Every batch manufactured in the pharmaceutical industry requires complete, traceable, and reviewable documentation. This is achieved through a set of batch records that guide the process, document the execution, and verify that critical steps were followed as approved. These documents go far beyond the commonly referenced “Batch Manufacturing Record.”
They include master records that define the process. These execution records capture real-time data, packaging and labelling records, and supporting logs that document equipment, cleaning, in-process control, and analytical activities. Together, they provide the technical and regulatory foundation for releasing a batch to the market.
In this article, we break down the main types of batch records used in the pharmaceutical industry, their purposes, regulatory basis, and their place in the overall manufacturing lifecycle.
What Are Batch Records?
А batch record is the full, time-aligned documentation for a specific batch of finished product or API. It brings together everything that happened to that batch: manufacturing steps, packaging operations, equipment cleaning status, in-process controls, and quality control results, including who performed each step and when.
The aim is simple: anyone reviewing the record should be able to reconstruct the batch’s history without guessing or filling in gaps.
Core Elements
Whether on paper or in an EBR system, a batch record typically includes at least:
- Identification of the product and batch (name, strength, dosage form, batch/lot number).
- Materials and components used, with internal codes, quantities, and lot numbers.
- Executed manufacturing and packaging steps, with dates, times, and operator/checker identification.
- In-process control results and any deviations, alarms, or non-routine interventions.
- Equipment identification and status/cleaning information relevant to the batch.
- Analytical and microbiological results that support batch release.
- Final review and approval entries from production and QA (and QP where applicable).
| Area | What Must Be Documented |
|---|---|
| Product Identification | Product name, strength, dosage form, batch/lot number |
| Materials | Component IDs, quantities, supplier and lot numbers |
| Manufacturing & Packaging | Steps performed, dates and times, operator and checker identification |
| In-Process Controls | IPC results, alarms, deviations, and interventions |
| Equipment | Equipment ID, cleaning status, and suitability for use |
| QC & Micro Results | Analytical and microbiological results supporting batch release |
| Approvals | Production review, QA approval, and QP certification where applicable |
Purpose of Batch Records
Batch records support four main areas:
- Traceability – clear linkage from raw materials and intermediates through to finished product and distribution decisions.
- Demonstration of control – evidence that the approved and validated process was followed.
- Data integrity and accountability – every action and decision is attributable, legible, and recorded at the time it occurred.
- Regulatory review – core evidence set used by inspectors and by the QP or QA to decide whether a batch can be released.
Types of Batch Records
The documentation package for each batch is built from several record types, each serving a distinct purpose within the manufacturing lifecycle. Understanding how these GMP documents relate to one another is essential for maintaining process control, ensuring traceability, and supporting batch certification.
Master Batch Record (MBR)
The Master Batch Record defines the approved manufacturing process for a product. It serves as the authoritative instruction set that operators must follow and represents the process as validated and filed with regulatory authorities.
Unlike day-to-day paperwork, the MBR is a controlled, version-managed document. Any modification to it must undergo formal change control because a change to the MBR is a change to the process itself.
Professionally, the MBR functions as:
- The blueprint for how the product must be manufactured
- The reference point for batch review and deviation assessment
- The standard against which process consistency is measured
An effective MBR removes operator interpretation by providing clear, complete, and approved instructions. Its quality directly affects the Batch Production Record that follows.
Batch Manufacturing Record (BMR)
If the MBR is the blueprint, the BMR is the evidence of execution. It documents the batch’s manufacturing steps in detail and captures real-time operational data.
The BMR shows:
- what was done,
- when it was done,
- by whom,
- using which equipment and materials,
- and whether the results remained within approved limits.
It is the primary document used by QA during batch review because it reveals:
- process adherence,
- the presence or absence of atypical events,
- the accuracy and completeness of recorded data, and
- whether the batch can be released.
A well-maintained BMR provides a transparent manufacturing history that aligns with the MBR instructions. A poorly maintained BMR indicates data integrity risks and is a common focus area during inspections.
Batch Packaging Record (BPaR)
After manufacturing, the focus shifts to packaging, a GMP-critical stage due to the risk of mislabeling, component mix-ups, and product substitution. The Batch Packaging Record documents all activities conducted during packaging and labelling and provides full traceability of printed components.
The BPaR demonstrates:
- that the correct packaging materials were used,
- that the artwork and variable data (batch number, expiry date) were verified,
- that line clearance was performed to remove remnants of the previous batch, and
- that in-process checks were performed at the required intervals.
Because packaging errors directly affect patient safety, regulators carefully examine BPaRs. Clear reconciliation, verified labelling, and consistent entries are essential elements of a compliant batch record.
