Standard Operating Procedure for Batch Record Preparation and Documentation

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the proper preparation and documentation of batch records in the pharmaceutical manufacturing process. This SOP ensures that batch records are accurately and comprehensively documented, reflecting all critical steps, measurements, and observations during the production of pharmaceutical products.

2. Scope

This SOP applies to all personnel involved in the batch record preparation and documentation process, including production operators, quality control personnel, and quality assurance staff.

3. Responsibilities

• Production Operators: Responsible for recording all information and data during the production process accurately and legibly in the batch record.
• Quality Control (QC) Personnel: Responsible for reviewing and verifying the accuracy and completeness of the recorded data in the batch record.
• Quality Assurance (QA) Staff: Responsible for approving and maintaining the batch records and ensuring compliance with this SOP.
• Production Supervisor: Responsible for overseeing the batch record preparation process and addressing any deviations or issues.

4. Procedure

4.1 Batch Record Format:

• Use a standardized batch record format that includes clear headings, spaces for data entry, and sequential numbering for easy tracking.
• Include the product name, batch number, manufacturing date, and other essential details at the beginning of the batch record.
• Ensure that the batch record format complies with regulatory requirements and internal quality standards.

4.2 Recording of Data:

• Record all critical steps, measurements, calculations, and observations during the production process in real-time.
• Use clear and legible handwriting when documenting data in the batch record.
• Include specific details such as equipment used, batch size, processing times, and any deviations encountered with explanations.
• Review data entries for accuracy and completeness before finalizing the batch record.

4.3 Review and Verification:

• QC personnel should review the batch record for completeness, accuracy, and compliance with standard procedures.
• Verify that all required signatures, approvals, and dates are present in the batch record.
• Document any discrepancies or deviations found during the review process and take appropriate corrective actions.

4.4 Batch Record Approval:

• Submit the completed batch record to the QA department for final review and approval.
• QA staff should ensure that the batch record is complete, accurate, and in compliance with regulatory requirements.
• Once approved, maintain the batch record securely as a part of the batch documentation.

4.5 Batch Record Retention:

• Maintain the batch records in a controlled and organized manner.
• Follow the company’s record retention policy and regulatory requirements for the storage and retention of batch records.
• Store the batch records in a secure and easily retrievable location for a defined period as per company policy.

5. Abbreviations

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

6. Documents

The following documents are relevant to this SOP:

• Standard Batch Record Format
• Batch Record Review and Approval Form
• Batch Record Retention and Archiving Policy

7. References

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

8. SOP Version

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