Ausschuss und Nacharbeit durch unvollständige Chargenprotokolle

Definition

GMP documentation principles require that batch production records capture completion of each significant step, including dates, signatures and actual parameter values, and that deviations and out‑of‑specification (OOS) results are fully investigated and documented before batch release.[2][1] The TGA GMP guide specifies that product assessment includes review and evaluation of relevant production documentation and deviations, and that no batch is released prior to certification based on this review.[6] Where executed batch records are incomplete (missing signatures, times, results) or contain unexplained alterations, the batch cannot be legally released until issues are resolved, often requiring additional investigations, re‑sampling or re‑testing. In some cases, lack of documentation to prove compliance and traceability leads to full batch rejection or recall, even where analytical results appear acceptable.[2][6] For high‑value sterile or biological products, the cost of rework, additional QC testing and potential batch rejection can reach tens to hundreds of thousands of AUD per batch. Industry GMP literature notes that manual batch records are prone to outdated versions, missing entries and lengthy line‑by‑line QA review, which extends batch turnaround time and increases risk of documentation‑driven quality failures.[1][3]

Why This Matters

The Pitch: Pharmaceutical manufacturers in Australia 🇦🇺 can lose AUD 50,000–250,000 per year in scrap, rework and delayed release due to incomplete or inconsistent GMP batch records. Automating data capture from equipment and labs and enabling review‑by‑exception reduces avoidable batch holds and rework costs.

Affected Stakeholders

Production Supervisors, Line Operators, Quality Control Managers, Quality Assurance Batch Reviewers, Supply Chain/Planning Managers

Related Business Risks