Context: The Master Batch Record (MBR, master manufacturing instruction) is the approved master template for batch production. It defines manufacturing, control, materials, parameters and documentation requirements so that batches can be executed reproducibly and in line with GMP.
Why it matters: The MBR ensures consistency from batch to batch, supports traceability and forms the basis for controlled execution, QA review and subsequent batch release.
What an MBR defines:
- Product, dosage form or product description.
- Materials, components, quantities and permitted variances.
- Process steps, sequence, equipment as well as time, pressure and temperature parameters.
- Tests, specifications, acceptance criteria, packaging and labelling.
Distinction: The MBR is the approved template; the actual execution of an individual batch is documented in the batch production record or electronic batch record (eBR).
Short version: The MBR is the controlled master template for reproducible manufacturing, testing, packaging and documentation of a batch.
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