A master batch record (MBR) — called a master production and control record in US cGMP and a master formula record in many Indian and WHO texts — is the approved, controlled template for making a product. It defines the batch size, the bill of materials with quantities and limits, theoretical yield and acceptable yield range, equipment, processing instructions, in-process controls and sampling, and the steps that need verification or signatures.
Every executed batch record is a copy of the current master, so any error in the master repeats in every batch. That is why the master itself goes through preparation, independent checking and QA approval, and why changes go through change control.
Why it matters in GMP
21 CFR 211.186 requires master production and control records for each product, prepared, dated and signed by one person and independently checked by a second. EU GMP Chapter 4 sets equivalent expectations for manufacturing formulae and processing instructions. Inspectors check that executed records match the master version that was current when the batch was made.
- Version every master and keep exactly one approved version current.
- Lock the version into each batch at the moment it is created.
- Manage changes to the master through change control.
How Swat iQua Suite handles it
Swat iQua Suite splits the master into versioned product definitions, formulas (batch size, theoretical yield and limits, and a bill of materials with target, minimum and maximum quantities) and process instruction templates (ordered steps with flags such as hold point, verification, signature and attachment). Each goes through preparer, reviewer and approver with e-signatures, only one version is approved at a time, and approving a new version supersedes the old. Batches snapshot the approved versions so they are reproducible.