GMP batch release · deviations · FDA/EMA precedent
ChatQP is a local AI decision-support tool for pharmaceutical quality and regulatory teams. It runs on a curated regulatory corpus — not a general chatbot — applies hard GMP (Good Manufacturing Practice) rules outside the model, and returns a structured, source-cited assessment to review.
In plain terms: it helps Qualified Persons (QPs — the people legally accountable for releasing each batch in the EU), QA leads and regulatory-affairs teams make and defend GMP decisions, entirely on their own hardware.
Two capability areas: batch release & deviations, and Regulatory Intelligence — source-linked FDA/EMA (European Medicines Agency) precedent for regulatory and CMC (Chemistry, Manufacturing and Controls) teams.
What it does
For QA and QP work: it classifies the quality problem, searches the strongest regulatory sources first, applies hard GMP rules in code, weighs FDA and EU enforcement precedent, and returns a structured position to review — with the basis, the key risks, and the open questions. See the benchmark outputs.
See benchmarks →For regulatory-affairs and CMC teams: an integrated advisory capability that reads public EMA assessment reports and FDA reviews and turns them into precedent you can trace to the source page — control strategies, analytical techniques, and variation history. Advisory only; it does not predict acceptance.
Explore Regulatory Intelligence →It classifies the problem, retrieves the strongest sources, applies the hard rules outside the model, and hands a structured position to the human. Every output keeps a visible reasoning trace and cites where each point comes from. Nothing is processed in the cloud.
See how it works →How ChatQP frames the outcome
ChatQP never certifies a batch. It states one of four positions for the QP to review — wording that says whether certification is supported, never whether the batch is released.
All requirements are met. The QP can certify, with the regulatory basis stated.
Supportable once a documented, bounded justification and the listed actions are in place.
An open concern blocks certification until it is investigated. A specific path forward is given.
A hard GMP rule was triggered. No risk-based argument overrides it.
Built around the draft EU GMP Annex 22 — the EU's emerging expectations for using AI in pharmaceutical manufacturing and quality systems: hard rules in code, source-cited outputs, a full reasoning trace, and nothing processed in the cloud. Read the governance approach →
Interested in testing ChatQP with constructed GMP scenarios? The system is in private beta.
Request AccessFinal batch certification remains the legal responsibility of the Qualified Person under EU GMP Annex 16. All ChatQP outputs are decision-support material, subject to QP review.