GMP Auditing & Consulting LLC — Reference Docket

EU GMP Regulatory Index

EudraLex Volume 4 (Parts I–IV and Annexes) plus related EU legislation, organized by product category — every entry links to its source. Search by keyword or citation.

— entries indexed Reflects Annex 1 (2022) & Annex 21 (2022)

Overall Index

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A GMP Auditing & Consulting LLC resource.

This library maps EudraLex Volume 4 (Parts I–IV and Annexes) and related EU legislation to the product categories manufacturers build against, including the 2022 revisions to Annex 1 (sterile manufacturing) and Annex 21 (importation). EudraLex Volume 4 is maintained by the European Commission (DG SANTE) and is legally binding under Article 47 of Directive 2001/83/EC. Annex and chapter citations link to the official EudraLex Volume 4 portal; EU legislation citations link to the exact EUR-Lex record. The Commission revises annexes on a rolling basis — Annex 11, Chapter 4, and a new Annex 22 on artificial intelligence are in consultation as of 2026 — and we review this library periodically. Corrections welcome at gmpauditingandconsultingllc@gmail.com. This index is a navigational aid, not legal or regulatory advice.