Master Batch Record (MBR) – Controlled Recipe & Execution Blueprint

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated October 2025 • cGMP, eBMR/MES Integration, Data Integrity & Traceability • QA/RA, Manufacturing, Technical Ops

The Master Batch Record (MBR) is the authoritative, pre‑approved blueprint that defines how a batch must be made—materials, equipment, steps, parameters, in‑process controls, sampling, labels, and acceptance criteria. It is the single source of truth for execution and release. In FDA drug GMPs (21 CFR Part 211), ISO 13485 device manufacturing, and ISO 22716 cosmetics GMP, the MBR (sometimes called the MMR for certain regulated sectors) sits under formal Document Control and change authority. During production, the MBR drives the real‑time eBMR in the MES, generating a legally defensible Batch Manufacturing Record (BMR)—the “as‑run” evidence—complete with audit trails, electronic signatures (21 CFR Part 11/Annex 11), and attachment links to LIMS, COAs, and equipment status. Practically: a good MBR eliminates ambiguity and prevents “tribal variants.” A weak one invites deviation, rework, and recalls.

“If it’s not in the Master, it’s not in the batch. If it’s not executed as written, it’s not releasable.”

1) What the MBR Covers—and What It Does Not

Covers: full manufacturing intent for a batch—BOM, materials and grades, source controls (supplier qualification), weigh/dispense rules (Weighing & Dispensing), equipment/trains, sequence of operations, parameter sets with safe/validated limits, IPC sampling plans (GMP sampling), QC tests, label/UDI checks, yield calculations, acceptance criteria, and disposition rules. It also embeds preconditions (line clearance, cleaning status), line clearance and cross‑contamination controls, and packing/ship instructions tied to WMS.

Does not cover: redefining validated design space or bypassing quality governance. The MBR can only specify within the proven ranges from Process Validation/PPQ. Changes to chemistry, technology, equipment, or specs go through MOC/Change Control before the MBR is revised and re‑released.

2) Legal, System, and Data Integrity Anchors

Regulators expect controlled masters and complete “as‑run” evidence. That means Part 211 (drugs), QMSR/ISO 13485 (devices), and ISO 22716 (cosmetics), backed by Part 11/Annex 11 requirements for electronic records. The MBR lives under controlled distribution with version/effective dates; the eBMR captures execution with unique users, time stamps, and audit trails. Systems must be validated (CSV), and records retained per Retention & Archival. Data integrity principles (ALCOA+) apply to both master content and batch evidence.

3) The MBR Evidence Pack

A complete dossier shows: controlled MBR with headers (IDs, revision, effective date), formulas and BOMs, component qualification (Component Release, COAs), calibrated equipment lists (IQ/OQ/PQ, status), sequenced steps with parameter ranges, IPC plans with sample sizes (AQL where used), test methods and TMV, label/serialization content (GS1 GTIN, UDI, Part 830), yield and reconciliation logic, deviation/OOS handling (OOS/OOT), and final release status criteria. Attach or reference validation reports (PPQ, cleaning), and risk files (QRM).

4) From Development to Approved Master—A Standard Path

1) Define the Product & Process. Development fixes the target formula, critical material attributes, and unit operations. Create draft masters in a recipe tool (Master Recipe Management) and define units/UOM (UOM consistency).

2) Validate. Execute Process Validation—including PPQ—and confirm cleaning (Cleaning Validation). Establish sampling/testing in LIMS; verify methods.

3) Author the MBR. Build step‑wise instructions with parameter ranges and IPC gates. Include line clearance, segregation, and label checks. Map required attachments (COAs, SDS, equipment logs).

4) Govern & Train. Route via Approval Workflow under Document Control; trigger role‑based training (Training Matrix).

5) Execute as eBMR. Deploy into MES for eBMR. Enforce preconditions (device status, materials released, line cleared) and capture data at source with audit trails.

6) Monitor & Improve. Feed results to CPV/PQR/APR. Improve masters via controlled MOC/Change Control.

Nothing starts if prerequisites fail—uncalibrated device, unreleased component, expired cleaning, or outdated training. The MBR should block execution until the gap is closed.

