In January 2025, the U.S. FDA issued draft guidance to help the pharmaceutical industry comply with 21 CFR 211.110, which outlines Current Good Manufacturing Practice (CGMP) requirements focused on the sampling and testing of in-process materials and drug products.

To ensure batch uniformity and drug product integrity, CGMP regulations require that manufacturing processes are designed and controlled so that in-process materials consistently and reliably meet predetermined quality requirements.

Acknowledging the complexity of modern pharmaceutical processes, the FDA promotes a scientific and risk-based approach to process control and drug product quality, including the adoption of advanced manufacturing as a foundation for improving overall quality and availability of medicines.

Advanced manufacturing refers to innovative pharmaceutical manufacturing technologies or approaches that have the potential to improve the reliability and robustness of the manufacturing process and supply chain, while also increasing timely access to high-quality drug products.

Examples include:

–          real-time quality monitoring tools, such as process analytical technology (PAT) and process models which help monitor and control in-process materials,

–          continuous manufacturing,

–          3D printing.

Manufacturers are encouraged to implement innovative strategies that best suit their specific operations, based on their understanding of the product and process, while maintaining compliance with CGMP requirements.

To accelerate the adoption of advanced manufacturing, the guidance highlights the importance of early collaboration with FDA teams.

Stakeholders are encouraged to review the full guidance and engage with the FDA for further support in implementing these strategies.

Before finalizing the guidance, the FDA invites stakeholders to submit comments on the draft version online via https://www.regulations.gov/docket/FDA-2024-D-5374/document, until April 7, 2025.

Note:

* This guidance applies to the manufacture of human drug products, including biological products, and animal drug products, however, it does not apply to the manufacture of active pharmaceutical ingredients (APIs).

** FDA guidance documents do not establish legally enforceable responsibilities but instead describe the agency’s current thinking on a topic and should be viewed as recommendations only.