News Brief: FDA Releases Draft Guidance on 21 CFR 211.110 Compliance
On January 2, the U.S. Food and Drug Administration (FDA) published a draft guidance document titled Considerations for Complying With 21 CFR 211.110, which was aimed at pharmaceutical manufacturers. The document focuses on ensuring batch uniformity and drug product integrity while promoting the adoption of advanced manufacturing technologies.
The document outlines a scientific and risk-based framework for monitoring in-process materials and employing innovative manufacturing methods such as continuous manufacturing and 3D printing. These advancements, combined with real time monitoring systems like process analytical technology, assist in quality and efficiency in production, according to the document. In addition, the document highlights the following:
Advanced manufacturing: The FDA supports transitioning to advanced manufacturing techniques, integrating innovative approaches for consistent and reliable drug production. This aims to bolster supply chains and expedite access to high-quality medicines.
Process model integration: The document details how process models “can be used to help monitor the attributes of in-process materials that affect the drug product’s critical quality attributes.” However, it also states “current process models cannot ensure the continued validity of all of the model’s underlying assumptions at all times, particularly during certain unplanned disturbances.”
Flexibility in compliance: The document encourages manufacturers to adopt creative solutions for process control while complying with current good manufacturing practice standards.
Industry collaboration: The FDA encourages industry stakeholders to discuss alternative control strategies early in the drug development process. These conversations would help inform future regulatory policies and encourage the broader adoption of modern techniques.
Considerations for Complying With 21 CFR 211.110 is available here: URL. Comments must be submitted by April 7, 2025.