Product transfers between sites or to a contract manufacturer look straightforward on a plan and rarely are in practice. Most delays trace back to decisions that were never made explicitly at the start. Here are ten to settle before anything moves.
- Exact scope. Which SKUs, configurations, components and processes are moving, and which are not.
- Regulatory impact. Whether the change requires a submission or notification in each market, and how long that takes.
- Documentation readiness. Whether the device master record, specifications and work instructions are complete and current enough to transfer.
- Validation strategy. What needs installation, operational and performance qualification at the receiving site, and what can be leveraged.
- Supplier and component changes. Whether suppliers change too, and what qualification that triggers.
- Equipment and tooling. Move, duplicate or buy, with lead times confirmed.
- Bridge inventory. How much stock to build ahead so customers never see the transition.
- Labeling changes. Manufacturer address, UDI and other labeling impacts.
- People and knowledge. Training, and how tacit know-how at the sending site will be captured.
- Acceptance criteria. The yield, quality and capacity levels that define “transferred,” and who signs off.
Why this matters
Each of these is cheap to decide at planning and expensive to discover at validation. A transfer plan that answers all ten in writing, with owners, is usually a transfer that lands on time.
I lead product transfers and NPI programs for medical device manufacturers. If a transfer is on your roadmap, let’s talk.
