Kosten durch Fehlbestimmung der Haltbarkeit
Definition
Shelf-life determination requires mandatory preservation stress tests (KBT) lasting 6 weeks at independent institutes, with failure causing batch rejection or rework[1][6]. Incorrect dating leads to unsellable inventory.
Key Findings
- Financial Impact: €10,000-50,000 per failed batch (test costs + rework); 2-5% inventory loss from expired stock
- Frequency: Per product batch/development cycle
- Root Cause: Manual testing delays and interpretation errors in KBT per DIN EN ISO
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Personal Care Product Manufacturing.
Affected Stakeholders
Produktionsleiter, Qualitätsmanager, Forschung & Entwicklung
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
Haltbarkeitsprüfungs-Kostenüberschreitung
Bußgelder bei falschem MHD-Angabe
Kosten der schlechten Qualität durch GMP-Verstöße
Überlaufkosten durch Abfall in Batch-Produktion
Strafen bei GMP-Auditversagen
Kapazitätsverluste durch manuelle Qualitätsprüfungen
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