Batch Manufacturing Record (BMR)
The authorised document for a batch, completed as the batch is made, recording every material, parameter, check and signature — the primary evidence that a batch was made as approved.
Contemporaneous or worthless
Entries made after the fact are the single most common serious audit finding. The record is completed at the step, by the person who performed it, with a second signature where the process requires verification.
What travels with the batch
Executed BMR, deviation and investigation records, environmental and in-process data, analytical release results, and the certificate of analysis and compliance.
Related terms
Where this applies
General Injectables
Need help applying this?
Stancor Pharma engineers answer specification questions directly. Contact us.