FDA seeks feedback on artificial intelligence in drug manufacturing

Regulatory NewsRegulatory News | 01 March 2023 |  By 

The US Food and Drug Administration (FDA) is soliciting feedback on how to incorporate artificial intelligence (AI) and advanced manufacturing techniques into the current regulatory framework for pharmaceutical manufacturing in a new discussion paper.
The paper, which was jointly released by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) on 1 March accompanies the agency’s release of the International Council on Harmonisation’s Q13 guideline on continuous manufacturing, which was adopted in November. (RELATED: ICH adopts Q13 guideline on continuous manufacturing, Regulatory Focus 5 December 2022)
FDA has been developing plans for incorporating AI into the medical device regulatory framework and is just beginning to look at how to apply these models in the pharmaceutical manufacturing space. (RELATED: FDA’s AI/ML action plan includes ‘tailored’ regulatory framework for SaMD, Regulatory Focus 18 January 2021)
The agency “has long supported advanced manufacturing technologies that might improve process quality and address underlying causes of drug shortages and recalls.” Such feedback will “inform future policy development” of AI.
Some examples and potential applications of AI in pharmaceutical manufacturing include Advanced Process Control (APC), which allows dynamic control of the manufacturing process to achieve a desired output.
The agency notes that “applicants may need standards for developing and validating AI models used for process control and to support release testing. AI can be used in APC applications to control manufacturing processes by adapting process parameters based on real-time data. Additionally, AI models can be used in conjunction with interrogation of in-process material or the final product to: (1) support analytical procedures for in-process or final product testing, (2) support real-time release testing, or (3) predict in-process product quality attributes.”
Yet there are “limited industry standards” and FDA guidance available in this area, “which can create challenges in establishing the credibility of a model for a specific use.”
Other areas for using AI include trend monitoring for examining consumer complaints and deviation reports containing large volumes of text. These tools can “identify cluster problem areas and prioritize areas for continual improvement.”
FDA said it wants input on using AI for cloud-based regulatory submissions, which has long been supported by agency officials. (RELATED: FDA official pushes for cloud-based regulatory assessments, Regulatory Focus 1 December 2022)
The paper also asks stakeholders to address the types of AI applications they envision being used in pharmaceutical manufacturing, and whether there are additional aspects of the current regulatory framework that may impact the implementation of AI in drug manufacturing and should be considered by FDA.
The deadline for submitting comments is 1 May 2023.
Federal Register notice
AI discussion paper


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