Multas ANVISA por Falha em Cadeia Fria
Definition
Failure to provide documented evidence of thermal performance during transport of temperature-sensitive drugs results in regulatory non-compliance, requiring expensive qualification studies and risking penalties.
Key Findings
- Financial Impact: R$50,000+ per qualification study/report; fines for non-compliance up to 2% of revenue per violation
- Frequency: Per shipment/audit cycle
- Root Cause: Manual temperature logging without sufficient recorders or digital validation
Why This Matters
The Pitch: Wholesale Drugs players in Brasil waste R$50,000+ annually on Anvisa qualification reports and fines. Automation of temperature monitoring eliminates qualification risks.
Affected Stakeholders
Gerente de Qualidade, Coordenador Logístico, Auditor ANVISA
Deep Analysis (Premium)
Financial Impact
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Current Workarounds
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Methodology & Sources
Data collected via OSINT from regulatory filings, industry audits, and verified case studies.
Related Business Risks
Perda de Produtos por Excursão Térmica
Custos Excessivos de Qualificação Térmica
Multas ANVISA por Falta de Rastreabilidade de Medicamentos
Custos Extras com Sistemas Manuais de Serialização
Perda de Capacidade por Atrasos em Validação de Serialização
Multas por Não Cumprimento da Logística Reversa de Medicamentos
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