Standard Operating Procedure (SOP) for Batch Record Issuance and Control

1. Purpose

To define the standardized process for the issuance, control, and retrieval of batch records to ensure accurate and complete documentation in compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to the Quality Assurance (QA) department and other relevant departments involved in the preparation, issuance, control, and archival of batch records for all production batches.

3. Responsibility

• Quality Assurance (QA) Personnel: Responsible for preparing, issuing, controlling, and retrieving batch records as per SOP.
• Production Personnel: Responsible for ensuring that batch records are accurately completed and maintained during the production process.
• Quality Control (QC) Personnel: Responsible for verifying data entries and signing off on completed batch records.
• Head of QA: Responsible for reviewing and approving the SOP, ensuring adherence, and conducting periodic audits of batch records.

4. Definitions

• Batch Record (BR): A document that records all production data associated with a particular batch of product, including materials, processes, tests, and results.
• Issuance: The process of releasing an authorized and unique batch record for production.
• Control: The monitoring of batch records to ensure completion, accuracy, and compliance with regulatory requirements.
• Retrieval: The process of returning completed and reviewed batch records to QA for archival.

5. Procedure

5.1 Batch Record Preparation

• Batch Record (BR): A controlled document detailing the manufacturing steps, materials, and testing required for a production batch.
• Master Batch Record (MBR): A standardized template used for creating individual batch records.
• Batch Number: A unique identifier assigned to each batch produced.

5.2.1 Preparation of Master Batch Record (MBR)

1. Template Design:
   • QA is responsible for designing a Master Batch Record (MBR) template for each product based on approved process documentation, including the Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR).
   • The MBR template should include sections for all critical manufacturing and quality processes, such as:
     • Materials: List of raw materials, intermediates, and excipients.
     • Equipment: List of equipment required with ID and calibration status.
     • Production Process: Detailed manufacturing steps, including mixing, granulation, drying, blending, and packaging.
     • In-Process Controls: Parameters to be monitored and control limits.
     • Quality Control Checks: Tests required, including sampling plans, specifications, and acceptance criteria.
2. Template Content Requirements:
   • Include specific information for each section to ensure that data is complete and GMP-compliant, such as:
     • Product name, strength, and batch size.
     • Detailed process instructions and precautions.
     • Space for actual data entries, observations, and comments.
     • Signatures of personnel responsible for each stage.
3. Document Control and Formatting:
   • Assign a unique document control number, version number, and effective date to each MBR template.
   • All MBR templates should be in controlled format with page numbers, revision history, and sections clearly labeled.
   • Any changes to the template must follow a formal change control process and be documented with justification, approval, and version control.

5.2.2 Review and Approval of MBR Template

1. Initial Review by QA:
   • QA personnel review the MBR template for accuracy, completeness, and compliance with GMP guidelines.
   • Verify that each section aligns with the approved manufacturing process, quality standards, and regulatory requirements.
2. Cross-Functional Review:
   • Share the draft template with Production, QC, and any other relevant departments for input and review to ensure all required details are covered.
3. Approval Process:
   • The final draft of the MBR template is reviewed by the Head of QA or designated authority.
   • Upon approval, the template is signed, dated, and recorded in the Master Batch Record Log for controlled use in production.

5.2.3 Preparation of Batch-Specific Record

1. Batch Information Entry:
   • QA enters batch-specific information such as batch number, manufacturing date, and expiration date based on production planning.
   • Review and verify that all batch-specific details align with product specifications and batch requirements.
2. Material Specifications and Quantities:
   • Enter the batch-specific quantities of raw materials, excipients, and intermediates.
   • Include quality specifications and acceptance criteria for each material to be used.
3. Production Process Details:
   • Fill in process-specific details, such as exact times, temperatures, mixing speeds, and durations required for the batch.
   • Include parameters for in-process checks with pre-defined control limits to monitor during production.
4. Quality Control Specifications:
   • Specify the sampling procedures, frequency, and quality tests required.
   • Enter target acceptance criteria for product quality attributes such as potency, uniformity, and stability.

