FDA: ICH Q13 Guideline and Artificial Intelligence in Drug Manufacturing

On 1 March 2023, the final ICH Guideline Q13 on continuous manufacturing (CM) of active pharmaceutical ingredients and drug products was published by the FDA. In addition to the guidance, the agency also issued a discussion paper on AI for stakeholders' comments. With these publications, the FDA aims to facilitate the adoption of advanced manufacturing technologies for the pharmaceutical industry.

The 48-page document Q13 Continuous Manufacturing of Drug Substances and Drug Products, adopted as an ICH guideline in November 2022, enables global harmonization of regulatory approaches and contributes to broader implementation of continuous manufacturing of existing and developing drugs and APIs. Building on the existing International Council for Harmonization (ICH) Quality Guidelines Q7 through Q12, this guidance clarifies the concepts of continuous manufacturing and describes scientific and regulatory considerations. More detailed information about the ICH Q13 guideline can be found in the news of 2 December 2022.

The 17-page Discussion Paper on Artificial Intelligence in Drug Manufacturing was published by FDA's Center for Drug Evaluation and Research (CDER) and advocates, among other things, for adopting these emerging technologies. It is neither a new guideline nor a draft but is intended to solicit early feedback from stakeholders to inform future policy development.

Trends in drug development highlight the need for more flexibility in manufacturing. The term "advanced manufacturing" describes an innovative pharmaceutical manufacturing technology or approach that has the potential to improve the reliability and robustness of the manufacturing process and the resilience of the supply chain.

Stakeholders have until 1 May 2023 to submit feedback and answer eight questions at the end of the paper.

Source:

FDA