GMPilot: An Expert AI Agent For FDA cGMP Compliance

TL;DR

GMPilot is an AI agent designed to assist pharmaceutical quality professionals in complying with FDA cGMP regulations by providing real-time, traceable decision support through retrieval-augmented generation and reasoning frameworks.

Contribution

The paper introduces GMPilot, a novel AI system that leverages a curated knowledge base and advanced frameworks to enhance compliance support in pharmaceutical quality management.

Findings

Improves responsiveness of quality professionals during simulated inspections.

Provides structured, verifiable regulatory and case-based support.

Demonstrates viability of AI in highly regulated pharmaceutical sector.

Abstract

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.