🇦🇺Australia

GMP Non-Compliance Fines for Vendor Failures

2 verified sources

Definition

TGA requires approved suppliers (preferably manufacturers, not brokers) with GMP agreements where licensed. Non-compliance in qualification leads to regulatory actions including fines and GMP clearance revocation.

Key Findings

  • Financial Impact: AUD 15,000-500,000 per TGA infringement notice (typical GMP violation penalties)
  • Frequency: Per audit failure or complaint
  • Root Cause: Inadequate documentation of qualification (e.g., missing audits, untrended test results)

Why This Matters

The Pitch: Australian packaging manufacturers risk AUD 100,000+ fines from TGA for poor vendor qualification. Automated processes ensure GMP compliance and avoid penalties.

Affected Stakeholders

Site Quality Manager, Director, 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

Cost of Poor Quality from Unqualified Vendors

AUD 20,000-100,000 per site annually in rework and testing (full sampling of 3+ lots per supplier at AUD 500-2,000 per test batch)

Excessive Testing and Audit Costs

AUD 1,000-5,000 per supplier qualification (questionnaires, 3 full tests at AUD 300-1,000 each, audit travel)

Cost of Poor Quality

AUD 10,000-50,000 per new colour project (6-8 weeks delay, scrap, rework); 2-5% production waste from mismatches[1][3][4]

Capacity Loss

AUD 5,000-10,000/week equipment idle (6-8 weeks per match); 20-40 hours/month manual delays[1][5]

Cost Overrun

AUD 2,000-5,000 per colour (test prints, pigments, pellets); 1-3% ink/supply waste[1][5][4]

Produktivitäts- und Kapazitätsverlust durch manuelles Artwork-Versionieren

Quantified (Logic): ca. 250–1.000 Stunden unnötiger manueller Koordination p.a. ≙ AUD 15,000–100,000 Kapazitätskosten pro Jahr für einen mittelgroßen Hersteller.

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