Verzögerter Marktzugang durch langsame Änderungsfreigaben

Definition

Australian GMP guidance integrates change control into product specification files and batch records, requiring that all planned changes, deviations and consequent tests are documented and available to the Authorised Person when certifying each batch.[4] Change control in pharma covers initiation, QA assessment, analysis and approval, implementation and closure, with all steps documented for regulatory purposes.[3] When documentation is incomplete, Authorised Persons cannot certify batches, and implementation of process optimisations or new capacity often waits until documentation is finalised and approved. This extends the cycle time between manufacturing, batch release and invoicing. Logical estimation for a medium‑size Australian site releasing high‑value prescription medicines: if slow change control delays batch release or implementation of a new line by 1–5 days on 10–20 key batches or launches per year, and each such batch represents AUD 1–5 million of revenue, the cost of capital and lost opportunity from delayed cash inflow can reach AUD 100,000–500,000 per year (assuming a conservative 5–10% annual cost of capital and margin on delayed revenue).

Why This Matters

The Pitch: Pharmaceutical manufacturers in Australia 🇦🇺 lose 1–5 days of time‑to‑cash on affected batches and product launches because change control documentation and approvals are not streamlined. Automating impact assessment, approvals and linkage to batch release can recover AUD 100,000–500,000 in earlier cash inflows annually for medium‑to‑large plants.

Affected Stakeholders

Qualified Person / Authorised Person, Supply Chain and Planning Managers, Site Head / General Manager, Regulatory Affairs, Commercial / Finance teams monitoring revenue timing

Related Business Risks