Brazilian Good Manufacturing Practices for Medicines
Brazil's general GMP requirements for medicines (Collegiate Board Resolution RDC 658/2022), which replaced RDC 301/2019 and is closely harmonised with PIC/S GMP. ANVISA became a PIC/S member in 2021, driving convergence with international GMP.
Manufacturers supplying the Brazilian market. RDC 658/2022 provides the general GMP framework; product-specific and complementary resolutions apply separately.
- 01Comply with the PIC/S-harmonised general GMP framework
- 02Maintain qualification and validation lifecycle documentation
- 03Apply contamination-control and PQS expectations
Published 30 March 2022 (in force 2 May 2022), replacing RDC 301/2019.
ANVISA RDC 658/2022: frequently asked questions
Quick answers to common questions about ANVISA RDC 658/2022.
What is ANVISA RDC 658/2022?
ANVISA RDC 658/2022 — Brazilian Good Manufacturing Practices for Medicines — is a regulation issued by the Agência Nacional de Vigilância Sanitária (Brazil). Brazil's general GMP requirements for medicines (Collegiate Board Resolution RDC 658/2022), which replaced RDC 301/2019 and is closely harmonised with PIC/S GMP. ANVISA became a PIC/S member in 2021, driving convergence with international GMP.
Who does ANVISA RDC 658/2022 apply to?
Manufacturers supplying the Brazilian market. RDC 658/2022 provides the general GMP framework; product-specific and complementary resolutions apply separately.
What are the key requirements of ANVISA RDC 658/2022?
ANVISA RDC 658/2022 requires, among other things: Comply with the PIC/S-harmonised general GMP framework; Maintain qualification and validation lifecycle documentation; Apply contamination-control and PQS expectations.
When was ANVISA RDC 658/2022 last updated?
The current version of ANVISA RDC 658/2022 dates from May 2022. Published 30 March 2022 (in force 2 May 2022), replacing RDC 301/2019.
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When ANVISA RDC 658/2022 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.