What Brazil ANVISA Good Manufacturing Practices RDC 658/2022 - Pharmaceutical GMP, AFE Certification and Inspection requires
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…
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Pillar: Pharmaceuticals & Life Sciences · Authority: Agencia Nacional de Vigilancia Sanitaria (ANVISA); Ministry of Health, Brazil · Version: 1.0.0 · Last updated:
Primary source: https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-658-de-30-de-marco-de-2022-389657293
SHA-256 integrity: d4d235920c63fe6365107c68f3e4ab6b25465a93c5b883543614ba023333ad90
Primary Citations — 6 traced to source
- 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) — RDC 658 de 30 de marco de 2022 - Boas Praticas de Fabricacao de Medicamentos - ANVISA
- 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 — ANVISA - Boas Praticas de Fabricacao (BPF) - Medicamentos
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