1) SOP for Batch Record Review

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the systematic review and verification of batch records to ensure accuracy and compliance with regulatory and company standards before batch release and approval.

3) Scope

This SOP applies to all personnel involved in the review and approval of batch records within the pharmaceutical manufacturing facility.

4) Responsibilities

• Production personnel are responsible for completing batch records accurately and completely.
• Quality Assurance (QA) personnel are responsible for reviewing and verifying the batch records for accuracy and compliance.
• Supervisors are responsible for ensuring that batch records are reviewed and approved in a timely manner.

5) Procedure

1. Initial Review by Production
   1. Ensure all batch records are completed accurately and legibly by the production personnel.
   2. Verify that all required fields are filled out, including dates, signatures, and production parameters.
   3. Check for any discrepancies or deviations noted during the production process.
   4. Document any corrections or clarifications needed and return the batch record to the responsible personnel for completion.
2. QA Review
   1. Upon receipt of the completed batch record, QA personnel should verify the completeness and accuracy of the documentation.
   2. Ensure all critical process parameters and quality attributes are within the specified limits.
   3. Review any deviations, investigations, or corrective actions documented in the batch record.
   4. Check that all required signatures and dates are present and correct.
   5. Compare the actual yield against the theoretical yield to ensure it falls within acceptable limits.
   6. Verify that any test results or certificates of analysis (COAs) are attached and meet the acceptance criteria.
3. Resolving Discrepancies
   1. If any discrepancies, errors, or omissions are identified during the QA review, document these issues and notify the relevant production personnel for resolution.
   2. Ensure that all discrepancies are resolved and documented appropriately in the batch record.
   3. Conduct a re-review of the corrected batch record to verify the resolution of discrepancies.
4. Final Approval
   1. Once the QA review is complete and any discrepancies have been resolved, the batch record should be submitted for final approval.
   2. The QA Manager or designated personnel should conduct a final review and sign off on the batch record, indicating approval.
   3. Document the final approval in the batch record, including the date and signature of the approving authority.
5. Batch Record Archival
   1. After final approval, batch records should be archived according to company policy.
   2. Ensure that batch records are stored in a secure and easily retrievable manner for future reference.
   3. Document the archival process in the batch record tracking log.

6) Abbreviations, if any

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• COA: Certificate of Analysis

7) Documents, if any

• Batch Record
• Batch Record Tracking Log
• Certificates of Analysis (COAs)

8) Reference, if any

• Current Good Manufacturing Practice (cGMP) guidelines
• Company-specific batch record review guidelines

9) SOP Version

Version 1.0