🇦🇺Australia

TGA Non-Compliance Fines

1 verified sources

Definition

Annual product reviews identify trends in quality data; failure risks TGA enforcement including fines for GMP breaches.

Key Findings

  • Financial Impact: AUD 20,000 - 500,000 per violation; 2-5% production downtime costs
  • Frequency: Annual audits; ongoing trending required
  • Root Cause: Manual data analysis delays and errors in trending

Why This Matters

The Pitch: Pharmaceutical manufacturers in Australia 🇦🇺 waste AUD 50,000+ annually on TGA penalties and rework. Automation of annual product review trending eliminates this risk.

Affected Stakeholders

Quality Manager, Regulatory Affairs, Manufacturing Director

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

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.

Verzögerter Marktzugang durch langsame Änderungsfreigaben

Estimated: AUD 100,000–500,000 per year in cost‑of‑capital and opportunity cost from 1–5 day delays to batch release or implementation of revenue‑relevant changes caused by slow change control documentation and approval.

GMP CAPA Non-Compliance Fines

AUD 20,000-100,000 per GMP violation (batch rejection + rework costs); typical 2-5% production loss from deviations[3][6]

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