🇦🇺Australia

Serialization Implementation Costs

3 verified sources

Definition

Manufacturers face costs for serialization hardware, software, and consulting to meet TGO 106, with pilots in 2024 and mandatory 2025 leading to rush orders and waste.

Key Findings

  • Financial Impact: AUD 200,000 - 1,000,000 per production line (hardware/software); 30-60 hours/month validation.
  • Frequency: One-time setup + annual maintenance.
  • Root Cause: Idle equipment during upgrades, unnecessary supplies for non-GS1 compliant trials.

Why This Matters

The Pitch: Pharmaceutical players in Australia spend AUD 200,000 - 1M per site on TGO 106 serialization setups. Automation streamlines hardware integration and cuts overruns.

Affected Stakeholders

Operations Managers, IT/Systems Integrators, Procurement

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

TGA Non-Compliance Penalties

AUD 50,000 - 500,000 per violation (TGA civil penalties); 20-50 hours/month manual compliance per line.

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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