Master batch record (MBR)
Also called: MBR
The approved, controlled instructions for making a batch of a product: materials, equipment, steps, parameters and checks.
Each batch is made from a copy of the master batch record, completed during production as the executed batch record. Changes to the master go through document control and change control.
During a transfer, each site’s batch record has to reflect what was agreed.
Where it goes wrong
A parameter agreed on a transfer call sits in the minutes while the batch record still has the old value.
What Spurby does
Checks each site’s batch record drafts against what was agreed, and flags the step that differs.
Spurby for pharmaOn our roadmap