Kosten durch GMP-Non-Compliance bei Qualifizierung (IQ/OQ/PQ)

Definition

TGA follows the PIC/S Guide to GMP (PE009), including Annex 15 on qualification and validation, which requires that all qualification and validation documents are pre-approved, executed by trained personnel, and maintained over the lifecycle.[4][8] When equipment qualification (IQ/OQ/PQ) is incomplete, not current, or poorly documented, TGA can classify findings as major or critical, trigger conditions on the GMP licence, require revalidation, or in severe cases restrict or suspend manufacturing, which directly converts into lost production days and emergency consulting costs.[4][8] Given the cost of an Australian commercial pharma line (often AUD 100k–300k per day of output), even a short restriction while deficiencies are fixed can easily amount to AUD 0.5–1.5 million of lost margin plus 5– or 6‑figure remediation projects with validation consultants and overtime for internal staff. This is a predictable money bleed whenever IQ/OQ/PQ is managed manually across paper, spreadsheets and email instead of controlled digital workflows.

Why This Matters

The Pitch: Pharmaceutical manufacturers in Australia 🇦🇺 risk losing AUD 0.5–3 million per inspection cycle on rework, remediation and lost sales from Annex 15 deficiencies in IQ/OQ/PQ. Automation of validation planning, execution tracking and documentation integrity eliminates most of this risk.

Affected Stakeholders

Head of Quality / Qualified Person (Authorised Person), Validation Manager / CSV Manager, Engineering Manager, Manufacturing Manager, Regulatory Affairs Manager, Site General Manager

Related Business Risks