Standard Operating Procedure (SOP) for Batch Record Review

Standard Operating Procedure (SOP) for Batch Record Review

1.0 Purpose

This SOP outlines the procedure for reviewing batch records to ensure compliance with regulatory requirements and internal quality standards.

2.0 Scope

This procedure applies to all personnel involved in the review of batch records within the manufacturing facility.

3.0 Responsibilities

3.1 Quality Assurance (QA) Department:

  • Review batch records for accuracy and compliance.
  • Document findings and any discrepancies identified during the review process.
  • Communicate with relevant departments to address and resolve any issues found.

3.2 Production Department:

  • Complete batch records accurately and in accordance with established procedures.
  • Notify QA of any deviations or discrepancies encountered during production.

4.0 Procedure 4.1 Retrieval of Batch Records:

  • Retrieve the batch records from the designated storage area.
  • Ensure that the batch records are complete and include all required documentation.

4.2 Initial Review:

  • Verify that the batch records are filled out legibly and completely.
  • Check for any missing signatures or entries.
  • Confirm that calculations and data entries are accurate.

4.3 Compliance Check:

  • Compare the information in the batch records with the master production documents, including batch production records (BPRs), standard operating procedures (SOPs), and specifications.
  • Ensure that all manufacturing processes were conducted in compliance with regulatory requirements and internal procedures.
  • Verify that any deviations or non-conformances were appropriately documented and investigated.

4.4 Product Quality Review:

  • Assess the quality of the finished product based on the information provided in the batch records.
  • Review in-process testing results, including raw material testing, in-process controls, and final product testing.
  • Confirm that all quality control checks were performed as required and that the product meets established specifications.

4.5 Documentation Review:

  • Evaluate the completeness and accuracy of all documentation, including batch records, logbooks, and any additional forms or reports.
  • Ensure that all necessary attachments, such as laboratory test results and batch reconciliation reports, are included and properly filed.

4.6 Final Approval:

  • Once the review is complete and any discrepancies have been addressed, provide final approval for the batch records.
  • Sign and date the batch records to indicate completion of the review process.

5.0 Records Retention

  • Retain reviewed batch records in accordance with established document retention policies.
  • File batch records in the designated storage area for easy retrieval and future reference.

6.0 Training

  • Ensure that personnel involved in batch record review are adequately trained on this SOP and understand their responsibilities.
  • Provide refresher training as needed to maintain competency and compliance with procedures.

7.0 References

List any relevant regulatory guidelines, company policies, or industry standards applicable to batch record review.

8.0 Definitions

Define any terms or abbreviations used throughout the SOP for clarity and consistency.

9.0 Revision History

Document any revisions made to this SOP, including the date of revision and a brief description of the changes.

10.0 Attachments

Include any templates, forms, or checklists used in the batch record review process as attachments to this SOP.

11.0 Approval

This SOP is approved by the Quality Assurance Manager or another designated individual responsible for quality oversight within the organization.

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