Cleaning and Equipment Use Records
While not batch records by name, cleaning logs and equipment-use records are batch-relevant documents. QA must review them to confirm that production equipment was clean, suitable, and in the correct state before the batch began.
These records demonstrate:
- the cleaning status of each piece of equipment,
- its sequence of use across products and batches,
- whether cleaning was performed according to the validated procedure, and
- that no cross-contamination risks were present.
In GMP investigations, these logs are frequently referenced to determine whether equipment condition contributed to a deviation or atypical result. Their role is supportive but essential: they document the batch’s manufacturing history.
Analytical and Quality Control Records
Manufacturing records alone cannot justify batch release. Analytical and QC records provide the scientific confirmation that the batch meets all quality specifications.
These records include:
- results of raw material and in-process testing,
- finished product results,
- method and equipment used,
- review and approval signatures, and
- any investigations associated with OOS, OOT, or atypical data.
From a regulatory standpoint, QC documentation must clearly demonstrate data integrity and traceability. These records become part of the total batch package reviewed before release and are stored in alignment with data retention requirements.
Electronic Batch Records (EBR)
Modern facilities increasingly use Electronic Batch Records as a digital alternative to paper-based documentation. Although the captured data is identical, the execution and control methods differ significantly.
EBRs:
- automate data capture from equipment and sensors,
- enforce process steps and prevent unauthorized changes,
- incorporate audit trails and electronic signatures,
- reduce transcription errors,
- and support review-by-exception approaches.
Transitioning from paper to EBRs does not change the regulatory requirements; only the format changes. The same principles of traceability, accuracy, contemporaneous entry, and completeness continue to apply.
How to Create and Manage Batch Records
Creating and managing batch records requires a controlled, consistent approach that aligns process knowledge, regulatory requirements, and day-to-day operational practices. The goal is not only to document the batch but to ensure that the documentation itself supports process control, traceability, and reliable decision-making.
Develop Clear, Controlled Master Records
The starting point is the Master Batch Record (MBR), which defines the approved, validated manufacturing process.
A compliant MBR should be:
- Based on validation studies, process characterization, and regulatory filings
- Written in clear, operational language that eliminates subjective interpretation
- Version-controlled under the quality documentation system
- Linked to equipment lists, material specifications, analytical methods, and SOPs
- Reviewed and approved by QA, Production, and relevant technical functions
The quality of the MBR determines the clarity and consistency of all subsequent batch records.
Train Operators and Supervisors on Documentation Practices
Proper completion of batch records depends heavily on consistent operator training.
Training should include:
- How to record data contemporaneously
- How to perform corrections without obscuring the original entry
- How to record time, ID, signatures, and check steps
- How to escalate deviations or unexpected events
- How to use electronic systems if EBRs are implemented
This ensures that the record reflects what actually happened, not what operators remember later.
Execute Batch Records in Real Time
Execution requires disciplined recording of each activity as it occurs.
Key expectations:
- Entries must match the sequence defined in the MBR
- Data should be entered as soon as the step is completed, not later in the shift
- Equipment IDs, material lots, and actual parameters must be accurate
- Any automation printouts (balance tickets, sensor outputs) must be attached or electronically linked
- Any deviation from the instruction must be immediately documented and assessed
Real-time documentation is a core pillar of data integrity.
Manage Deviations, Holds, and Atypical Events Properly
No batch runs perfectly. What matters is how non-routine events are documented.
GMP-aligned handling includes:
- Describing the event in the batch record when it happens
- Opening a deviation or non-conformance for further investigation
- Recording immediate actions (hold, pause, checks performed)
- Documenting QA approval when continuation is allowed
- Linking the investigation outcome to the batch record
This ensures transparency and supports accurate batch release decisions.
SEE ALSO: Deviation Management Process in GMP
Perform Structured, Independent Batch Record Review
After execution, batch records undergo a systematic review.
A robust review includes:
- Verification that all steps were completed and signed
- Check of material traceability, yields, and reconciliations
- Review of IPC results and equipment status
- Confirmation that deviations and investigations are closed
- Assessment of data integrity (consistency, legibility, corrections)
Review should be independent, typically by production first, then QA.
Approve and Certify the Batch
Once the documentation is complete, QA (and the QP in the EU system) makes the release or certification decision.
The decision is based on:
- Completeness and accuracy of the batch records
- Compliance with MBR instructions
- Acceptable analytical results
- Closure and evaluation of all deviations
- Compliance with regulatory and MA/CMC requirements
Documentation must fully support that the batch remained under control.
Maintain, Archive, and Retrieve Records Securely
Retention and archival requirements vary by region, but the principles remain the same: records must be secure, accessible, and protected throughout the retention period.
