Technology transfer moves a process between organizations that document differently, run different equipment and hold different assumptions. The compliance risk sits in the gap between what was transferred and what was actually known.
Transfer knowledge, not only documents
- Development history including failed approaches and why they failed
- Parameter ranges studied, not only the setpoints in the batch record
- Known process sensitivities and typical operator adjustments
- Hold times, in-process limits and the rationale behind them
- Analytical method quirks, including known interferences
Assess the receiving site honestly
Equipment differences, facility classification, utility capability, analytical capability and personnel experience should be evaluated before the protocol is written. A transfer plan that assumes equivalence rarely survives the first engineering batch.
Define success before you begin
Acceptance criteria for a transfer should be agreed by both sites and by quality in advance, with a documented plan for what happens if criteria are not met on the first attempt.