Kosten durch fehlerhafte oder unzureichende Qualifizierung (Produktrückrufe)

Definition

Industry guidance emphasises that IQ confirms correct installation, OQ verifies functionality under controlled conditions, and PQ demonstrates consistent performance during routine production to prevent defects and ensure patient safety.[1][2][3][6] Skipping or weakening any of these stages increases the risk of contamination, equipment failure, and non-conforming product, which can lead to product recalls and regulatory penalties.[1][3][6] In the Australian context, TGA’s adoption of PIC/S GMP means that failure to adequately qualify critical equipment used in sterile or high‑risk products can drive large-scale batch rejections or recalls, with direct costs in destroyed stock, investigation, revalidation and potential compensation. For high‑value sterile injectables or specialty medicines, a single commercial batch can be worth AUD 0.5–2 million; losing several batches per year to issues ultimately traced to poorly controlled equipment or missing periodic requalification can easily drive 7‑figure annual quality loss.

Why This Matters

The Pitch: Australian 🇦🇺 pharma plants can lose AUD 1–10 million annually in rejected or recalled product traced back to equipment or process not properly qualified or maintained. Systematic, digital IQ/OQ/PQ with ongoing requalification sharply reduces these avoidable scrap and recall costs.

Affected Stakeholders

Head of Quality, Qualified Person / Authorised Person, Production Manager, Validation Manager, Supply Chain Manager, Finance Controller (COGS and write-offs)

Related Business Risks