Drugs

ICH Signals New Standards for Advanced Drug Manufacturing

The International Council for Harmonization (ICH) has outlined a roadmap for future global standards on advanced drug manufacturing, highlighting gaps in current regulatory frameworks and calling for new guidelines to support emerging technologies. In a reflection paper recently endorsed by the ICH Assembly, regulators and industry stakeholders identified process modeling, continuous process verification, and decentralized manufacturing as priority areas for future harmonization.

The paper builds on the relatively recent adoption of ICH Q13 guideline, which was designed to support the uptake of continuous manufacturing across regions. While Q13 established foundational principles, ICH says significant innovation has moved beyond its scope, creating the need for additional regulatory clarity.

“Advanced manufacturing technologies offer clear benefits, but consistent technical standards and risk frameworks remain limited,” the group notes, emphasizing that greater alignment between regulators and manufacturers is critical to ensure product quality and accelerate adoption.

A major focus of the paper is the growing role of process models, including those powered by artificial intelligence, in pharmaceutical manufacturing. These models can simulate and control production processes in real time, improving efficiency and quality. However, ICH flags the absence of harmonized global standards for:

Model validation and lifecycle management
Risk classification frameworks
Regulatory expectations for updates and changes

The rise of AI-driven models adds further complexity, with regulators still developing approaches to oversee systems that continuously learn and evolve, the paper says.

The paper also highlights continuous process verification as a promising but underutilized alternative to traditional batch-based validation. Unlike conventional methods that rely on a fixed number of pre-approval batches, continuous verification uses real-time data from ongoing production. According to ICH, broader adoption could improve process understanding, enable earlier detection of variability and risk, and support continuous improvement across a product’s lifecycle. Still, uncertainty around regulatory expectations has slowed uptake, prompting calls for clearer global guidance.

Another emerging area is decentralized or distributed manufacturing, where drug production is spread across multiple smaller sites rather than centralized facilities. This model could increase flexibility and resilience in supply chains, particularly when paired with advanced monitoring and data-sharing systems. But the approach raises new regulatory questions, ICH says, including:

How to manage quality systems across multiple locations
How to ensure product consistency and comparability
How to adapt testing and release requirements for smaller, distributed batches

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