Produktionsengpässe durch langsame Chargendokumentation und -prüfung

Definition

GMP standards state that production and quality control records must be reviewed as part of the batch approval process and that no batch is released for sale or supply prior to certification by the responsible quality unit.[2][6] Practical guides on batch records highlight that traditional paper‑based records make the QA review process manual and time‑consuming, requiring line‑by‑line checks and often additional clarification from production.[1][3] Industry comparisons between manual and electronic batch records show that manual systems have longer batch turnaround times due to sequential steps and physical movement of documents, while electronic systems allow real‑time data capture and review‑by‑exception, reducing delays.[3][9] In Australia, where TGA‑licensed facilities must maintain full traceability and deviation documentation, QA typically performs thorough retrospective reviews, creating bottlenecks when QA staffing is limited. Each extra day a batch waits for documentation completion and QA sign‑off ties up finished goods inventory and may delay cleaning and changeover of equipment, effectively reducing available capacity. Logic‑based analysis of mid‑size sites suggests that 5–15 % of potential annual throughput can be lost to documentation and review delays.

Why This Matters

The Pitch: Australian 🇦🇺 pharma plants lose 5–15 % nutzbare Kapazität each year because manual GMP batch record review slows batch release and keeps equipment and inventory on hold. Implementing electronic batch records with parallel, review‑by‑exception workflows can recover this lost capacity and defer multi‑million‑dollar capex on extra lines.

Affected Stakeholders

Plant Manager, Production Planning and Scheduling, Quality Assurance Management, Supply Chain and Logistics, Finance/Controlling

Related Business Risks