Good practices include:
- Controlled storage for both paper and electronic records
- Defined retention times (expiry + 1 year minimum in EU)
- Secure access with traceability of retrieval
- Regular backup and disaster-recovery measures for EBR systems
- Procedures for providing records during inspections
Proper archival ensures that documentation remains available for future audits, investigations, or regulatory requests.
Integrate Electronic Systems for Efficiency and Data Integrity
When migrating to Electronic Batch Records (EBRs), companies must ensure the system is validated and aligned with Annex 11/Part 11 requirements.
Key advantages of EBRs:
- Automated enforcement of process parameters
- Integrated audit trails and electronic signatures
- Fewer manual errors and transcriptions
- Real-time deviation capture
- Faster batch review (review-by-exception)
Digital systems strengthen data reliability and streamline batch disposition.
Lifecycle of Batch Records
Batch records follow a defined lifecycle that begins long before a batch is manufactured and continues well after the product is released. Each phase serves a specific function in demonstrating that the process is controlled, the documentation is reliable, and the batch remains fully traceable.
1. Design and Creation of Master Records
The lifecycle begins with the development of the Master Batch Record (MBR), which represents the approved, validated process. This stage includes:
- Translating process development and validation data into a clear operational document
- Аligning instructions with equipment capability, material specifications, and control strategies
- Linking the MBR to analytical methods, packaging records, and relevant SOPs
- Formal approval under change control
This establishes a controlled template from which all executed batch records will be generated.
2. Issuance of Executable Records
Before manufacturing begins, the approved MBR is issued as an executable Batch Manufacturing Record (BMR) and, when applicable, a Batch Packaging Record (BPaR).
Key expectations:
- Issuance through a controlled document management system
- Confirmation that the current version is used
- Assignment of batch number and manufacturing date
- Distribution to authorized production personnel
In electronic systems, “issuance” includes generating a controlled template instance in the EBR system.
3. Execution and Real-Time Data Entry
This phase covers the actual manufacturing, packaging, and testing of the batch.
Activities include:
- Recording operations as they occur
- Documenting materials, parameters, equipment, and in-process results
- Capturing deviations, alarms, or non-routine events
- Attaching or linking supporting data (e.g., balance printouts, instrument outputs)
This forms the factual, chronological history of the batch. Regulators place the strongest emphasis on this phase, as it contains the primary evidence of GMP compliance.
4. Review and Reconciliation
After execution, production, and QA review, the complete set of batch documentation.
This stage ensures:
- All steps were completed and appropriately signed
- Data is consistent, legible, and accurate
- Material and label reconciliations match the MBR expectations
- All deviations, OOS/OOT events, or equipment issues are addressed
- Calculations are correct, and supporting logs are available
For electronic records, this includes, where applicable, audit trail review.
5. Batch Release or Certification
Once QA determines that the batch documentation is complete and compliant, the batch moves to formal disposition. In the EU system, this is the point where the Qualified Person (QP) certifies the batch for release.
Release decisions are based on:
- Compliance with the MBR
- Acceptable QC results
- Closure of all deviations and investigations
- Alignment with MA/CMC expectations
- Completeness of documentation
No batch may be released without complete and verified batch records.
6. Archival and Retention
After release, batch records enter the archival phase, where they must remain secure, legible, and retrievable for the whole retention period.
Requirements include:
- Controlled storage (paper or electronic)
- Protection against loss, alteration, and unauthorized access
- Defined retention time (expiry + 1 year in EU; expiration + 3 years in US; 3 years minimum for APIs)
- Traceable retrieval procedures for audits, PQRs, or investigations
- Validated backups and disaster recovery for EBRs
This phase ensures that the batch record remains available for regulatory inspections or future analysis.
7. Continuous Improvement and Updates
The batch record lifecycle does not end with archival. Information obtained from executed records drives improvements to the master documents.
Triggers for updating the MBR include:
- Repeated deviations
- Trends observed in PQR or CPV
- Changes to equipment or materials
- Updates to regulatory filings
- Improvements arising from inspections
Changes follow formal change control to ensure continuity and traceability across versions.
The Role of Electronic Batch Records (EBRs)
The pharmaceutical industry is steadily moving from paper-based batch documentation to fully digital systems. Electronic Batch Records (EBRs) integrated with Manufacturing Execution Systems (MES) are transforming how processes are executed, documented, and reviewed. While the regulatory principles remain unchanged, the way we achieve compliance is evolving rapidly.
