Featured Pharma Online Editorial
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Capturing Tablet Disintegration for Improved OSD Development
10/15/2026
Closed-loop laboratory automation promises to make oral solid dosage form development faster and more efficient, but the behavior of powders, tablets and dissolution processes remains difficult to predict.
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Why We Need Pharmaceutical Engineering Project Management As A Distinct Discipline
10/13/2026
Applying general project management to a regulated setting as a variant of PMP or PRINCE2 is one of the most consistent, and most avoidable, causes of cost overrun and delayed start-up.
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DEA Reveals Hidden Costs Of Analytical Validation Guidelines
10/2/2026
By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.
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Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
10/2/2026
Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.
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Why CMC Tech Transfer Should Begin With The End In Mind
10/1/2026
This interview with Sai Life Sciences’ Tuneer Ghosh explains why CMC technology transfer should begin with commercialization and lifecycle goals in mind. It highlights how early planning for scale, CDMO involvement, supply resilience, regulatory requirements, process safety, and shared learning can support a smoother, more sustainable transfer.
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ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions
9/28/2026
A former FDA assessor explains how recent changes to the common technical document bring long-overdue updates to the submission process, accounting for greater data demands.
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4 Ways To Build A Better CMC Tech Transfer
9/23/2026
A technology transfer can falter long before a process reaches the plant. Gaps in process knowledge, mismatched equipment, and insufficient scale-up data can all undermine reproducibility, timelines, and cost.
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Building Trust In AI For Computerized System Validation
9/4/2026
Using AI for CSV might feel like the students are grading their own papers. One consultant explains why it's not the same, namely, there are no subjective judgment calls.
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When To Trust And When To Verify AI-Enabled Validation Systems
9/3/2026
Computer software assurance, coupled with AI, can help validation teams reduce redundant work and spend more time on patient-centric issues.
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AI Governance Is Just Like Driving A Race Car
9/1/2026
Though some skeptics remain, nearly every business is at some stage of AI adoption. The technology has proven applications in pharmaceutical manufacturing, but effective governance must keep pace with its rapid development. That challenge is familiar to Bill Reid, healthcare and life sciences lead in Google’s Chief Information Security Office (CISO).