🇦🇺Australia

GMP CAPA Non-Compliance Fines

2 verified sources

Definition

Inadequate CAPA management in deviation investigations triggers TGA GMP compliance failures, resulting in batch rejections, rework, and inspection deficiencies.

Key Findings

  • Financial Impact: AUD 20,000-100,000 per GMP violation (batch rejection + rework costs); typical 2-5% production loss from deviations[3][6]
  • Frequency: Per TGA inspection or deviation event
  • Root Cause: Manual CAPA processes fail root cause analysis and timely closure, violating PIC/S standards

Why This Matters

The Pitch: Pharmaceutical players in Australia waste AUD 50,000+ annually on CAPA rework and GMP violations. Automation of deviation investigation eliminates this risk.

Affected Stakeholders

Quality Manager, Manufacturing Head, 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.

Evidence Sources:

Related Business Risks

CAPA Rework and Investigation Overheads

AUD 40 hours/month manual investigation time (at AUD 100/hr = AUD 4,000/month); 10-20% cost overrun from rework[1]

TGA Non-Compliance Fines

AUD 20,000 - 500,000 per violation; 2-5% production downtime costs

Cost of Poor Quality from Trending Failures

AUD 100,000+ per failed batch; 1-3% of production costs

Idle Capacity from Review Delays

AUD 5,000-10,000/day idle bioreactor; 5-10% capacity loss

Kosten durch TGA-GMP-Abweichungen bei Änderungsdokumentation

Estimated: AUD 70,000–250,000 per major GMP inspection cycle in extra remediation labour, consulting and TGA‑driven compliance costs due to deficient change control documentation.

Produktivitätsverlust durch manuelle Änderungsdokumentation

Estimated: 400–1,200 hours/year of QA and production time, equivalent to approximately AUD 32,000–144,000 per year in lost productive capacity due to manual change control documentation.

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