GMPilot: An Expert AI Agent For FDA cGMP Compliance
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 ...
| Authors | Xiaohan Wang, Nan Zhang, Sulene Han et al. |
|---|---|
| Primary category | cs.AI |
| Published | 21 March 2026 |
| Last updated at source | 21 March 2026 |
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