# GMPilot: An Expert AI Agent For FDA cGMP Compliance

arXiv: https://arxiv.org/abs/2603.20815 · HTML: https://mlsanity.com/paper/2603.20815/

## Key facts

- No citing papers in the map yet (data through 14 Oct 2026).
- Builds on 5 of its 11 references that are in the map.
- First posted on arXiv 21 Mar 2026.

## Builds on (most cited first, 5 of 5)

- [Attention Is All You Need](https://mlsanity.com/paper/1706.03762/) (2017)
- [ReAct: Synergizing Reasoning and Acting in Language Models](https://mlsanity.com/paper/2210.03629/) (2022)
- [BioBERT: a pre-trained biomedical language representation model for biomedical text mining](https://mlsanity.com/paper/1901.08746/) (2019)
- [Challenges and Applications of Large Language Models](https://mlsanity.com/paper/2307.10169/) (2023)
- [Compliance Brain Assistant: Conversational Agentic AI for Assisting Compliance Tasks in Enterprise Environments](https://mlsanity.com/paper/2507.17289/) (2025)

## Abstract (arXiv)

The pharmaceutical industry is facing challenges with quality management such as high costs of compliance, slow responses and disjointed knowledge. This paper presents GMPilot, a domain-specific AI agent that is designed to support FDA cGMP compliance. GMPilot is based on a curated knowledge base of regulations and historical inspection observations and uses Retrieval-Augmented Generation (RAG) and Reasoning-Acting (ReAct) frameworks to provide real-time and traceable decision support to the quality professionals. In a simulated inspection scenario, GMPilot shows how it can improve the responsiveness and professionalism of quality professionals by providing structured knowledge retrieval and verifiable regulatory and case-based support. Although GMPilot lacks in the aspect of regulatory scope and model interpretability, it is a viable avenue of improving quality management decision-making in the pharmaceutical sector using intelligent approaches and an example of specialized application of AI in highly regulated sectors.