5) Authoring the MBR—A Practical Method

Structure the master for clarity and control: (i) Header with IDs, revision, effective date, product strength/size, markets, and governing standards; (ii) BOM with spec codes, grades, and Goods Receipt/Component Release rules; (iii) Equipment lists with required status and qualification; (iv) Steps with clear verbs, parameter targets and ranges, alarms/interlocks, and dual verification for critical actions; (v) IPC & QC with sampling, tests, and acceptance criteria tied to LIMS; (vi) Labeling & Pack with verification steps and serialization when applicable; (vii) Yield & Reconciliation with mass balance checks; (viii) Deviation/OOS handling and release disposition.

Use digital building blocks: controlled recipe versioning, parameter libraries, and standardized step templates (ISA‑88 phases/modules) so changes are consistent, reviewable, and testable before deployment.

6) Critical Parameters, IPC & Sampling

Integrate control strategy into the MBR: identify CPPs and key performance parameters; set ranges from validation; define IPC tests, limits, and actions. Link statistical control where appropriate—SPC with documented control limits (e.g., X‑bar/R) and escalation when UCL/LCL breaches occur. Define sample sizes and frequencies using GMP sampling plans; route lab work via LIMS. For identity, potency, and impurities, anchor to validated methods (TMV) and instruments (e.g., HPLC, UV‑Vis).

7) Data Integrity—Proving Intent vs. Execution

The MBR defines the intent; the BMR/eBMR proves what actually happened. Eliminate transcriptions: capture raw data at the source (balances, weighing, temperature/pressure from PLC/SCADA, sample scans) with attributable audit trails. Bind steps to identity and time using electronic signatures (Part 11) and restrict free‑text entries. Control attachments (COAs, chromatograms), keep links stable under retention, and make every calculation reproducible. If the eBMR can’t reconstruct yields, holds, and exceptions, you don’t have a compliant record.

8) Labels, Serialization & End‑to‑End Traceability

Labels must reflect execution. Pull variable data (lot/exp, strength, net content) from the eBMR; verify barcodes with Label Verification. For regulated products, manage identifiers (GTIN, UDI, SSCC) and publish events using EPCIS. Maintain lot genealogy from supplier to batch to case/pallet (batch‑to‑bin). Keep inventory under Quarantine/Hold until QA disposition, then release to the WMS for Pack & Ship using FEFO/FIFO.

9) Equipment, Calibration & Qualification

The MBR must call up specific equipment classes, minimum capabilities, and status checks. Enforce qualification (IQ/OQ/PQ), utilities readiness (UQ), and instrument calibration via Calibration Status. Define warm‑up times, minimum weight for balances, and temperature mapping for storage/processing (Temperature Mapping). GxP execution demands that a piece of kit “in red” blocks the step until remediated—no exceptions.

10) Materials, Weighing & Dispensing

Precision starts at weigh. Govern component intake via Goods Receipt and Component Release. Execute dispensing with gravimetric controls, macro dosing for bulk and micro‑ingredient dosing for actives or critical additives, handling tare correctly and enforcing ID matches. Add allergen and segregation logic for food/cosmetics (Allergen Control, Cross‑Contamination). Bad weighs create bad batches—lock it down at source.

11) Yield Accounting & Reconciliation

The MBR must define theoretical yields and allowable loss per step. Capture gains/losses as you go and reconcile at end (Mass Balance). Tie scrap/rework rules to controlled reprocessing; account for backflush where used (Backflush Accounting). Persistent yield loss is a signal for RCA and COPQ reduction.

12) Deviations, OOS/OOT & Continuous Verification

Define how operators respond to abnormal events. Route execution breaks to Deviation, lab failures to OOS, and trend excursions to OOT. Investigate with RCA; implement CAPA. Feed findings into CPV and the next MBR revision through MOC/Change Control. Paper tolerance for repeated failure is zero.

13) Metrics That Demonstrate Control

• Right‑First‑Time (RFT) rate by product and line.
• MBR Revision Cycle Time and percent changes completed under MOC on schedule.
• Exception Density (deviations per 1,000 steps) and Repeat Cause Rate.
• Yield Variance vs. theoretical at critical steps; mass balance closure.
• Training Currency for roles tied to the current MBR version.
• Release Lead Time (last step to QA release), with eBMR completeness score.

