🇦🇺Australia

TGA Non-Compliance Penalties

3 verified sources

Definition

TGO 106 sets standards for serialization and DataMatrix codes, optional since Jan 2023 but moving to mandatory for prescription medicines in 2025 with audits and penalties for non-compliance in 2028. Failure risks fines under TGA enforcement powers.

Key Findings

  • Financial Impact: AUD 50,000 - 500,000 per violation (TGA civil penalties); 20-50 hours/month manual compliance per line.
  • Frequency: Per non-compliant batch release; annual audits from 2028.
  • Root Cause: Manual serialization errors, lack of aggregation software, failure to meet GS1 standards.

Why This Matters

The Pitch: Pharmaceutical manufacturers in Australia waste AUD 100,000+ annually on TGO 106 penalties and rework. Automation of serialization and reporting eliminates this risk.

Affected Stakeholders

Manufacturing Managers, Quality Assurance, Supply Chain Directors, Compliance Officers

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Financial Impact

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Methodology & Sources

Data collected via OSINT from regulatory filings, industry audits, and verified case studies.

Evidence Sources:

Related Business Risks

Serialization Implementation Costs

AUD 200,000 - 1,000,000 per production line (hardware/software); 30-60 hours/month validation.

Track-and-Trace Bottlenecks

5-10% production capacity loss (AUD 500,000+ / year per site); 10-20 hours/week idle equipment.

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.

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