Standard Operating Procedure for Batch Record Keeping

Purpose

The purpose of this SOP is to establish procedures for the accurate and systematic documentation of batch records, ensuring traceability, compliance with regulatory standards, and maintaining a comprehensive record of each pharmaceutical product batch.

Scope

This SOP applies to all personnel involved in the batch record keeping process, including operators, quality control personnel, and documentation specialists.

Responsibilities

• Operators: Responsible for documenting key operational steps and observations during the manufacturing process.
• Quality Control Personnel: Responsible for reviewing and approving batch records for accuracy and compliance with specifications.
• Documentation Specialists: Responsible for organizing, maintaining, and archiving batch records in accordance with established procedures.

Procedure

1. Start the batch record at the beginning of the manufacturing process.
2. Record all critical information, including batch number, date, product details, and equipment used.
3. Document each step of the manufacturing process, including raw material dispensing, mixing, filling, and any other relevant activities.
4. Record actual values and observations, ensuring accuracy and completeness of the information.
5. Include details of any deviations or unexpected events encountered during the manufacturing process.
6. Obtain necessary approvals from designated personnel at key stages of the process.
7. Document in-process quality control checks and test results, including any adjustments made based on these results.
8. Ensure that all required signatures and approvals are obtained for each section of the batch record.
9. Complete the batch record promptly at the conclusion of the manufacturing process.
10. Submit the completed batch record to the quality control department for final review and approval.
11. If any discrepancies or deviations are identified during the review, initiate an investigation and document findings.
12. Archive the approved batch record in the designated record-keeping system in accordance with established retention policies.
13. Ensure that batch records are organized and easily retrievable for regulatory inspections or internal audits.
14. Regularly update and maintain the batch record templates to reflect any process changes or improvements.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Batch Record Templates
• Completed Batch Records
• Deviation and Corrective Action Logs
• Training Records

Reference

ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

SOP Version

Version 1.0