Elixir Department: SOP for Electronic Batch Record Systems – V 2.0

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Elixir Department: SOP for Electronic Batch Record Systems – V 2.0

Standard Operating Procedure for Electronic Batch Record Systems in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/151/2025
Supersedes SOP/ELX/151/2022
Page No. Page 1 of 10
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To establish a standardized procedure for the creation, use, review, and archival of Electronic Batch Records (EBRs) used in the elixir manufacturing process to ensure data integrity, compliance, traceability, and efficiency in documentation.

2. Scope

This SOP is applicable to all personnel involved in creating, entering, reviewing, and approving batch records electronically within the Elixir Department, including the integration of data from automated systems (SCADA, LIMS, MES).

3. Responsibilities

  • Production Operator:
    • Enter batch-wise processing data promptly and accurately.
    • Ensure timely confirmation of each manufacturing step in the EBR system.
  • Production Supervisor:
    • Review data entries, sign off digitally, and ensure correctness.
  • QA Officer:
    • Perform batch record verification and final approval in the EBR system.
  • IT/Admin:
    • Ensure system availability, user access controls, and backup of EBR data.
See also  Elixir Department: SOP for Cold Storage Transfer of Heat-Sensitive Batches - V 2.0

4. Accountability

The Production Head is accountable for implementation and use. The QA Head ensures compliance and review. The IT

Head maintains system integrity and audit trails.

5. Procedure

5.1 Access Control and Login

  1. Each user must have a unique user ID and password assigned by the IT Administrator.
  2. Roles are assigned based on job function (e.g., Entry, Review, Approval).
  3. Passwords must not be shared and should be changed every 30 days.

5.2 Batch Record Creation

  1. QA or authorized production staff generates a new batch template based on the MFR.
  2. System auto-generates a unique Batch No. linked with the date and product code.
  3. All required fields such as raw material lot numbers, equipment ID, and operator details are populated from integrated modules or entered manually.

5.3 Data Entry and Real-Time Logging

  1. Production operators shall log in to the EBR system during manufacturing and enter:
    • Start and end time of each step
    • Temperature, RPM, pH, and volume
    • Observations, deviations, and corrective actions
  2. Data entries must be saved immediately after completion of each step.
See also  Elixir Department: SOP for Handling Material Return Post Dispensing - V 2.0

5.4 Review and Approval Workflow

  1. Production Supervisor shall digitally review each section for completeness and correctness.
  2. QA shall review the final batch record for compliance and give digital approval.
  3. Once approved, the batch record status is changed to “Released” and archived automatically.

5.5 Deviation and Audit Trail

  1. If any entry needs correction after submission, it shall follow electronic deviation management workflow.
  2. All changes are logged with timestamp, user ID, and reason for change (21 CFR Part 11 compliant).
  3. Audit trails are reviewed monthly by QA and IT.

5.6 Backup and Data Retention

  1. Automated backups of EBRs must occur daily to secure offsite and onsite servers.
  2. Data shall be retained for a minimum of 5 years or as per regulatory requirements.
See also  Elixir Department: SOP for Preventive Maintenance of Filling Machines - V 2.0

6. Abbreviations

  • EBR: Electronic Batch Record
  • QA: Quality Assurance
  • IT: Information Technology
  • SCADA: Supervisory Control and Data Acquisition
  • LIMS: Laboratory Information Management System
  • MES: Manufacturing Execution System

7. Documents

  1. Electronic Batch Record (system-based)
  2. Audit Trail Reports
  3. Deviation Logs (if applicable)

8. References

  • 21 CFR Part 11 – Electronic Records and Electronic Signatures
  • EU GMP Annex 11 – Computerised Systems
  • WHO TRS 1019 – Data Integrity in Electronic Systems

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

All records are maintained within the validated EBR system. No physical annexures apply.

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Release New System Implementation QA Head
11/04/2025 2.0 Added LIMS/MES Integration and Audit Trail Compliance Enhancement QA Head
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