Quality Featured Articles
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Pharma QMS: Simplify Your Quality Management Practices
8/27/2025
Manufacturers are embracing advanced technologies to enhance Quality Management Systems and ensure faster defect detection and compliance with FDA standards. Learn more about key pharma QMS features.
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Overcoming Challenges In Ophthalmic Formulations Through Polymer Selection
8/27/2025
The growing demand for ophthalmic drugs is driven by aging populations and increased screen time, which contributes to rising eye conditions. Explore innovative solutions in ophthalmic drug development.
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New FDA White Paper Ties Quality To Financial Benefits
8/26/2025
The agency presents as a stepwise approach in which companies can make incremental investments rather than committing large amounts of capital upfront.
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How AI Is Revolutionizing Quality Management Systems
8/13/2025
The real question isn't whether pharmaceutical companies should adopt AI in their quality systems, but how to implement it effectively and what specific benefits to expect.
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Biotech's Plastic Problem Meets Its Match
8/8/2025
Explore how a partnership with UW–Madison and Genentech developed a breakthrough recycling technology that is poised to reshape single-use bioprocessing sustainability.
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What Happens When You Refuse To Compromise On Sustainability?
8/8/2025
Discover how an empty building shell became a sustainable nanomedicine hub and achieved 47% energy savings and 88% fewer emissions, which sets new standards for innovation in the biologics industry.
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Redefining Process Design And The Evolution Of Critical Process Parameters
8/6/2025
Effectively managing process parameters and quality attributes is vital for successful drug development. Learn how a Quality by Design approach can optimize your processes and ensure product quality.
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EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance
8/6/2025
The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.
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Minimizing The Impact Of Human Errors Using Relational Risk Analysis
8/4/2025
This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.
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Why Is It Important To Have Properly Trained Visual Inspectors?
8/4/2025
Properly trained visual inspectors are crucial for identifying defects in parenteral drugs, safeguarding patient safety and product quality.