{
  "node_id": "brazil-anvisa-good-manufacturing-practices-rdc-658-2022",
  "title": "Brazil ANVISA Good Manufacturing Practices RDC 658/2022 - Pharmaceutical GMP, AFE Certification and Inspection",
  "domain": "Pharmaceuticals & Life Sciences",
  "version": "1.0.0",
  "last_updated": "2026-05-09",
  "bluf": "Brazil's Resolucao da Diretoria Colegiada RDC 658 of 30 March 2022 (ANVISA Good Manufacturing Practices for Medicines) established updated GMP requirements for finished pharmaceutical products aligned with ICH Q10 Pharmaceutical Quality…",
  "paywall": {
    "status": "LOCKED",
    "unlock_cost_usd": "0.01",
    "skyfire_id": "41779894-ece2-4163-9761-b3b1b76e19b0"
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  "crosswalks": {
    "_available_keys": [
      "related_frameworks",
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    ],
    "_note": "Full crosswalk values included in vault response"
  },
  "dependencies": [
    "brazil-anvisa-resolution-rdc-204-2017"
  ],
  "primary_citations_count": 6,
  "workflow_steps_count": 9,
  "schema_fields_count": 18,
  "citation_preview": [
    {
      "title": "RDC 658 de 30 de marco de 2022 - Boas Praticas de Fabricacao de Medicamentos - ANVISA",
      "url": "https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-658-de-30-de-marco-de-2022-389657293",
      "section": "Chapter 1 (Pharmaceutical Quality System - ICH Q10 alignment); Chapter 4 (Manufacturing operations - batch records, deviations, yield reconciliation); Chapter 5 (Supplier qualification); Chapter 6 (Quality Control laboratory - validation, stability); Chapter 8 (Complaints and product recall - 15-day notification, recall scope levels); Chapter 13 (Change control - ICH Q9 risk assessment)"
    },
    {
      "title": "ANVISA - Boas Praticas de Fabricacao (BPF) - Medicamentos",
      "url": "https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/boas-praticas-de-fabricacao",
      "section": "CBPF application process; ANVISA GMP inspection programme; GGFAR coordination; site master file requirements; CBPF categories by dosage form; inspection classification (critical, major, minor findings); CBPF validity 2 years"
    }
  ]
}