Kosten durch mangelhafte Seriennummern- und Rückverfolgbarkeitsdaten

Definition

Australia has started moving toward pharma serialization and a more comprehensive track‑and‑trace system. Therapeutic Goods (Medicines—Standard for Serialization and Data Matrix Codes) Order 2021 (TGO 106) recommends that from January 2023 certain medicines be serialized and equipped with a GS1‑standard DataMatrix including GTIN, batch number, expiry date and serial number.[5] Although serialization is currently optional, it signals an expectation that manufacturers and their supply‑chain partners will use unique identifiers to support product verification and traceability. If wholesalers do not reliably scan, store and reconcile these identifiers at each custody transfer, they lose the ability to narrow issues to specific serials or batches. LOGIC: When a safety issue or quality defect is detected, a wholesaler with incomplete pedigree data cannot confidently identify which individual packs or customers are impacted, and must therefore broaden the scope of recalls. For example, instead of recalling 5% of stock tied to a specific serial range, the company may recall 100% of shipments over a period. In a medium wholesaler handling, say, AUD 5 million of affected products annually, an unnecessarily broad recall affecting even 10–20% of value can result in AUD 500,000–1,000,000 of product returns, write‑offs and credit notes. Conservatively attributing only a fraction of this to documentation failure (e.g. 10–20% of loss) yields AUD 50,000–200,000 per major recall attributable to poor serialization capture, along with extra labour for manual investigations and reconciliation. The lack of robust chain‑of‑custody documentation also increases the cost of investigating suspected counterfeit or diverted product incidents.

Why This Matters

The Pitch: Wholesale Drugs and Sundries distributors in Australia 🇦🇺 waste an estimated AUD 50,000–200,000 per major recall on manual investigations, over‑inclusive recalls and write‑offs caused by poor serialization and chain‑of‑custody data. Automation of GS1 DataMatrix scanning and electronic pedigree management sharply reduces these quality costs.

Affected Stakeholders

Quality Assurance Manager, Regulatory Affairs Manager, Supply Chain / Logistics Manager, Warehouse Manager, Head of Operations, Chief Financial Officer

Related Business Risks