5.2.4 Issuance of Batch Record for Production

1. Batch Record Control Number:
   • Assign a unique control number to each batch record before issuance to avoid duplication and ensure traceability.
2. Documentation and Log Entry:
   • Record the issuance in the Batch Record Logbook, including batch number, date of issuance, and signature of the QA issuer.
3. Issuance to Production:
   • Stamp the batch record with “Issued for Production” and securely transfer it to the production department for completion during manufacturing.

5.2.5 Training and Guidance for Production Personnel

1. Training:
   • QA provides training to production personnel on the accurate and complete filling of batch records, including documentation best practices and regulatory requirements.
2. Guidance on Documentation Practices:
   • Production personnel are instructed to document entries in real-time and in ink, avoiding erasures or overwriting.
   • Corrections should be made by crossing out errors with a single line, initialing, and dating.

5.2.6 Revision and Updates of MBR Templates

1. Periodic Review:
   • Review all MBR templates at regular intervals, such as annually or upon significant process changes, to ensure compliance and relevance.
2. Change Control Process:
   • All updates or revisions to MBR templates must go through a formal change control process.
   • Document the reasons for the update, obtain necessary approvals, and assign a new version number.

5.2.7 Archival of Batch Records

1. Record Maintenance:
   • Maintain both the master batch record templates and completed batch-specific records in a secure and controlled environment.
2. Retention Period:
   • Retain batch records as per regulatory requirements (typically at least five years), following which they may be disposed of per the Document Destruction SOP.

6. Related Documents

• SOP for Document Control and Archival
• Batch Record Logbook
• SOP for Document Destruction
• SOP for Change Control Process

7. Record Keeping

All records generated as part of this SOP, including the Master Batch Record Log and individual batch records, are to be maintained by QA for compliance audits and regulatory reviews.

5.2 Batch Record Issuance

1. Issuance Request:
   • The production team submits a request for batch record issuance to QA at least [insert timeline, e.g., 24 hours] before production starts.
2. Issuance Process:
   • QA retrieves the relevant template and prints the required number of copies.
   • Each issued batch record must have a unique batch number, which is generated following a predefined numbering convention.
   • QA stamps or labels each batch record with “Issued for Production” and records the issuance details in a Batch Record Logbook, including the batch number, date of issuance, and recipient’s signature.
3. Controlled Copy:
   • Only the QA department is authorized to issue batch records; unauthorized copies are strictly prohibited.
   • Issued records should be marked as “Controlled Copy” and numbered sequentially to avoid duplication.

Procedure

5.1 Preparation for Issuance

1. Review of Master Batch Record (MBR):
   • Ensure that the Master Batch Record (MBR) has been approved by QA and is up to date before preparing individual batch records.
   • Confirm that the MBR meets all regulatory and production specifications and has no pending revisions.
2. Batch Record Template Generation:
   • Use the MBR as a template to generate batch-specific records by adding details like batch number, manufacturing date, and expected expiration date.
   • Include production-specific parameters for each stage as per the MBR.
3. Initial Verification:
   • QA personnel should verify that all batch-specific information is correct, complete, and legible before proceeding with issuance.

5.2 Document Control and Tracking

1. Assign Batch Control Number:
   • Each batch record is assigned a unique control number or batch number for tracking and traceability.
   • Record the batch number, date of issuance, and QA personnel’s signature in the Issuance Logbook to maintain a record of issuance.
2. Entry in the Issuance Logbook:
   • Log each issuance in the controlled Batch Record Issuance Logbook, capturing the following details:
     • Batch number
     • Product name
     • Issuance date
     • Quantity of batch records issued (if multiple copies are needed)
     • Signature of QA personnel and receiving personnel from the production team
3. Document Stamp and Control:
   • Stamped with “Issued” to indicate that the batch record has been authorized for use.
   • Batch records must be printed and issued as controlled copies, bearing control numbers, version numbers, and any required approval stamps.