These KPIs link master quality to execution performance and release velocity. If they’re off, your master isn’t masterful.

14) Common Pitfalls & How to Avoid Them

• Ambiguous steps. Use clear verbs, parameters, and acceptance criteria; ban “as appropriate.”
• Shadow spreadsheets. Put calculations into the eBMR with controlled logic and audit trails.
• Uncontrolled attachments. Govern COAs and methods under Document Control/LIMS; keep links stable.
• Equipment not in status. Enforce status interlocks to block steps.
• Out‑of‑date training. Trigger retraining on each release; block sign‑offs for expired roles.
• Change without validation. Route via MOC/Change Control; re‑validate if ranges or kits change materially.

15) What Belongs in the MBR Dossier

Include the controlled master (with header metadata), BOM and specs, equipment lists with qualification, sequenced steps with ranges and alarms, IPC/QC plan and methods (TMV), label/serialization logic, yield/reconciliation logic, deviation/OOS handling, and release criteria. Reference validation (PV/PPQ/cleaning), risk files (QRM), and training packages. Govern everything under Document Control with retention rules aligned to market requirements.

16) How This Fits with V5 by SG Systems Global

MBR as Master Data. In the V5 platform, the MBR is a governed object with versioning, effective dating, and linked recipes (Master Recipes). Changes route via Approval Workflow and leave a full audit trail.

Execution & Interlocks. The V5 MES pushes the master to the shop floor as a guided eBMR. It checks calibration status, component release, and line clearance before each critical step. If a prerequisite fails, execution blocks and launches a remediation workflow.

Integrated Evidence. V5 captures raw values from balances and controllers (gravimetric, temperature, pressure), stores method results via LIMS links, and outputs a complete eBMR with signatures for QA review and release disposition.

Downstream Alignment. V5’s labeling reads the executed data to avoid mismatch; WMS integration keeps lots in Quarantine/Hold until release, then supports compliant Pack & Ship with EPCIS eventing.

Bottom line: V5 operationalizes the MBR—authoring, approvals, interlocks, data capture, labs, labeling, and release all synchronize so batches run right the first time and pass QA without drama.

17) FAQ

Q1. What’s the difference between MBR, BMR, and eBMR?
The MBR is the controlled master (intent). The BMR is the “as‑run” batch record (evidence) generated during execution. An eBMR is the electronic BMR inside the MES with Part 11/Annex 11 controls, replacing paper and eliminating transcription risk.

Q2. How often should MBRs be reviewed?
At minimum on a defined cycle (e.g., annually) and whenever significant changes occur—new suppliers, equipment, ranges, specs, stability data—or when PQR/APR/CPV trends trigger improvements.

Q3. Can the MBR include ranges instead of single setpoints?
Yes—within validated design space. The MBR should state targets and acceptable ranges with actions if limits are approached or crossed.

Q4. How are changes to an MBR controlled?
Through MOC/Change Control with impact assessments (validation, labeling, training), formal approvals, version updates, and training retriggers before release.

Q5. How does the MBR interact with validation?
Validation establishes the proven ranges and controls; the MBR encodes them for routine use. If the MBR needs to move beyond validated limits, re‑validation is required.

Q6. What attachments belong with the MBR?
Current COAs, lab methods/specs, cleaning procedures, equipment logs, label artwork/verification rules, and any risk assessments or validation summaries referenced in the steps—all governed under Document Control.

Related Reading
• Records & Control: BMR | eBMR | MMR | Document Control | Audit Trail | Retention
• Execution & Validation: MES | Process Validation | PPQ | CPV | IQ/OQ/PQ
• Materials & Labs: Weigh & Dispense | Gravimetric Weighing | LIMS | TMV | COA
• Labels & Traceability: Label Verification | GS1 GTIN | UDI | SSCC | EPCIS | Lot Genealogy
• Quality System: 21 CFR Part 211 | Part 11 | ISO 13485 | ISO 22716 | Quality Control | QA