Vernichtung von kühlkettenpflichtigen Arzneimittelbeständen nach Temperaturabweichungen

Definition

The Australian code of good wholesaling practice for medicines requires that cold chain medicines be stored within the sponsor‑specified range, typically +2°C bis +8°C, with appropriate temperature monitoring equipment installed and records available to demonstrate compliance.[2][1] National and WHO‑aligned guidance makes clear that any breach of the cold chain can require discarding pharmaceutical products to protect patient safety.[1][6][9] The National Vaccine Storage Guidelines ‘Strive for 5’ specify that cold chain breaches must be reported and a breach protocol followed, including assessing whether vaccines must be discarded.[5] Where monitoring is done manually twice daily on paper charts, as per Department of Health examples, time gaps mean that the duration of an out‑of‑range event is unknown, and conservative practice is to treat exposed stock as compromised and destroy it.[6][5] For a wholesale drugs and sundries warehouse, even a single fridge or cool room excursion can mean the loss of tens of thousands of dollars of inventory (e.g. insulin, biologics, vaccines). Logic‑based estimation: a mid‑size wholesaler holding AUD 500.000 of cold‑chain stock and experiencing 1–2 significant excursions per year with 10–20 % of stock written off per event leads to AUD 50.000–200.000 annual product loss tied directly to inadequate continuous monitoring or incomplete documentation.

Why This Matters

The Pitch: Wholesale drug distributors in Australia 🇦🇺 waste bis zu AUD 100.000 pro Jahr durch vorsorgliche Vernichtung von Beständen nach nicht nachweisbar überwachten Temperaturabweichungen. Automation of continuous temperature logging, excursion alerts and compliant reporting eliminates most write‑offs.

Affected Stakeholders

Leiter Logistik / Warehouse Manager, Quality Manager (GDP), Regulatory Affairs / Compliance Manager, Pharmacist in Charge / Responsible Person, Finanzleitung / CFO

Related Business Risks