5.3 Issuance of Batch Record to Production

1. Controlled Handover:
   • Hand over the batch record to authorized production personnel only.
   • Obtain the signature of the production personnel receiving the batch record to ensure accountability.
2. Instruction for Handling:
   • Instruct production personnel to maintain the batch record in a clean and accessible area in the production department.
   • Emphasize that batch records must be updated in real-time, documenting each step immediately after completion.
3. Real-Time Documentation:
   • QA should instruct production personnel to avoid backdating entries and to follow proper documentation practices, including signing and dating each entry as it is made.

5.4 Monitoring During Production

1. Random Checks by QA:
   • QA personnel should perform random checks to verify that production personnel are completing the batch record accurately and promptly.
   • Check for any discrepancies, missed entries, or errors in the documentation, and provide guidance on corrective actions if needed.
2. Real-Time Verification:
   • During production, QA may verify certain stages to ensure compliance with SOPs, including reviewing signatures, timestamps, and any deviations noted in the batch record.

5.5 Return and Archival of Completed Batch Records

1. Collection Post-Production:
   • Once production is completed, production personnel must return the completed batch record to QA for review.
   • Ensure that the batch record is intact, with all pages present and properly documented.
2. Review for Completeness:
   • QA reviews the completed batch record for accuracy, ensuring that all required fields are filled and any deviations are documented.
   • Sign and date the batch record to confirm the review.
3. Archival in Document Storage:
   • Place the reviewed batch record in a controlled archival storage area designated for batch records.
   • Retain the batch record for the duration specified by company policy and regulatory requirements.

5.6 Revision and Issuance of Updated Batch Records

1. Changes to MBR:
   • Any revision to the Master Batch Record (MBR) requires approval from QA and relevant departments, following the Document Control SOP.
2. Change Control Process:
   • Document and control any changes, including batch-specific adjustments or process improvements.
   • Once approved, update the issuance template to reflect the revision, assign a new version number, and maintain old versions in the document archive.
3. Issuance of Updated Records:
   • Once revised, issue the updated batch record template following the same issuance and logging process.

5.7 Handling Deviations

1. Documenting Deviations:
   • If any deviation occurs during production, production personnel must document it immediately in the batch record.
   • Describe the deviation clearly, including the nature, time, and personnel involved.
2. Deviation Review:
   • QA personnel must review each deviation entry, documenting actions taken to address the deviation.
   • Deviation reports are attached to the batch record and filed for future review and audit purposes.

6. Related Documents

• SOP for Document Control and Archival
• Batch Record Issuance Logbook
• SOP for Change Control Process
• SOP for Deviation Management

7. Record Keeping

• Batch Record Issuance Logbook
• Individual batch records
• Deviations and corrective action reports

5.3 Batch Record Control During Production

1. Record Maintenance:
   • Production personnel are required to fill out batch records accurately and in real-time, documenting all details of each step in the production process.
   • All data entries must be legible, complete, and made in ink. Erasures or overwriting are prohibited; corrections should be made by crossing out the error with a single line, initialing, and dating.
2. Monitoring:
   • QA personnel periodically monitor the production area to verify adherence to the documented procedures and confirm accurate completion of batch records.
3. In-Process Checks:
   • QC verifies critical data entries, such as equipment settings, raw material weights, and in-process control results.
   • Any deviations or non-conformances observed are documented and addressed as per the Deviation Management SOP.

5.3.1 Definitions

• Batch Record (BR): A document that records all instructions, specifications, and results for the manufacture of a specific batch.
• Real-Time Documentation: Immediate recording of production activities as they occur to ensure accuracy and compliance with regulatory standards.
• GMP Compliance: Adherence to Good Manufacturing Practices, which set guidelines for maintaining product quality, safety, and efficacy.

