Technology transfer
Also called: Tech transfer
Moving a manufacturing process or analytical method from one site to another, such as from development to a commercial site or a CDMO.
A transfer moves the knowledge needed to make a product consistently: the process description, parameters, materials, methods, batch records and the reasons behind them. It usually ends with engineering and validation batches at the receiving site.
Decisions made during the transfer have to reach every site’s documents.
Where it goes wrong
Changes agreed by email between development and the sending site miss the receiving site’s batch record, and an engineering batch runs to the old parameters.
What Spurby does
Records each decision with its evidence, checks every site’s documents against it, and raises it for change control.
Spurby for pharmaOn our roadmap