Kosten für CPSR-Nacharbeiten und Stabilitätsfehler
Definition
CPSR requires detailed stability testing and formula safety evidence; failures lead to rework and liability for the Responsible Person.[1][3][6]
Key Findings
- Financial Impact: 20-50 hours rework per product (€2,000-€5,000 at €100/hr) + warranty claims
- Frequency: Per product development cycle
- Root Cause: Manual formula iterations without real-time stability simulation
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Personal Care Product Manufacturing.
Affected Stakeholders
Chemiker, Labormanager, Responsible Person
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
Bußgelder für nicht konforme Formeln (CMR-Stoffe)
Überhöhte Kosten für PIF-Archivierung und Stabilitätstests
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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