Master Batch Record vs Batch Record
The approved template vs the executed, signed proof of one batch.
What a comparison is not
A comparison is SPEQ’s reading of how two published documents differ. Neither is the right answer, it is not a determination of which applies to you, and neither is summarised in a way that replaces reading it.
The Master Batch Record (or Master Formula Record) is the approved, controlled template that defines how a product is made — the formula, process, controls, and instructions. The (executed) Batch Production Record is the completed, signed copy for one specific batch, capturing what actually happened. One is the master instruction; the other is the batch-specific evidence.
| ASPECT | MASTER BATCH RECORD | BATCH RECORD |
|---|---|---|
| What it is | The approved template/instruction for the product | The executed record of a single batch |
| How many | One controlled master per product/process | One per batch manufactured |
| Contents | Formula, process steps, in-process controls, specifications | Actual quantities, readings, times, signatures, deviations |
| Created / used | Written and approved before manufacture | Completed contemporaneously during manufacture |
| Change control | Changed only through controlled change management | Not "changed" — corrections are controlled, attributable entries |
| Role at release | The reference the batch record is checked against | Reviewed and approved as the basis for batch release |
You are working with the master batch record when you define or revise how the product is made — a single controlled template, changed only through change control.
You are working with the (executed) batch record when you manufacture and document a specific batch — the contemporaneous, signed evidence that this batch was made per the master, including any deviations.
The master is the recipe; the batch record is the receipt. Each batch is made from an accurate reproduction of the approved master, and the executed batch record proves what actually happened, entry by entry. The classic findings are a batch record that deviates from an uncontrolled master, records completed after the fact (not contemporaneously), or a master changed without change control — all of which break the chain between instruction and evidence.
Master Batch Record vs Batch Record: frequently asked questions
Common questions on how Master Batch Record and Batch Record differ and when each applies.
What is the difference between a master batch record and a batch record?
The master batch record (or master formula record) is the approved, controlled template defining how a product is made. The executed batch record (batch production record) is the completed, signed copy for one specific batch, documenting what actually happened. Master = instruction; batch record = evidence.
Can I edit the master batch record freely?
No. The master is a controlled document changed only through change control, because it defines how every batch is made. Uncontrolled changes to the master — or a batch record that silently diverges from it — are common inspection findings.
Why must the batch record be completed contemporaneously?
Because it is the evidence that controls were applied as the batch was made. Recording steps after the fact breaks contemporaneity (a core ALCOA+ principle) and undermines the record’s reliability, which is a frequent data-integrity observation.
How are corrections handled in a batch record?
Not by erasing or overwriting. Corrections are controlled, attributable entries — original entry remains legible, with the change, who made it, when, and why — preserving the audit trail per good documentation practice.