BfArM-Strafen bei GMP-Änderungsfehlern
Definition
In Germany, BfArM enforces strict GMP change control during inspections; poor records result in citations, rework mandates and market withdrawal risks.
Key Findings
- Financial Impact: €50,000+ pro GMP-Behördenmaßnahme; €250,000+ für Produktionsstopp
- Frequency: Bei Betriebsprüfung (alle 3-5 Jahre)
- Root Cause: Unvollständige Dokumentation, fehlende Risikobewertung
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Pharmaceutical Manufacturing.
Affected Stakeholders
Compliance Director, Site Quality Head, Regulatory Affairs
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
Verzögerungen und Bürokratie in der Änderungsfreigabe
Kosten durch Qualitätsmängel bei Änderungskontrollen
Produktionsausfälle durch Serialisierungs-Engpässe
Kosten der Abweichungsuntersuchung und CAPA
Bußgelder bei CAPA-Mängeln
Überstunden in CAPA-Prozessen
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