Kosten für Qualitätsmängel durch fehlende IQ/OQ/PQ
Definition
Failure to properly execute IQ/OQ/PQ results in non-compliant equipment, leading to product defects, batch failures, and regulatory interventions.
Key Findings
- Financial Impact: €100,000 - €1M per recall event; 5-10% production downtime costs
- Frequency: Per non-compliant batch or inspection failure
- Root Cause: Inadequate documentation, uncalibrated equipment, skipped performance tests
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Pharmaceutical Manufacturing.
Affected Stakeholders
Qualitätsmanager, Produktionsleiter, Compliance Officer
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
Überhöhte Kosten durch manuelle IQ/OQ/PQ-Prozesse
BfArM-Strafen bei IQ/OQ/PQ-Mängeln
Kapazitätsverluste durch IQ/OQ/PQ-Verzögerungen
Produktionsausfälle durch Serialisierungs-Engpässe
Verzögerungen und Bürokratie in der Änderungsfreigabe
Kosten der Abweichungsuntersuchung und CAPA
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