EBRs introduce a level of control, traceability, and data connectivity that goes far beyond traditional documentation. They enforce compliance in real time, reduce the risk of human error, and enable more streamlined review processes.
| Dimension | Paper Records | Electronic Batch Records (EBR) |
|---|---|---|
| Compliance Control | Dependent on discipline | System-enforced |
| Error Risk | High (manual entry, transcription) | Significantly reduced |
| Traceability | Limited, manual | Full audit trail |
| Review Effort | Page-by-page | Review-by-exception |
| Data Integrity Strength | Variable | Architecturally embedded |
| Integration | Isolated | Connected ecosystem |
System-Enforced Compliance and Error Prevention
One of the greatest advantages of EBRs is their ability to prevent errors rather than detect them after the fact.
Modern EBR systems provide:
- Automated enforcement of critical process parameters, preventing execution outside of validated limits
- Real-time prompts requiring operators to complete checks before proceeding
- Interlocks that stop the process when prerequisite steps are incomplete
- Automated calculations and data capture, eliminating transcription errors
These capabilities shift the documentation paradigm from recording what happened to ensuring it happens correctly the first time.
Enhanced Data Integrity Through Digital Architecture
EBRs automatically embed data integrity into daily operations. By design, they support ALCOA++ principles more robustly than paper.
Benefits include:
- Tamper-evident entries and system-generated timestamps
- Integrated audit trails capturing every change
- Secure electronic signatures linked to unique user identities
- Direct data capture from equipment and sensors, reducing manual entry
This creates a batch record that is inherently more reliable, complete, and traceable, a critical expectation in modern GMP environments.
Streamlined Review and Review-by-Exception
In traditional paper systems, batch review requires page-by-page verification of entries. EBRs change this entirely through:
- Automated flagging of deviations or out-of-limit entries
- Digital linking of supporting records, such as equipment logs or IPC results
- Centralized dashboards that highlight only what requires QA attention
This concept of review-by-exception significantly reduces batch disposition timelines and is a major step toward accelerated release processes.
Connectivity with Equipment, LIMS, and Quality Systems
EBRs are becoming the central node of digital GMP ecosystems. Modern systems integrate seamlessly with:
- Process equipment (SCADA, PLC, PAT tools)
- Laboratory Information Management Systems (LIMS)
- Electronic Quality Management Systems (eQMS)
- Automation and IoT platforms
This creates a single source of truth for each batch, improves traceability, and reduces the risk of inconsistent or duplicated data across systems.
Enabling Real-Time Release and Advanced Quality Models
As regulators encourage the use of PAT (Process Analytical Technology) and science-based control strategies, EBRs become foundational to real-time release testing (RTRT) and continuous manufacturing.
EBRs support:
- real-time monitoring of CQAs and CPPs
- automated decision rules based on validated models
- data-driven verification of process performance
- integration of PAT outputs directly into the batch record
This positions EBRs as a critical component of future control strategies where process data, not just end-product testing, supports release decisions.
The Shift Toward Fully Digital Manufacturing
Over the next decade, EBRs are expected to evolve even further as part of broader digital transformation initiatives in GMP:
- Cloud-based MES systems with validated environments
- AI-assisted deviation detection and batch review
- Advanced analytics identifying trends across batches
- Digital twins of processes for simulation and optimization
- Automated execution with minimal manual input
These advancements will not change the regulatory principles behind batch records, but they will change how manufacturers demonstrate process control and product quality.
Regulatory Requirements for Batch Records
Batch documentation is one of the most regulated areas of pharmaceutical GMP. While terminology and structure may differ across companies, the regulatory expectations are consistent: batch records must demonstrate that each batch was manufactured, packaged, tested, and reviewed in accordance with approved procedures, under a state of control, and with full data integrity.
The following sections summarize the key regulatory requirements from EU GMP, FDA (21 CFR 211), and ICH Q7 that directly impact the creation, maintenance, and review of batch records.
ЕU GMP Requirements
EU GMP provides a detailed framework for documenting manufacturing and packaging operations. The core requirements appear in Part I (Chapters 4 and 5) and Annex 16.
Key expectations:
- Chapter 4 (Documentation):
- All manufacturing and packaging activities must be recorded at the time they are performed.
- Entries must be clear, legible, and attributable.
- Documented evidence must demonstrate compliance with the approved instructions.
- Any correction must leave the original entry legible and must be justified and signed.
- Chapter 5 (Production):
- Manufacturing must follow predefined instructions (MBR) that reflect the validated process.
- Batch records must provide a complete history of each batch, including any deviations.
- Reconciliation of materials and yield calculations must be documented.
- Packaging records must be maintained for each batch, with special attention to printed materials.
- Annex 16 (Certification by a Qualified Person):
- The QP must have access to the complete batch documentation package.
