Master batch records

A master batch record (MBR) is the approved template for making a product. Every production run copies from it, so the master is where you define and control the standard process.

What goes in a master

• The procedure — the ordered manufacturing instructions.
• The materials and quantities, usually pulled from the product’s BOM.
• The in-process checks and data the operator must record.
• The sign-offs required to perform and verify each step.

Create a master batch record

1. Choose the product the master applies to.
2. Add the procedure steps and attach the materials consumed at each one.
3. Define data-entry fields, checks, and required sign-offs.
4. Review the draft and approve it to make it usable for production.

Treat the master as a controlled document. Approve a master before it can be used, and use versioning so you can see exactly which template made any past batch.

Versioning and changes

When a process changes, create a new version of the master rather than editing the live one. Issued batches always reference the version they were created from, so historical records stay accurate even after the master evolves.

Editing a master never alters batches already in progress or completed — it only affects records created afterward.

Next steps

With an approved master in place, generate an issued batch record to run production.