GMP-Auditversagen bei Lieferantenqualifizierung
Definition
Failure to properly qualify suppliers results in regulatory non-compliance, triggering fines, product holds, or market withdrawals during Betriebsprüfungen.
Key Findings
- Financial Impact: €10,000-€100,000 per GMP audit failure; 20-50 hours per onsite audit
- Frequency: Annual supplier requalification required for critical APIs
- Root Cause: Manual risk assessment and onsite audits without digital tracking
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Pharmaceutical Manufacturing.
Affected Stakeholders
Qualified Person (QP), Qualitätsmanagement, Einkauf
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
Hohe Kosten für Lieferantenaudits
Qualitätsmängel durch unqualifizierte Lieferanten
Produktionsausfälle durch Serialisierungs-Engpässe
Verzögerungen und Bürokratie in der Änderungsfreigabe
Kosten der Abweichungsuntersuchung und CAPA
Bußgelder bei CAPA-Mängeln
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