Featured Pharma Online Editorial
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Building AI Readiness Through Cross Collaboration
7/22/2026
AbbVie’s Operations Quality Assurance Innovation Accelerator offers a practical model for moving from AI enthusiasm to governed, people-centered execution.
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Bayer Adds A Spine To Modularity For Scale Without Disruption
7/16/2026
Modular facility concepts offer a different path, giving manufacturers the ability to expand capacity stepwise, standardize core infrastructure, and adapt production environments as product portfolios evolve
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7 Facilities Pilot PreCheck for Faster Approval
7/13/2026
A more streamlined path to operational new pharmaceutical facilities in the U.S. may be on the horizon. Nearly a year after the PreCheck Pilot Program was introduced by the U.S. Food and Drug Administration (FDA) in August 2025, the first seven participating facilities have been announced.
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Transforming Computer System Validation In The Life Sciences Industry
7/10/2026
Regulators acknowledge how traditional CSV methods fail to meet modern demands for speed and flexibility. The scene is changing in favor of smarter, leaner validation.
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Inside Chugai's Digital Infrastructure Strategy
6/29/2026
When a facility is fully automated and designed for manufacturing flexibility, it needs a digital infrastructure that pulls the systems together, reports data accurately and efficiently, and recognizes areas for continuous improvement.
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[VIDEO] GLP-1 Manufacturing's New Bottlenecks At Multi-Ton Scale
6/24/2026
“At multi-ton scale, the challenge becomes less about making the molecule and more about controlling the variability of the process in this interconnected system,” explained Villain.
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Does The FDA's Plausible Mechanism Pathway Revolutionize The Way All Risks Are Analyzed?
6/23/2026
The FDA's new guidance on plausible mechanisms represents the first regulatory guidance-driven example of where the primary information source of a risk analysis is shifted from data-based to mechanism-based evidence.
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A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis
6/5/2026
This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.
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Why FAT Should Confirm Alignment, Not Reveal Its Absence
6/1/2026
In many aseptic fill/finish projects, the factory acceptance test (FAT) has become the first true integration test of the entire project. That is a problem. Here's how to flip that mindset.
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Applying Contamination Control By Design: A Practical Guide For CDMOs
5/26/2026
This article addresses the three contamination control challenges that are specific to the CDMO environment, provides five practical steps any organization can act on now, and more.