Batch Records, eBMR and Manufacturing Documentation — From MBR/MMR to Release and Inspection

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

Updated November 2025 • batch records, BMR, MBR, MMR, eBMR, DMR, DHR, eDHR, QMSR, data integrity, Part 11 / Annex 11, GAMP 5, batch review by exception, release • Pharma, Biologics, ATMPs, Medical Devices, Combination Products, Dietary Supplements, High-Risk Food & Cosmetics

Batch records are the primary evidence that a specific batch of product was made, tested, packaged and released in line with its registered, validated process. The terminology differs by industry—Batch Manufacturing Records (BMR), Master Batch Records (MBR), Master Manufacturing Records (MMR), Electronic Batch Records (eBMR), Device Master Records (DMR), Device History Records (DHR), eDHR—but the pattern is the same:

One set of master instructions. Many batch-level executions. A web of supporting documentation. And an inspector asking, “Show me the evidence.”

“If you cannot reconstruct how a batch was made from its documentation alone—who, what, when, with which materials, equipment and decisions—you don’t have batch records. You have paperwork.”

1) Master vs batch — MMR/MBR vs BMR

Regulators distinguish clearly between “what should happen” and “what did happen”:

• Master Manufacturing Record (MMR) / Master Batch Record (MBR). The master defines how to make the product: components, quantities, equipment, order-of-addition, CPPs, IPCs, in-process hold times, cleaning, sampling, lab tests, packaging and labelling. See: MMR and MBR.
• Batch Manufacturing Record (BMR). The BMR is a batch-specific instantiation of the MMR/MBR—the record of one execution: operators, dates, lots, weights, process values, deviations and results. See: BMR.

Same pattern for devices:

• Device Master Record (DMR). The “recipe” and SOP set for manufacturing a device or device family. See: DMR.
• Device History Record (DHR). The unit- / batch-level record showing that each device was built and tested according to the DMR. See: DHR.

In a compliant environment, you cannot fix a broken MMR/MBR/DMR by “being careful” at batch level. The master must be correct and under Change Control. The batch record proves adherence—or documents divergence—for that master.

2) What a good BMR or DHR actually contains

Across pharma, devices, biologics and supplements, the structure of a batch record is surprisingly consistent. A good BMR/DHR shows:

• Identification. Product, strength, dosage form, batch/lot number, size, route, relevant MMR/MBR/DMR version.
• Components & lots. Required components, actual lot numbers, quantities weighed/dispensed, reconciliation of usage vs plan. Linked to component lot traceability.
• Equipment & facilities. Equipment IDs, status (calibration, IQ/OQ/PQ), cleaning and line clearance.
• Stepwise execution. Documented execution of each step from the master—charge, mix, granulate, filter, sterilise, fill, assemble, label—with operator initials/signatures and timestamps.
• Process data & CPPs. Recorded CPPs, alarms, setpoints and adjustments.
• In-Process Controls (IPC). Instructions, sample IDs, results and decisions for IPC, IPV and PAT checks.
• Yield & reconciliation. Comparison of theoretical vs actual yields, scrap, rework, reconciliation of printed components and labels.
• Deviations & CAPA. Links to deviations/NCs, CAPA and risk assessments.
• QC data & release. Analytical results, CoAs, OOS/OOT investigations, final QA/QP decision and release status.

In other words, a BMR/DHR is not “paper for QA”. It is the structured story of the batch, written as you go—or, in modern systems, generated as a by-product of controlled execution.

3) Paper vs hybrid vs Electronic Batch Records (eBMR / eDHR)

Manufacturers typically sit somewhere along this spectrum:

• Paper-driven BMR. Pre-printed, pre-approved forms completed by hand. Pros: low perceived tech risk, inspectors know the format. Cons: illegible entries, missing steps, manual calculations, transcription errors, painful queries.
• Hybrid. Some electronic data (e.g., LIMS, SCADA printouts) stapled into paper BMRs. Often worse than pure paper because the evidence is scattered and data integrity is harder to prove.
• eBMR / eDHR. Instructions, data capture, checks and signatures implemented in an MES-style system—with full Part 11 / Annex 11 controls. Pros: enforced workflows, fewer errors, much faster review, easier analytics.

The transition isn’t only about digitising a form; it’s about making the system an active participant in execution. That’s the core difference between “electronic documents” and a true eBMR/eDHR platform like V5 MES.

4) Data integrity, Part 11, Annex 11 and GAMP 5

Batch records—paper or electronic—are prime targets in data integrity inspections. Regulators expect ALCOA+ attributes (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available), plus specific controls for electronic records:

• Part 11 / Annex 11. 21 CFR Part 11 and EU Annex 11 require secure user accounts, role-based access, e-signatures with meaning, audit trails and validated systems.
• GAMP 5. GAMP 5 provides a risk-based approach to computer system validation (CSV) for eBMR/eDHR platforms.
• Audit trails. GxP audit trails record who changed what, when and why—for instructions, limits, results and signatures.
• Record retention & archival. Record retention and archival policies ensure batches remain accessible and readable for the full regulatory period.

In an eBMR context, these controls are not bolt-ons; they are core design requirements for how the system is configured and validated.