5.3.2 Procedure

5.3.2.1 Pre-Production Check

1. Receipt of Issued Batch Record:
   • Production personnel receive the issued batch record from QA, which includes verified and approved information, including the batch number, manufacturing date, and product specifications.
   • Verify that all necessary sections of the batch record are in place and complete before commencing production.
2. Verification of Entries:
   • Confirm that preliminary details (e.g., batch number, product name, quantity) are correct and legible.
   • Ensure that all equipment and material information required for the batch are correctly recorded prior to the start of the production process.
3. Pre-Production Authorization:
   • QA personnel should sign and date the batch record to authorize the start of production, confirming readiness to proceed.

5.3.2.2 Real-Time Documentation During Production

1. Immediate Entry of Information:
   • Production personnel must document each stage of the production process as it occurs, entering the following details:
     • Time and date of each operation.
     • Materials, equipment, and personnel involved in each process step.
     • Results, measurements, and observations for each step, including any deviations or observations.
2. Signature and Timestamp Requirement:
   • Each entry must be signed, dated, and time-stamped by the personnel performing the operation.
   • This ensures traceability and accountability for every action taken during production.
3. Avoiding Alterations and Corrections:
   • Avoid erasing or using correction fluid on the batch record. Any error should be struck through with a single line, initialed, and dated, with the correct information entered above or nearby.
   • Provide a brief note explaining the correction if necessary.
4. Review by Shift Supervisor:
   • The shift supervisor should periodically review batch records during production to ensure proper documentation.
   • If any discrepancies are identified, they should be corrected immediately following the correction procedure.

5.3.3.3 Handling Deviations During Production

1. Documenting Deviations:
   • If any deviation from the standard process occurs, document it immediately in the batch record, providing details such as:
     • Nature of the deviation
     • Cause (if known)
     • Immediate corrective actions taken
2. Deviation Reporting:
   • Notify QA immediately of any significant deviation that may impact the product quality or process. Attach a deviation report to the batch record.
   • Follow the established SOP for handling deviations to assess and document any impact on product quality.
3. Corrective and Preventive Actions (CAPA):
   • Document any corrective and preventive actions (CAPA) undertaken to address the deviation.
   • QA should review and sign off on the CAPA, ensuring it is adequately implemented before further production.

5.3.4.4 In-Process Checks and Monitoring

1. QA Spot Checks:
   • QA personnel perform random checks during the production process to ensure entries are accurate, timely, and compliant with SOPs.
   • QA verifies the integrity of data entries, especially for critical process steps, to ensure adherence to GMP.
2. Monitoring Critical Control Points:
   • Ensure critical process parameters (e.g., temperature, mixing time, pH) are recorded in real-time.
   • Confirm that required in-process checks, such as weight checks, are documented in the batch record by production personnel.
3. Documentation of Test Results:
   • Record all test results (e.g., weight variation, pH testing) at the specified intervals, noting any discrepancies immediately.
   • Test results should be reviewed by QA periodically during production to ensure the batch remains within acceptable limits.

5.3.5.5 Batch Record Handover at Shift Change

1. Documentation by Outgoing Personnel:
   • Outgoing personnel must ensure the batch record is fully updated before the end of their shift, including signing off completed sections.
   • Any ongoing tasks should be clearly noted for the incoming team to ensure a smooth transition.
2. Review by Incoming Personnel:
   • Incoming personnel should review the batch record, verify the entries, and confirm that they understand any instructions or ongoing tasks.
   • Sign and date the batch record to indicate the transfer of responsibility.
3. Shift Supervisor Oversight:
   • Shift supervisors should verify that handover entries are complete and correct to prevent any loss of information or oversight during shift transitions.

