Pharmaceutical Batch Manufacturing Record (BMR) Template
A batch manufacturing record (BMR) is the controlled document that proves a batch was made exactly as the master formula and process describe. This template gives you a clean executed-record layout with line clearance, material dispensing, step log, in-process controls, yield reconciliation and review signatures.
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Pharmaceutical Batch Manufacturing Record Template
Batch Manufacturing Record
Company / site: Meridian Pharma Ltd, Solid Dosage Block Product: Metformin Hydrochloride Tablets 500 mg Product code: MET-500-T Batch number: B26-1042 Batch size: 300,000 tablets (186.0 kg blend) Master record reference: MBR-MET-500 Rev 04 Manufacturing start: 2026-10-20 Expiry: 10/2028 Area: Granulation Room G2, Compression Suite C1
Pre-start line clearance
| Check | Yes / No / NA | Done by | Verified by |
|---|---|---|---|
| Previous product and labels removed | |||
| Room and equipment cleaned, status label current | |||
| Balances and gauges within calibration | |||
| Room temperature, humidity and differential pressure recorded |
Material dispensing
| Material | Lot / AR number | Theoretical qty | Actual qty | Dispensed by | Checked by |
|---|---|---|---|---|---|
| Active ingredient | |||||
| Diluent | |||||
| Binder | |||||
| Disintegrant | |||||
| Lubricant |
Process steps
1. Dispense and verify materials. 2. Sift API and excipients through 20 mesh. 3. Dry blend 15 minutes. 4. Granulate with binder solution, dry to LOD 1.5 to 2.5 percent. 5. Mill, lubricate 3 minutes. 6. Compress to target weight. 7. Film coat. 8. Bulk hold and sample.
Process step execution log
| Step | Equipment ID | Parameters actual | Start | End | Operator | Checked by |
|---|---|---|---|---|---|---|
| Sifting | ||||||
| Blending | ||||||
| Granulation / drying | ||||||
| Lubrication | ||||||
| Compression | ||||||
| Coating |
In-process controls
Blend uniformity RSD not more than 5.0 percent. Tablet weight 650 mg +/- 5 percent. Hardness 8 to 14 kP. Friability not more than 1.0 percent. Disintegration not more than 15 minutes.
In-process results
| Test | Limit | Result | Time | Tested by | Pass / Fail |
|---|---|---|---|---|---|
| Blend uniformity | |||||
| Average weight | |||||
| Hardness | |||||
| Friability | |||||
| Disintegration |
Yield reconciliation
| Stage | Theoretical | Actual | Yield % | Limit % |
|---|---|---|---|---|
| After granulation | 98 to 102 | |||
| After compression | 97 to 100 | |||
| After coating | 97 to 100 |
Deviations and comments
Record any deviation, with deviation number, here. Write no data in pencil, do not overwrite, and correct with a single line, date and initials.
Review and release
A starting layout, not a controlled document. In a GMP plant the executed batch record must be issued from an approved master batch record under document control, with unique batch pages and reconciliation of issued and returned records. Adapt limits to your validated process.
Get a batch record review checklist matched to your ERP
An optional walkthrough of how ERP batch genealogy and executed batch records can be cross-checked before QA release.
Optional. The tool and every export work without this. No spam.
How to use the template
Fill the header fields with product, batch number, batch size and master record reference, paste your process steps and in-process limits, then export to PDF or Word. The table blocks stay blank on purpose, because operators record observed values by hand or in the MES at the time of the activity. Use it to prototype a layout, to train new batch record reviewers, or as a skeleton when you convert a paper record to an electronic batch record.
- Header ties the record to the master batch record version
- Line clearance comes before any material is issued
- Dispensing shows theoretical and actual quantity with a second check
- Yield reconciliation is recorded stage by stage
What regulators expect in a batch record
FDA 21 CFR 211.188 requires a batch production and control record that documents each significant step, including dates, equipment identification, component lot numbers, weights and measures, in-process and laboratory results, yield at appropriate phases, and the signatures of the operator and the person who checked each step. EU GMP Chapter 4 and Annex 15 expect the same traceability. The record must be contemporaneous, attributable, legible and complete, which is why no step should be pre-filled.
Reading the yield reconciliation
Yield is actual quantity divided by theoretical quantity at each stage. Limits are product specific and come from process validation; the figures shown are only examples. A yield outside the range is not just a number to note. It is a trigger to start a deviation, because a loss or gain can mean mix-up, spillage, a weighing error or cross-contamination. Reconcile labels and printed packaging separately at packing.
Common mistakes and ERP notes
The most frequent audit findings are blank fields without NA, overwritten entries, unsigned checks, missing equipment IDs and batch pages not reconciled. In SAP, Oracle, Epicor or SyteLine the process order or job carries quantities and component lots, but the BMR narrative and in-process results usually live in a separate system. Make sure the lot numbers in the paper or electronic record match the ERP batch genealogy before release.
- Do not use correction fluid or pencil
- Record actual values, never ticks, for critical parameters
- Cross-reference deviation numbers in the record
Frequently Asked Questions
What is the difference between a master and an executed batch record?
The master batch record is the approved, version-controlled instruction for a product and batch size. An executed batch record is a uniquely numbered copy issued for one batch, completed during manufacture and reviewed by QA before release.
Who must sign a batch manufacturing record?
The operator who performs a step, a second person who verifies critical steps such as weighing, the production supervisor who reviews the whole record, and a QA reviewer who approves it before disposition. Signatures need a date and, ideally, time.
Can I use this template as my controlled BMR?
Not as is. It is a layout to adapt. A controlled BMR needs a document number, version, approvals, validated limits and issuance control under your quality system. Use it to draft, then route through change control.
How long must batch records be kept?
Under 21 CFR 211.180 records are kept at least one year after the batch expiry date. EU rules generally require retention for at least one year after expiry or five years after certification, whichever is longer. Check local rules.
If your batch genealogy sits in the ERP and the record sits elsewhere, Netray can help build a private review assistant that compares both before QA release. This page works fully without it.
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