Produktionskapazitätsverlust durch manuelle IQ/OQ/PQ-Abwicklung

Definition

Guidance on equipment qualification stresses multiple structured steps (URS, DQ, IQ, OQ, PQ, review and approval of reports) and states that all documentation must be approved and authorised by appropriate personnel before equipment is released.[1][3][5][4] In practice, when these steps are executed on paper or in basic office tools, each review/approval cycle can take days or weeks, especially when quality, engineering and production are not aligned. During this time, newly installed or upgraded lines often cannot produce GMP product, creating idle assets and pushing revenue later. Given Australian labour and facility costs, a mid‑size oral solid dose or sterile line can easily represent AUD 100k–150k of contribution margin per operating day. If manual IQ/OQ/PQ execution and approval add 10–30 unnecessary idle days over the project, that alone represents a significant, though often hidden, capacity loss.

Why This Matters

The Pitch: Australian 🇦🇺 pharma sites routinely lose 10–30 production days per new or modified line waiting for IQ/OQ/PQ paperwork and approvals. At typical line values, this equals AUD 1–4.5 million in lost output per major project. Digital validation workflow and template reuse can cut this idle time by 30–50%.

Affected Stakeholders

Engineering / Capital Projects Manager, Validation Manager, Head of Manufacturing, Site Planning / Supply Chain Manager, Finance / CFO (capex ROI and asset utilisation)

Related Business Risks