GxP AI assistant

Answers to GxP and GMP regulatory questions, with citations.

Ask natural-language questions about FDA or EU GMP, GCP, GLP, GDP, GVP, CSV, Data Integrity, 21 CFR Part 11, ICH guidelines and more. GxPAnswers cites the specific clause every time.

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Cited answers.

Every response points to the specific clause, chapter, or guideline it draws from.

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Answers structured for inspection prep, SOP drafting, and cross-referencing.

Regulatory scope.

Covers GMP, GCP, GLP, GDP, GVP, CSV, Data Integrity, pharmacovigilance and device regulations.

Coverage

Grounded in the frameworks you actually cite.

FDA

21 CFR Parts 4, 11, 50, 54, 56, 58, 210–213, 312, 600, 606, 610, 630, 640, 803, 806, 812, 820, 1271; selected guidance

EU GMP

Part I Chapters 1–9; Annexes 1, 2, 11, 13, 15, 16, 17, 19, 21; draft Chapter 4 and Annexes 11, 22

ICH

Q1 (Q1A–Q1F series), Q2(R2), Q7, Q8(R2), Q9(R1), Q10–Q14, E6(R3)

PIC/S

PE 009-17 Part I and Annexes; PI 006-3, PI 011-3, PI 041-1

Frequently asked questions

What does GxPAnswers cover?

FDA 21 CFR (the parts listed in the Coverage section) and selected guidance, EU GMP Part I Chapters 1–9 and the listed Annexes, ICH Q-series and E6(R3), and PIC/S PE 009-17 plus the listed PI documents.

How are answers cited?

Every response points to the specific clause, chapter or guideline it draws from.

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Can I rely on the answers?

GxPAnswers is informational only. Always verify against the official regulatory texts.

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