Standard Operating Procedure for Electronic Batch Record (EBR) Entry in Biosimilar Upstream Manufacturing
| Department | Biosimilars |
|---|---|
| SOP No. | SOP/BS/103/2025 |
| Supersedes | SOP/BS/103/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 04/05/2025 |
| Effective Date | 06/05/2025 |
| Review Date | 04/05/2026 |
1. Purpose
To define the procedure for accurate, timely, and compliant entry of manufacturing process data into the Electronic Batch Record (EBR) system during upstream biosimilar production, in alignment with data integrity and GMP principles.
2. Scope
This SOP applies to all upstream operations including media preparation, inoculation, seed train expansion, bioreactor runs, and harvest activities where electronic records are maintained within the biosimilars manufacturing department.
3. Responsibilities
- Production Operator: Enter data into the EBR system in real-time and ensure completeness.
- Production Supervisor: Review and verify EBR entries at defined checkpoints.
- QA: Audit and approve final EBRs before batch disposition.
4. Accountability
The Manufacturing Head is accountable for ensuring that electronic batch records are complete, traceable, and comply with 21 CFR Part 11 requirements.
5. Procedure
5.1 Access Control
- All personnel must have unique login credentials issued by the IT Administrator.
- Access is role-based and logged with time stamps in audit trails.
- Do not share login information or use generic credentials.
5.2 Real-Time Data Entry
- Enter all process values (temperature, pH, DO, agitation, pressure) as they occur or within 15 minutes of execution.
- For automated entries (from SCADA), verify synchronization and correctness daily.
- Manual entries must include operator initials and entry date/time.
5.3 Data Verification and Review
- Supervisor shall verify each section for:
- Completeness
- Legibility
- Proper units
- Timestamp consistency
- Mark reviewed sections as “Verified” with supervisor’s electronic signature.
5.4 Deviation Documentation
- In case of discrepancy or deviation, raise a deviation record from within the EBR interface and cross-reference deviation number.
- Link associated CAPA documentation as required.
5.5 Batch Record Lock and Submission
- Upon completion of upstream activities:
- Lock the EBR to prevent further editing.
- Submit for QA review via the workflow engine.
5.6 Backup and Data Integrity
- All EBR data must be backed up daily to secure, validated servers.
- Data must be retained for a minimum of 7 years.
6. Abbreviations
- EBR: Electronic Batch Record
- SCADA: Supervisory Control and Data Acquisition
- CAPA: Corrective and Preventive Action
- QA: Quality Assurance
7. Documents
- EBR Daily Entry Log – Annexure-1
- EBR Deviation Summary – Annexure-2
8. References
- 21 CFR Part 11 – Electronic Records and Signatures
- WHO TRS 996 – GMP for Electronic Documentation
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: EBR Daily Entry Log
| Date | Parameter | Value | Entered By | Verified By |
|---|---|---|---|---|
| 04/05/2025 | pH | 7.1 | Sunita Reddy | Ajay Verma |
Annexure-2: EBR Deviation Summary
| Deviation ID | Date | Description | Link to CAPA | Status |
|---|---|---|---|---|
| EBR-DEV-014 | 04/05/2025 | Omitted DO reading at 10:00 | CAPA-105 | Closed |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 04/05/2025 | 2.0 | Included audit trail and backup retention procedures | Regulatory compliance update |