Standard Operating Procedure for Batch Record Review and Approval

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the systematic and thorough review and approval of batch records in the pharmaceutical manufacturing facility. This SOP ensures that each batch record is meticulously examined for accuracy, completeness, and compliance with approved procedures and regulatory requirements before approval for product release.

2. Scope

This SOP applies to all personnel involved in the batch record review and approval process, including quality assurance staff, quality control personnel, and production supervisors.

3. Responsibilities

• Quality Assurance (QA) Department: Responsible for conducting a detailed review of batch records to verify compliance with approved procedures and product specifications.
• Quality Control (QC) Personnel: Responsible for providing QC testing data and results for inclusion in the batch record.
• Production Supervisor: Responsible for coordinating with the QA and QC teams to ensure timely review and approval of batch records.
• Regulatory Affairs: Responsible for verifying regulatory compliance and documentation before batch record approval.

4. Procedure

4.1 Batch Record Compilation:

• Collect all relevant data, test results, and documentation related to the batch production process, including production records, quality control data, and any deviations or non-conformances encountered.
• Assemble the batch record in a standardized and organized manner for ease of review and verification.
• Include all required information, such as product name, batch number, manufacturing date, and details of the manufacturing process.

4.2 Review of Batch Record:

• Thoroughly review the batch record to ensure that all steps and procedures were followed correctly during the manufacturing process.
• Verify that all critical process parameters and quality control tests are within the specified limits and meet the product specifications.
• Check for any deviations, discrepancies, or non-conformances and ensure that they have been properly investigated and documented.
• Ensure that the data entries in the batch record are clear, complete, and legible.

4.3 Regulatory Compliance:

• Verify that the batch record complies with all applicable regulatory requirements, including Good Manufacturing Practices (GMP) and other relevant guidelines.
• Review any necessary regulatory approvals or clearances before approving the batch record for release.
• Ensure that all labeling and packaging requirements are met in accordance with regulatory guidelines.

4.4 Batch Record Approval:

• Based on the review findings and verification of regulatory compliance, the QA department will make a decision to approve or reject the batch record.
• If the batch record meets all criteria and requirements, it will be approved for product release.
• If any issues or discrepancies are identified, appropriate corrective actions must be taken before approving the batch record.
• Document the batch record approval decision, including any notes or recommendations, in the batch record itself.

5. Abbreviations

SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
GMP: Good Manufacturing Practices

6. Documents

The following documents are relevant to this SOP:

• Batch Record Review and Approval Form
• Batch Record Compilation Checklist
• Regulatory Compliance Checklist

7. References

No specific external references are required for this SOP as it is based on internal company procedures and regulatory guidelines.

8. SOP Version

This is version 1.0 of the SOP for Batch Record Review and Approval, effective as of [Insert Date].