Featured Pharma Online Editorial
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ICH Revises Q1 Guideline, Advancing Stability Testing Standards
4/24/2025
In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.
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Why Pharma Risk Assessments Should Include 'Working Together Alone'
4/16/2025
When understood and managed properly, subjectivity becomes a source of creativity. It reveals hidden hazards and unlocks more effective risk controls.
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How AI Is A Game-Changer For Auditing Compliance And Efficiency
4/9/2025
In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.
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Amgen's Deep Learning Approach To Vial Inspection
3/31/2025
The company is testing how artificial intelligence can help bring down the number of false rejections caused by factors like glare on the glass or bubbles in the vial.
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Upskilling Your Quality Team For The AI Revolution In Pharma 4.0
3/21/2025
While AI systems offer advanced capabilities for data analysis, process optimization, and quality assessments, your quality team must first be proficient in interacting with them.
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What FDA Draft Guidance Tells Us About In-Process Control Strategies
2/28/2025
The draft aims to modernize the regulations in 21 CFR 211.110 catching up to progress in the field including advanced manufacturing and analytical technologies.
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Areas For Advancement In Peptide Manufacturing
2/27/2025
Experts from Eli Lilly, NervGen, and Piramal Pharma Solutions discuss the myriad of ways peptide manufacturing can be improved, drawing on years of industry experience and insight.
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9 Reasons Why You Should Consider AI In Analytical Instrument Qualification
2/21/2025
AI is about to completely change the analytical instrument qualification (AIQ) landscape in the pharma/biopharma and medical device industries.
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A Look At Pharmaceutical Inspection Machine Advanced Technologies
2/7/2025
Pharma and biotech companies are increasingly using inspection machines with advanced technologies, such as x-ray inspection, robotics, and more, to help them get ahead of the competition.
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2024 Trends In FDA Observations For Sterile Drug Manufacturers
1/30/2025
This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?