5) Batch Review, Batch Review by Exception (BRbE) and release

Once execution is complete, the batch enters the review cycle. Two patterns dominate:

• Traditional full review. QA manually checks every page or screen, line by line, for completeness, correctness and legibility.
• Batch Review by Exception (BRbE). The system applies rules to flag exceptions—missing data, out-of-tolerance values, late steps, unexpected edits—so QA focuses on non-standard events. See: Batch Review by Exception (BRbE).

Release decisions are documented in the batch record and supporting systems:

• Release status. Products move from quarantine to released or rejected via QA decisions recorded under release status.
• Batch release. Manufacturing only ships and WMS only picks from released lots, as defined in batch release and finished goods release procedures.
• QP release (EU / UK). For EU/UK licenced medicinal products, a Qualified Person (QP) certifies each batch, relying heavily on eBMR/DHR data.

BRbE is one of the biggest ROI levers of eBMR: fewer manual checks, faster release, more focus on risk. But it only works if execution data is structured and reliable—exactly what V5 aims to enforce.

6) Batch records in lifecycle quality — APR/PQR, CPV and inspections

Batch records are not just for release; they also feed lifecycle quality activities:

• Annual Product Review / Product Quality Review. APR / PQR require analysis of batches released in the period: yields, deviations, OOS/OOT, complaints, changes and trends.
• Continued Process Verification (CPV). CPV looks at CPPs, CQAs and performance metrics across batches to show a process remains in a state of control.
• Inspections & audits. Inspectors routinely pick a batch (or three) and use the record as an entry point to explore data integrity, systems and the effectiveness of your QMS.

If your batch records live in boxes or semi-structured PDFs, APR/PQR/CPV become manual data-mining projects. With a well-implemented eBMR (V5-style), they become queries and dashboards.

7) How V5 delivers eBMR/eDHR and manufacturing documentation

V5 Traceability is designed to turn your MMR/MBR/DMR into controlled execution and clean eBMR/eDHR records:

• Master implementation. MMR/MBR/DMR content is configured into V5 MES workflows—steps, parameters, equipment assignments, sampling plans, tolerances and interlocks—under formal change control.
• Execution capture. Operators follow step-by-step instructions; machines and instruments send readings; V5 records everything in a structured, attributable way—with audit trails, user IDs and timestamps.
• Automatic genealogy links. V5 ties batches to material lots, equipment and test results, building the lot- and batch-level genealogy as execution proceeds.
• Review by exception. Configuration supports BRbE; QA sees exceptions rather than having to re-check every normal step, shrinking the release cycle.
• Integration with WMS/LIMS/QMS. eBMR/eDHR data connects with V5 WMS (inventory, shipments), LIMS (test results) and QMS (deviations, CAPA), so batch records represent the whole story, not just MES data.

The goal is simple: move from fragile paper and hybrid records to robust, inspectable, analytics-ready eBMR/eDHR—without losing the nuance regulators care about.

FAQ — Batch Records, eBMR and Manufacturing Documentation

Q1. What is the difference between MMR/MBR and BMR?
The MMR / MBR defines how a product should be made—components, steps, equipment, tests and limits. The BMR is the batch-specific record that shows how one batch was made in practice, including any deviations.

Q2. Is an Electronic Batch Record (eBMR) mandatory?
Not universally. Many regulators still accept paper records if they meet GMP and data integrity expectations. However, eBMR is increasingly common because it reduces errors, speeds up release, supports review by exception and makes APR/PQR/CPV feasible without manual data mining.

Q3. How does eBMR relate to Part 11 and Annex 11?
eBMR systems are in scope for Part 11 and Annex 11. They must implement secure user accounts, e-signatures with defined meaning, audit trails, validated configurations and controlled access, all under a risk-based CSV approach consistent with GAMP 5.

Q4. What is Batch Review by Exception (BRbE)?
Batch Review by Exception is a QA review strategy where the eBMR system flags exceptions (out-of-limits, edits, missing steps, late actions) so QA can focus on what went wrong or unusual, instead of re-checking every routine entry.

Q5. How do batch records support APR/PQR and CPV?
Batch records provide the raw data for Annual Product Reviews / Product Quality Reviews and Continued Process Verification: yields, deviations, CAPA, test results, complaints and CPP trends. With eBMR, these can be aggregated automatically; with paper, they often require manual extraction.

Q6. Can small and mid-sized manufacturers implement eBMR without a monolithic ERP?
Yes. Many use light ERP or QuickBooks for finance and orders, and implement eBMR in a system like V5 MES that focuses on execution, data capture and traceability. Summarised movements and cost impacts are then fed back into the ERP layer.

Q7. Where should we start if we’re on paper today?
Pick one high-impact product or line. Stabilise the MMR/MBR; map current paper entries to structured data fields; configure an eBMR workflow in MES; validate a pilot; and run through a couple of full batches and QA reviews. Once that pattern works, expand to more products and lines.

Related Reading (Glossary)
• Master & Batch Records: MMR | MBR | BMR | eBMR
• Device Documentation: DMR | DHR | eDHR | QMSR
• Data Integrity & Systems: 21 CFR Part 11 | Annex 11 | GAMP 5 | Audit Trail | Data Integrity
• V5 Platform: V5 Solution Overview | V5 MES | V5 QMS | V5 WMS | V5 Connect API