About GMP Bench
What is GMP Bench?
GMP Bench is an open benchmark designed to evaluate large language models on tasks relevant to pharmaceutical Good Manufacturing Practice (GMP). It measures how well models understand regulatory requirements, generate compliant documentation, and assist with quality-critical decisions in GMP-regulated environments.
The benchmark covers two primary domains: knowledge-based question answering across regulatory frameworks (ICH, FDA, EU GMP, and pharmacopeias) and task completion involving the generation of SOPs, deviation reports, CAPA plans, and other GMP documents.
Why This Matters
Pharmaceutical manufacturing operates under strict regulatory oversight. Errors in documentation, deviations from procedure, or misinterpretation of guidelines can lead to product recalls, warning letters, or patient safety risks. As organizations explore the use of LLMs to assist with GMP activities, there is a clear need for objective, domain-specific evaluation.
General-purpose benchmarks do not capture the nuances of pharmaceutical regulation. GMP Bench fills this gap by providing test cases authored and reviewed by industry professionals, scored against verified reference material.
How Scoring Works
Knowledge QA
Knowledge questions are evaluated by comparing the model's response against a verified reference answer. Scoring considers factual accuracy, completeness, and correct citation of regulatory sources. Each response receives a normalized score from 0 to 1.
Task Completion (LLM-as-Judge)
Task outputs—such as generated SOPs or deviation reports—are evaluated using an LLM-as-judge approach. A separate evaluation model scores the output against a rubric that assesses accuracy, regulatory alignment, completeness, and structural quality. This method enables scalable evaluation of open-ended generation tasks while maintaining consistency.
Overall Score
A model's overall score is the average across all evaluated test cases. Category-specific scores (e.g., Knowledge QA, Task Completion) are also available for more targeted comparison.
How to Contribute
GMP Bench is a community-driven project. Pharmaceutical professionals can contribute in several ways:
- Submit test cases — Propose knowledge questions or task scenarios based on real-world GMP challenges.
- Review submissions — Vote on proposed test cases to help curate the benchmark.
- Provide feedback — Report issues with scoring, suggest new categories, or propose improvements to the evaluation methodology.
Contact
For questions, partnership inquiries, or feedback, reach out via the project's GitHub repository or contact the maintainers directly. We welcome collaboration with pharmaceutical companies, regulators, and AI researchers working on GMP applications.