Kosten der mangelnden Qualität durch Stabilitätsfehler
Definition
Failure to detect small incremental variations in stability data across production batches results in out-of-specification results, rework, and regulatory non-compliance.
Key Findings
- Financial Impact: €100,000 - €1M per failed batch rejection; 2-5% of production costs in rework
- Frequency: Per production batch or annually during stability monitoring
- Root Cause: Manual trend analysis misses subtle drifts in multi-batch stability data
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Pharmaceutical Manufacturing.
Affected Stakeholders
QA Manager, Stability Study Coordinator, 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
Kostenüberschreitungen durch manuelle Stabilitätsstudien
Kapazitätsverluste durch Stabilitätsengpässe
Bußgelder durch Stabilitäts-Nichtkonformität
Produktionsausfälle durch Serialisierungs-Engpässe
Verzögerungen und Bürokratie in der Änderungsfreigabe
Kosten der Abweichungsuntersuchung und CAPA
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