Ausschuss und Nacharbeit durch schlecht qualifizierte Lieferanten

Definition

TGA’s supplier qualification guidance for listed and complementary medicines mandates that, until a supplier is qualified, each delivery of starting or packaging material is subject to full sampling and testing by the Quality Unit before approval.[1] The document explicitly calls for analysis and trending of actual test or inspection results, including out‑of‑specification (OOS) and out‑of‑trend (OOT) outcomes, as inputs to supplier qualification decisions and periodic review.[1] It requires evaluation of supplier history and starting‑material manufacturer history, and notes that reduced sampling and testing is allowed only for suppliers that have demonstrated consistent acceptable quality.[1][7] Industry guidance on supplier qualification highlights that poor supplier oversight can result in increased deviations, OOS results, and product non‑conformances, all of which directly translate into scrap, rework and additional testing costs.[2][5] For Australian manufacturers, each rejected lot of an active or critical excipient can cost tens of thousands of AUD in material plus several thousand AUD in laboratory retesting and deviation investigation. Batch failures driven by sub‑standard raw materials can escalate the loss to hundreds of thousands of AUD per batch, especially for high‑value sterile or biological products (logic extrapolated from typical pharma cost structures and industry case studies). Ineffective tracking of supplier performance (late deliveries, OOS rate, complaint rate) also means that underperforming suppliers are not de‑qualified promptly, prolonging quality‑related losses. Where supplier‑related quality issues trigger recalls, the resulting cost overlaps with compliance penalties but originates in insufficient supplier qualification and monitoring.

Why This Matters

The Pitch: Pharmaceutical manufacturers in Australia 🇦🇺 lose an estimated AUD 200,000–1,000,000 per year in wasted materials, re‑testing and batch rework caused by poorly controlled supplier qualification and audit management. Automating supplier risk assessment, qualification status control, and performance monitoring reduces these losses by cutting OOS/OOT events at the source.

Affected Stakeholders

Quality Control Manager, Production Manager, Head of Quality / QA Manager, Supply Chain / Procurement Manager, Finance / Cost Controller

Related Business Risks