Kosten der schlechten Qualität durch Batch Record Fehler
Definition
Manual batch record reviews in GMP processes frequently identify issues like missing signatures, unrecorded steps, data errors, and unresolved deviations, leading to batch holds, investigations, and rework. In pharmaceuticals, a single rejected batch can cost €100,000+ in materials, labor, and delays.
Key Findings
- Financial Impact: €50,000-€200,000 pro Jahr pro Site (Rework + Batch Rejection); 20-40 Stunden pro Batch Review
- Frequency: Bei jedem Batch (täglich/wöchentlich)
- Root Cause: Manuelle Reviews anfällig für menschliche Fehler; fehlende Echtzeit-Überwachung
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Pharmaceutical Manufacturing.
Affected Stakeholders
QA Reviewer, Production Supervisor, Qualified Person (QP)
Deep Analysis (Premium)
Financial Impact
Financial data and detailed analysis available with full access. Unlock to see exact figures, evidence sources, and actionable insights.
Current Workarounds
Financial data and detailed analysis available with full access. Unlock to see exact figures, evidence sources, and actionable insights.
Get Solutions for This Problem
Full report with actionable solutions
- Solutions for this specific pain
- Solutions for all 15 industry pains
- Where to find first clients
- Pricing & launch costs
Methodology & Sources
Data collected via OSINT from regulatory filings, industry audits, and verified case studies.
Related Business Risks
Übermäßige Personalkosten für Batch Record Reviews
GMP-Verstöße durch unvollständige Batch Records
Produktionsausfälle durch Serialisierungs-Engpässe
Verzögerungen und Bürokratie in der Änderungsfreigabe
Kosten der Abweichungsuntersuchung und CAPA
Bußgelder bei CAPA-Mängeln
Request Deep Analysis
🇩🇪 Be first to access this market's intelligence