GMP Auditing & Consulting LLC — Reference Docket

ANVISA GMP Index (Brazil)

Brazil's RDC framework for drug and medical device GMP, organized by product category — every entry links to its source. Search by keyword or RDC number.

— entries indexed PIC/S member since 2023

Overall Index

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A GMP Auditing & Consulting LLC resource.

This library maps ANVISA's RDC (Resolução da Diretoria Colegiada) framework — Brazil's primary GMP instrument for drugs, biologics, cosmetics, and medical devices — to the product categories manufacturers build against. Brazil became a PIC/S Participating Authority in 2023, and current-generation RDCs (658/2022 for medicines, 665/2022 for devices) were written partly to support that accession, so the underlying GMP expectations increasingly mirror the EU/PIC/S/WHO harmonized text. ANVISA does not consistently publish individual RDCs at a predictable URL the way eCFR or EUR-Lex do, so most citations here link to ANVISA's official portal (gov.br/anvisa) rather than an individual resolution page; search the RDC number directly on that portal for the current consolidated text. ANVISA revises its RDCs on a rolling basis — RDC 658/2022 was itself amended by RDC 972/2025 — and we review this library periodically. Corrections welcome at gmpauditingandconsultingllc@gmail.com. This index is a navigational aid, not legal or regulatory advice.