Europe
2/6/2018
To be able to market a medicinal product in Europe, you must obtain a Marketing Authorization (MA) from the relevant regulatory authority. There are a number of different routes to apply for an MA.
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Fast-Tracking A QbD Approach
12/28/2017
QbD starts with an understanding of the quality target product profile. This allows potential critical quality attributes (CQAs) to be established and a risk assessment performed.
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Regulatory Guidance and Engineering For Sterile Drug Manufacturing Facilities
9/21/2017
This article provides an overview of the regulatory guidelines and the fundamental GMP requirements with regards sterile manufacturing of medicinal products, with a particular focus on engineering aspects.
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Container Closure Integrity Testing Utilizing Mass Extraction Technology
9/7/2017
Mass extraction tests are nondestructive and offer higher measurement sensitivity. In addition, the instruments are efficient, offer short test times, and are more accurate than many of the other methods.
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Understanding And Delivering Your EU Orphan Drug Launch
8/25/2017
Although the European marketplace presents a significant opportunity for innovative orphan drug companies to meet unmet patient needs, launching your drug product can present a real challenge.
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A Paradigm Shift In Container Closure Integrity Of Parenteral Drugs
7/25/2017
This latest evolution of HVLD aims to achieve a high level of closed container integrity (CCI) assurance across the entire range of parenteral products.