Pharmaceutical manufacturing’s digital transformation is constrained not by a lack of data, but by decision velocity: the speed, quality, and auditability of translating operational signals into compliant actions.

Quality professionals in all industries are heavily involved in root-cause analysis (RCA) and corrective and preventive action (CAPA) management. As artificial intelligence (AI) systems emerge to augment these quality functions, the industry faces a fundamental challenge: no comprehensive regulatory framework exists to govern AI application in GxP environments.

Spray drying has become a key enabling technology for developing amorphous solid dispersions (ASDs) to enhance solubility and bioavailability in poorly water-soluble drug candidates.

By adopting artificial intelligence (AI) and machine learning (ML), the life sciences industry can leverage dynamic systems, a completely new system design. These systems feature ML models that learn adaptively automatically from data, accommodating changing relationships between input and output over time.

The transition from on-premise to cloud-based systems requires a shift in how IT infrastructure is managed in regulated environments. Rather than traditional static qualification, continuous operational control of Platform as a Service (PaaS) infrastructure supporting GxP applications enables life sciences companies to maintain compliance and accelerate innovation.

Artificial intelligence (AI) is transforming how GxP-regulated areas of life sciences operate. As AI grows ever more capable, people are rethinking humans’ role in an increasingly technology- and data-driven world. With key competencies of AI literacy and data understanding being of paramount importance, strong critical thinking skills become ever more essential for effective oversight.

This article proposes a practical model for validation in a digital landscape. It incorporates emerging thinking on culture, risk competencies, and modern software assurance approaches for validating computerized systems.

The pharmaceutical industry has always evolved through the thoughtful application of science and technology. Digital intelligence represents the next chapter in that journey.

In a high-pressure, always-on world, resilience has become one of the most sought-after capabilities in both professional and personal life. Yet it is still widely misunderstood. Too often, resilience is treated as a fixed trait—something you have or you don’t. The reality is far more nuanced.

The pharmaceutical and biopharmaceutical industry has never demanded more of the next generation than it does today. Accelerating technologies, evolving regulatory landscapes, and unrelenting pressure to bring safe, effective therapies to patients faster will fall on the shoulders of the workforce of the future. ISPE understands this and has built a robust, multi-tiered pathway for those who...

New and tenured leaders often struggle with leadership imposter syndrome. It is characterized by feelings of self-doubt and uncertainty, and a lack of confidence, regardless of past successes and accomplishments. So, what can someone do to overcome these feelings and lead fearlessly?

ISPE’s 2026 AI in Life Sciences Summit—Powered by GAMP^® brought together a diverse group of regulators and pharmaceutical and technology professionals to address the growing opportunities and challenges for applying artificial intelligence (AI) in the pharmaceutical industry and to explore the rapidly evolving role of AI in regulated environments.

The new ISPE Guide: Quality Risk Management provides practical direction on applying QRM principles across the full product life cycle.

In each issue of Pharmaceutical Engineering^®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Logan Thomas, Website Manager, Conferences & Digital Engagements Team.