Standard Operating Procedure for Batch Record Review and Approval

1) Purpose

This SOP outlines the procedures for the review and approval of batch records to ensure that each batch of pharmaceutical product is manufactured in compliance with regulatory standards and company policies before release.

2) Scope

This SOP applies to all batch records generated during the production of pharmaceutical products within the company.

3) Responsibilities

The Quality Assurance (QA) department is responsible for implementing and maintaining this SOP. The QA team ensures that all batch records are thoroughly reviewed and approved before any batch is released.

4) Procedure

4.1 Collection and Compilation of Batch Records

1. Gather all documents and records related to the batch, including the Batch Production Record (BPR), in-process control records, and any deviation reports.
2. Ensure that all documents are complete and signed by the responsible personnel.

4.2 Initial Review

1. Conduct an initial review of the batch records to verify that all manufacturing steps were performed as per the approved procedures.
2. Check that all critical control points and critical quality attributes (CQAs) are within specified limits.
3. Document any discrepancies or deviations noted during the initial review.

4.3 Detailed Review

1. Perform a detailed review of the batch records, focusing on the completeness, accuracy, and compliance with standard operating procedures (SOPs) and regulatory requirements.
2. Verify the reconciliation of all materials used and ensure there are no unexplained discrepancies.
3. Review all in-process and final product testing results to confirm they meet the predefined specifications.

4.4 Handling Deviations and Discrepancies

1. Identify and document any deviations or discrepancies found during the detailed review.
2. Investigate the root cause of each deviation or discrepancy and determine its impact on the batch quality.
3. Implement corrective actions as necessary and document them in the deviation report.

4.5 Approval or Rejection

1. Compile all review findings and documentation for final approval by the QA Manager.
2. Approve the batch for release if it meets all quality and compliance requirements, and sign the Batch Record Approval Form.
3. Reject the batch if it does not meet the required criteria, quarantine it, and initiate an investigation report.

4.6 Documentation and Record Keeping

1. Ensure all batch records, review documents, and approval forms are accurately completed and signed.
2. Store all records securely and ensure they are readily accessible for audits and regulatory inspections.

5) Abbreviations, if any

QA: Quality Assurance
BPR: Batch Production Record
CQA: Critical Quality Attribute
SOP: Standard Operating Procedure

6) Documents, if any

Batch Production Records, Deviation Reports, Batch Record Approval Forms, Review Documents

7) Reference, if any

Regulatory guidelines such as FDA, EMA, ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients), and ICH Q10 (Pharmaceutical Quality System)

8) SOP Version

Version 1.0