5.3.6.6 Completion of Batch Production

1. Final Review of Batch Record:
   • Production personnel must review the completed batch record to confirm that all steps are documented, with no missing entries or information.
   • The batch record should be organized in sequential order, ensuring that every page is signed and dated.
2. QA Verification:
   • QA personnel conduct a detailed review of the completed batch record for accuracy and completeness, checking for any discrepancies, missing entries, or documentation errors.
   • Any identified issues must be resolved and corrected before final approval.
3. Submission to QA for Archival:
   • Submit the finalized batch record to QA for archival. QA will file the record in a secure, controlled document storage area for future reference, as per SOP for document control.

5.3.7.7 Handling Discrepancies and Corrections

1. Identification of Discrepancies:
   • Production personnel should report any discrepancies identified during documentation to QA for review.
   • QA personnel should evaluate the discrepancy to determine if it impacts product quality and initiate corrective actions as required.
2. Correction Procedure:
   • Follow correction procedures as outlined: use a single line to strike out incorrect entries, followed by initials, date, and correct information.
   • Attach a discrepancy report if necessary and document any corrective action taken.

6. Related Documents

• SOP for Document Control and Archival
• SOP for Deviation Management
• SOP for Batch Record Issuance
• In-Process Control Forms

7. Record Keeping

• Batch Records
• Deviation Reports and CAPA
• QA Inspection Logs
• Batch Record Issuance and Handover Log

5.4 Batch Record Retrieval and Review

1. Submission to QA:
   • Upon production completion, the production team submits the batch record to QA for final review within [insert timeline, e.g., 24 hours].
2. Initial QA Review:
   • QA personnel conduct a thorough review, ensuring that:
     • All fields are filled accurately and completely.
     • Signatures and dates are present for each section.
     • Corrections (if any) follow the approved correction procedure.
   • Discrepancies or missing information are communicated to production for correction.
3. Final QA Approval:
   • The QA Head or a designated official performs a final check. If the record is complete, it is approved, and QA stamps it with “Final Approval” or equivalent.

5.4.1 Procedure

5.1 Batch Record Retrieval

1. Request for Retrieval:
   • When batch records are needed for review, authorized QA personnel must submit a formal retrieval request to the document control unit.
   • Include details such as batch number, product name, production date, and any specific sections of the batch record if partial retrieval is required.
2. Verification and Authorization:
   • The document control unit verifies the request for completeness and checks the retrieval authorization level.
   • Only personnel with authorized access, as per the access control list, may retrieve and handle batch records.
3. Record Collection:
   • Upon authorization, retrieve the requested batch record(s) from the controlled document storage area, ensuring careful handling to maintain the integrity of the record.
   • Batch records should not be left unattended and should be logged out in the retrieval log with date, time, batch number, and handler’s name.
4. Temporary Storage for Review:
   • Place the retrieved batch records in a designated temporary storage area near the QA office, maintaining security and access restrictions.
   • Record the temporary storage details and anticipated review period in the batch retrieval log.

5.2 Batch Record Review Process

5.2.1 Initial Review by QA Personnel

1. Documentation Completeness:
   • QA personnel review the batch record to ensure all documentation sections are complete and legible, including:
     • Production entries
     • Quality control results
     • Signatures and timestamps
     • Deviation reports, if applicable
2. Verification of Critical Data:
   • Verify that critical information (e.g., batch number, product specifications, materials used) is consistent across all documentation sections.
   • Cross-check recorded values with specifications to ensure compliance with established quality standards.
3. Entry Accuracy:
   • Ensure that all documented entries are accurate and aligned with production protocols.
   • Check for any overwritten data or unauthorized corrections, and verify that all corrections were performed in compliance with SOPs.

