Standard Operating Procedure for Batch Record Review and Approval in Tablet Manufacturing

Department	Tablet
SOP No.	SOP/TAB/171/2025
Supersedes	SOP/TAB/171/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define the procedure for reviewing and approving batch records in tablet manufacturing, ensuring that all relevant data, processes, and approvals are documented and compliant with regulatory requirements before proceeding with production.

2. Scope

This SOP applies to the review and approval of batch records for tablet manufacturing, covering all stages of production, from raw material receipt to final product approval.

3. Responsibilities

• Production Operator: Responsible for ensuring that all data entered into the batch record is accurate and complete during the manufacturing process.
• Quality Control (QC): Responsible for verifying that all batch record entries align with quality standards and testing results, and that the batch is compliant with specifications.
• Quality Assurance (QA): Ensures that batch records are reviewed and approved according to this SOP, and verifies compliance with GMP and regulatory standards.

4. Accountability

The Production Supervisor is accountable for ensuring that batch records are completed accurately during the manufacturing process. The QA Manager is responsible for reviewing and approving the batch records to ensure compliance with internal and regulatory standards.

5. Procedure

5.1 Completion of Batch Records

1. Ensure that all required fields in the batch record are completed during the production process, including raw material lot numbers, quantities, batch details, and any test results conducted during manufacturing.
2. Verify that the data entered into the batch record is consistent with the approved process, including manufacturing procedures, equipment settings, and quality control checks.
3. Ensure that all necessary signatures are obtained at each stage of the manufacturing process, including the production operator, QC, and QA, as applicable.

5.2 Initial Review by Quality Control

1. QC is responsible for conducting an initial review of the batch record, ensuring that all quality control tests and inspections have been performed as required by the batch record.
2. QC will verify that the results from in-process testing, final product testing, and any other required quality checks are accurately recorded in the batch record.
3. Any discrepancies identified during the initial review should be documented in the deviation report (Annexure-1) and resolved before further review or approval can proceed.

5.3 Final Review and Approval by Quality Assurance

1. QA is responsible for conducting the final review of the batch record to ensure that all required fields are completed, all signatures are obtained, and all QC and production activities comply with GMP standards.
2. QA will review the batch record for any discrepancies, such as missing information, incomplete signatures, or deviations that have not been adequately addressed.
3. If the batch record meets all requirements and no further action is needed, QA will approve the batch record for release and proceed to the next manufacturing step or product release.
4. If discrepancies are found during the final review, QA will communicate with the production team to address and resolve the issues before final approval.

5.4 Documentation and Record Retention

1. Once the batch record is approved by QA, it should be stored in the appropriate electronic or physical archive according to the company’s document retention policy.
2. Ensure that all records are readily accessible for audits and inspections by regulatory authorities, maintaining traceability of each batch throughout the production process.

5.5 Corrective Actions for Batch Record Discrepancies

1. If any discrepancies are found during the batch record review process, initiate corrective actions as follows:
   • Document the discrepancy in the deviation report (Annexure-1).
   • Investigate the root cause of the discrepancy, whether due to human error, equipment malfunction, or other factors.
   • Implement corrective actions, such as retraining personnel, re-calibrating equipment, or updating procedures to prevent recurrence.
2. After corrective actions are implemented, recheck the batch record and associated data to ensure compliance before proceeding with final approval.

5.6 Approval of Final Batch Records

1. Once all discrepancies are addressed and the batch record is complete, QA will grant final approval for the batch record, allowing the batch to move to the next stage of manufacturing or packaging.
2. QA will sign and date the batch record to confirm final approval, ensuring that all required documentation is accurate and complete.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action

7. Documents

1. Batch Record (Annexure-2)
2. Deviation Report (Annexure-1)

8. References

• USP <701> – Guidelines for Tablet Manufacturing
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• European Pharmacopoeia (EP) – Batch Documentation Requirements

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
15/12/2025	Batch 001	Missing signature on quality control testing	Retrained QC personnel and obtained missing signature	John Doe

Annexure-2: Batch Record

Step	Data Entry	Reviewed By	Signature
Initial Review	All fields complete	Jane Smith	Signature
Final Review	Compliance confirmed	John Doe	Signature

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated batch review process	Streamlined review procedure	QA Head