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.
What this does not cover
stated in the document's own scope- Covers GMP for human medicines; GMP for active pharmaceutical ingredients and for other product classes is set in ANVISA’s separate resolutions.
- Sets manufacturing GMP, not the product-registration pathway, which ANVISA governs through distinct registration rules.
- Is the general GMP requirement; specific dosage forms or technologies may carry additional ANVISA normative instructions.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
RDC 658/2022 is Brazil’s general Good Manufacturing Practices requirement for medicines. It sets the GMP that a manufacturer must meet to hold the GMP certification ANVISA requires, covering the pharmaceutical quality system, personnel, premises and equipment, documentation, production, quality control, qualification and validation, complaints, recalls, and outsourced activities. It replaced the earlier RDC 301/2019 and restructured Brazilian GMP around the same architecture as the PIC/S GMP Guide, so the requirements read in the familiar chapter-and-annex form used internationally.
Scope & applicability
Manufacturers supplying the Brazilian market. RDC 658/2022 provides the general GMP framework; product-specific and complementary resolutions apply separately.
Legal basis & how it acquires force
RDC 658/2022 is a Resolução da Diretoria Colegiada — a binding Collegiate Board Resolution issued by ANVISA, Brazil’s health regulatory agency, under its enabling legislation. As a resolution it carries the force of regulation for the Brazilian market. Manufacturing sites, domestic and foreign, must comply to obtain the Certificado de Boas Práticas de Fabricação (CBPF) that ANVISA requires before a medicine can be commercialised, which ties GMP compliance directly to market access.
Document structure
| Part | Covers |
|---|---|
| Pharmaceutical quality system | Quality management, quality risk management, and product quality review |
| Personnel and premises | Personnel, training, hygiene, and facility and equipment requirements |
| Documentation | The documentation system, records, and data controls |
| Production and quality control | Manufacturing operations, in-process control, and the quality-control laboratory |
| Qualification and validation | Qualification of facilities/equipment and process, cleaning, and analytical validation |
| Complaints, recalls, outsourcing | Complaint handling, recall, self-inspection, and contracted activities |
Key requirements
- Comply with the PIC/S-harmonised general GMP framework
- Maintain qualification and validation lifecycle documentation
- Apply contamination-control and PQS expectations
Implementation tips
- Confirm you are working from the current RDC 658/2022 text
Revision notes
Published 30 March 2022 (in force 2 May 2022), replacing RDC 301/2019.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
ANVISA became a PIC/S participating authority in 2021, and RDC 658/2022 is closely harmonised with the PIC/S GMP Guide — which itself mirrors EU GMP. That convergence is the point of the resolution: it aligns Brazilian GMP with the international standard so inspection outcomes are more readily comparable, while Brazil-specific procedural elements remain in ANVISA’s own normative instructions.
ANVISA RDC 658/2022: frequently asked questions
Quick answers to common questions about ANVISA RDC 658/2022.
What did ANVISA RDC 658/2022 replace?
It replaced RDC 301/2019 as Brazil’s general GMP requirement for medicines, restructuring the rules around the PIC/S GMP Guide architecture.
Is RDC 658/2022 aligned with PIC/S?
Yes. ANVISA joined PIC/S in 2021, and RDC 658/2022 is closely harmonised with the PIC/S GMP Guide, which mirrors EU GMP — part of Brazil’s convergence with international GMP.
What is the CBPF and how does it relate to RDC 658?
The CBPF (Certificado de Boas Práticas de Fabricação) is the GMP certificate ANVISA issues after inspection. A site must meet RDC 658/2022 to obtain it, and the certificate is required before a medicine can be commercialised in Brazil.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.