5.2.2 Detailed Review of Specific Sections

1. Production Section Review:
   • Check that all production steps are documented in chronological order and that personnel signatures are present.
   • Verify that each production step was performed within approved parameters, such as time, temperature, and pressure, as applicable.
2. Quality Control Testing Review:
   • Review QC testing data, including results for raw material and finished product testing, to confirm adherence to approved specifications.
   • Check that all test records, instrument calibration records, and analyst signatures are complete and accurate.
3. Deviation and Non-Conformance Review:
   • If deviations or non-conformances were reported, review the associated reports for proper documentation and investigation.
   • Ensure that appropriate corrective and preventive actions (CAPA) were implemented and documented in the batch record.
4. Cleaning and Maintenance Records:
   • Verify that cleaning and maintenance logs for equipment used in production are included in the batch record and completed as required by SOPs.
5. Environmental Monitoring Records (if applicable):
   • Check environmental monitoring results for areas where the product was manufactured to ensure compliance with environmental control requirements.

5.2.3 Final Review and Documentation

1. QA Final Review and Approval:
   • The QA reviewer performs a final review of the entire batch record for completeness and accuracy.
   • If no discrepancies are found, the QA reviewer signs and dates the final review section, approving the batch record for archival.
2. Identification of Discrepancies:
   • If any discrepancies, missing information, or irregularities are identified, document these findings in a Batch Record Discrepancy Report.
   • Attach the discrepancy report to the batch record and notify the Head of QA for further investigation.
3. Resolution of Discrepancies:
   • QA collaborates with relevant personnel to resolve discrepancies, completing any necessary investigations and implementing corrective actions.
   • Document the actions taken, and upon satisfactory resolution, approve the batch record for finalization.

5.3 Batch Record Filing and Archival

1. Final Approval and Archival:
   • Once the review process is complete and all discrepancies resolved, the batch record is signed by the Head of QA for final approval.
   • Prepare the batch record for long-term storage according to document control procedures, ensuring all documents are securely bound and labeled.
2. Record Indexing and Storage:
   • Assign an archival code or reference number to the batch record and update the Document Control System with the indexing information.
   • Place the batch record in a secure, temperature-controlled archival area, restricting access to authorized personnel only.
3. Retention Period and Disposal:
   • Retain batch records for the duration specified by regulatory requirements and company policy.
   • At the end of the retention period, records may be disposed of per document destruction SOPs, with proper authorization and documentation of disposal.

5.4 Documentation and Logs

1. Batch Record Retrieval Log:
   • Maintain a log for all retrieved batch records, including batch number, retrieval date, purpose of retrieval, and handler details.
   • Update the log with the date of return or archival to ensure accurate tracking of batch record movements.
2. Batch Record Review Checklist:
   • Use a checklist during the review process to document each review step, including sign-offs by the QA reviewer and any discrepancies identified.
   • Attach the completed checklist to the batch record as part of the final documentation.
3. Discrepancy Reports and CAPA Records:
   • Maintain copies of discrepancy reports and CAPA records associated with each batch record.
   • Ensure these records are filed together for quick reference during audits or inspections.

5.5 Batch Record Archival

1. Record Archival:
   • Completed and approved batch records are securely archived in the QA document control room.
   • Batch records should be stored in a designated, controlled-access area to ensure integrity and confidentiality.
2. Retention Period:
   • Retain batch records as per regulatory requirements, typically a minimum of five years, unless specified otherwise by product-specific regulations.
3. Destruction of Expired Records:
   • Once retention requirements are fulfilled, batch records may be destroyed as per the Document Destruction SOP, with QA approval and a destruction log entry.

6. Related Documents

• SOP on Deviation Management
• SOP on Document Control and Archival
• Batch Record Logbook
• SOP on Document Destruction

7. Record Keeping

All records generated as part of this SOP, including the Batch Record Logbook and issuance forms, shall be maintained by QA for regulatory review and internal audits.

8. References

• Good Manufacturing Practices (GMP) guidelines
• Regulatory requirements (e.g., FDA, WHO, EMA)

9. Revision History

Revision No.	Effective Date	Description of Changes	Author
1.0	[Insert Date]	New SOP	[Name]

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