GMP Non-Compliance Audit Failures
Definition
Contract manufacturers and brands must demonstrate traceability and quality control for ISO 22716 recertification; manual processes struggle with raw material batch checks and production standardization.
Key Findings
- Financial Impact: AUD 5,000-20,000 per failed GMP audit (re-audit fees, consultant costs, production halts)
- Frequency: Annual certification audits
- Root Cause: Manual handling of quality checks without standardized tools
Why This Matters
The Pitch: Personal care product manufacturers in Australia 🇦🇺 risk AUD 10,000+ in audit rework and lost certification from manual processes. Automation ensures GMP traceability.
Affected Stakeholders
Regulatory Affairs, Quality Managers
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.
Related Business Risks
Cost of Poor Quality in Batch Production
Capacity Loss from Quality Rework
AICIS Non-Compliance Fines
ACCC Labelling Fines
TGA SUSMP Violation Penalties
AICIS Assessment & Reporting Costs
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