[ NATIONAL · BR ]
A national sanitary surveillance agency with its own resolutions and inspection programme.
SPEQ synthesis for orientation. It does not determine what applies to a specific product, and an adopted version can move without this page moving with it. Confirm the instrument in force with the authority before relying on it.
LATIN AMERICA
Resolução da Diretoria Colegiada RDC nº 658, de 30 de março de 2022, which sets the general guidelines for good manufacturing practices for medicines and revoked the 2019 resolution it replaced. RDC 658/2022 adopts the PIC/S good manufacturing practices guidelines as minimum requirements — an adoption by reference written into Brazilian law, and part of the reasoning behind Brazil’s PIC/S accession. It has since been amended: RDC nº 972, de 22 de abril de 2025 changed the treatment of the online control required by article 215, which may now be waived on technical justification where the company adopts alternative control strategies based on quality risk management.
Through a certificate the agency itself grants, and that expires. Good manufacturing practices in Brazil are demonstrated by a Certificado de Boas Práticas de Fabricação, which is a precondition for regulatory activity rather than a by-product of it: registration work depends on a valid certificate being in force for every manufacturing site involved, foreign sites included. The agency inspects to grant the certificate and inspects again to renew it, and it travels to inspect overseas sites supplying the market.
WHAT TRANSFERS
The standard travels; the certificate does not. Because RDC 658/2022 adopts the PIC/S guidelines as its minimum, a quality system built against PIC/S is being measured against a recognisable text rather than an unfamiliar one, and Brazil’s participation in PIC/S and ICH means an inspection outcome and a dossier from those systems are legible here. What has no substitute is the Brazilian certificate. There is no recognition route that produces one without the Brazilian agency, so the inspection has to be scheduled, hosted and passed.
Registration, post-approval change and much else downstream depend on a current certificate for each site. Planning that treats certification as a parallel workstream rather than a predecessor discovers the dependency at the worst point in a submission.
A certificate lapses on a date, and nothing about the plant has to have changed for that to happen. Recovering a lapsed certificate means re-entering an inspection queue, so the renewal date belongs on the supply plan alongside stability and campaign dates.
The obligation is the RDC; the technical content is largely the PIC/S guide it adopts. Both matter, and amendments land on the RDC — RDC 972/2025 is the current example, changing an article rather than the underlying guide.
Overseas manufacturers supplying Brazil are subject to inspection by the Brazilian agency. For a company whose other markets accept documentation, this is often the first regulator that arrives in person, and readiness expectations should be set accordingly.
RDC nº 658, de 30 de março de 2022 — the general guidelines for good manufacturing practices for medicines. It revoked the 2019 resolution and adopts the PIC/S good manufacturing practices guidelines as minimum requirements. It was amended by RDC nº 972, de 22 de abril de 2025.
No. Participation makes evidence from other participating authorities legible and supports the assessment, but good manufacturing practices in Brazil are demonstrated through a certificate the Brazilian agency issues. There is no recognition route that produces that certificate without them.
Because the certificate is a precondition for regulatory activity rather than a record of past compliance. When it lapses, registration work that depends on it stops — for a site that is operating normally — and recovering it means re-entering the inspection queue.
ADOPTED, AT A PINNED VERSION
SPEQ has not decoded a pinned adoption edge here yet. That is a gap in this catalog, not a finding about Brazil: requirements still arrive through the authorities below, and the edition in force is theirs to state.
Participation changes which evidence transfers, and which edition of a harmonized guide the local instrument is likely to pin.