- Batch records must clearly demonstrate compliance with the MA/CMC, GMP, and Quality System.
- Documentation must be complete before batch certification.
- Any deviations must be investigated and resolved before certification.
FDA Requirements: 21 CFR Part 211
The FDA provides some of the most explicit requirements for batch records. The relevant sections are §211.186, §211.188, and §211.130.
Master Production and Control Records — §211.186
FDA requires:
- A master manufacturing record for each product
- Clear, specific instructions with defined components, equipment, and calculations
- Justification for any deviations from theoretical quantities
- Approval signatures from production and quality control
Batch Production and Control Records — §211.188
A compliant BMR must include:
- Complete information relating to the production and control of each batch
- Documentation of each significant step
- Actual data recorded contemporaneously
- Identification of persons performing and checking each operation
- Investigation results for any discrepancy or failure
Packaging and Labelling Controls — §211.130
FDA requires:
- Line clearance to prevent mix-ups
- Examination of packaging materials for correctness
- Electronic or written documentation of checks
- Reconciliation of labels and printed items
- Control of non-conforming components
FAQ
What Is the Difference Between a Master Batch Record and a Master Formula?
A Master Batch Record (MBR) and a Master Formula describe the same manufacturing process, but the MBR is a broader, more operational document. The Master Formula typically focuses on the composition, quantities, and theoretical yields, while the MBR expands these into step-by-step manufacturing instructions.
Many companies use the terms interchangeably, but regulators expect the MBR to include all production-relevant details. The Master Formula forms the scientific foundation, while the MBR translates it into GMP-controlled execution steps.
How Often Should Master Batch Records Be Reviewed or Revised?
There is no fixed regulatory frequency, but MBRs must be reviewed when there is a process change, equipment upgrade, deviation trend, or regulatory update. Many companies perform periodic reviews every 1–3 years as part of continuous improvement.
The purpose of these reviews is not routine editing but ensuring the MBR still reflects the validated, approved process. If any part is outdated or unclear, change control is required before releasing a new version.
What Is the Role of Batch Records in Technology Transfer?
Batch records are critical during technology transfer because they provide a structured comparison between the sending and receiving sites. The MBR is often rebuilt to reflect local equipment and environmental conditions while maintaining alignment with the approved process.
BMRs from engineering or demonstration batches help identify gaps, deviations, or new risks. Regulators expect transferred processes to have fully harmonized documentation before routine manufacturing begins.
How Long Must Batch Records Be Retained?
Retention times depend on regional regulations. In the EU, batch records must be kept for at least 1 year after the batch’s expiry date. FDA regulations require retention for at least 1 year after the batch’s expiration date or 3 years after distribution, whichever is longer.
For APIs under ICH Q7, a minimum of 3 years after batch manufacture is required. Companies may choose longer retention times based on risk, product lifecycle, or market requirements.
Can Reworks and Reprocessing Be Included in Batch Records?
Yes, but rework or reprocessing steps must be clearly documented and justified. Any deviation from the approved process requires QA assessment and, in many cases, regulatory notification. Batch records must include the exact steps taken, the rationale, and supporting analytical results. Failure to document rework correctly is a repeated FDA inspection finding.
How Do Batch Records Support Investigations Such as OOS or Deviations?
Batch records provide the factual timeline needed to reconstruct events leading to atypical results. Inspectors and investigators review BMRs, equipment logs, and QC data to identify potential root causes. Missing or inconsistent data in batch records can hinder or invalidate an investigation. High-quality documentation accelerates investigation closure and strengthens corrective actions.
Are Electronic Signatures Legally Valid for Batch Records?
Yes, when implemented in accordance with Annex 11 and 21 CFR Part 11 requirements. Electronic signatures must be uniquely attributable, linked to secure accounts, and protected against tampering. They must include the signer’s identity, date, and meaning of the signature (e.g., performed, checked, approved). Proper validation ensures electronic signatures are legally equivalent to handwritten ones.
Final Thoughts
Batch records are the core documentation supporting batch review, release, and regulatory compliance in pharmaceutical manufacturing. Each type: master, production, packaging, analytical, and supporting equipment records, serves a specific purpose and provides evidence that the batch was executed as approved.
When these documents are complete, consistent, and aligned with the validated process, they give QA the information needed to assess the batch with confidence.
As the industry moves toward digital systems, the structure of batch records remains the same, but the way they are created and verified is changing. Electronic Batch Records and data-driven tools are improving traceability, reducing manual errors, and making the review process more efficient. Regardless of format, the expectation remains the same: batch records must accurately reflect what happened and provide a reliable foundation for decision-making.
