Hohe Kosten für Lieferantenaudits und Qualifikation
Definition
GMP mandates detailed audits, risk assessments, and ongoing monitoring for suppliers of raw and packaging materials, driving high manual costs without automation.
Key Findings
- Financial Impact: 20-50 Stunden/Monat pro Auditor; €5.000-€15.000/Jahr pro kritischen Lieferant
- Frequency: Jährlich für Re-Qualifikation; bei Änderungen sofort
- Root Cause: Manuelle Audits, Dokumentenprüfungen und Risikobewertungen ohne Software-Unterstützung
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Packaging and Containers Manufacturing.
Affected Stakeholders
Qualitätsmanager, Qualified Person (QP), 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
Kosten durch Qualitätsmängel unqualifizierter Rohstoffe
Bußgelder durch GMP-Widrigkeiten bei Lieferantenmanagement
Leerlauf durch falsche Artwork-Versionen
Changeover-Zeit und Ausfallzeiten
Kosten durch Farbabweichungen und Nacharbeiten
Upgrade-Kosten für RoHS-konforme Beleuchtung
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