Standard Operating Procedure for Electronic Control System Backup and Restoration in Biosimilar Manufacturing

Department	Biosimilars
SOP No.	SOP/BS/122/2025
Supersedes	SOP/BS/122/2022
Page No.	Page 1 of 11
Issue Date	04/05/2025
Effective Date	06/05/2025
Review Date	04/05/2026

1. Purpose

To define the procedure for systematic backup and restoration of electronic control systems used in upstream biosimilar manufacturing to ensure data integrity, continuity, and GMP compliance.

2. Scope

This SOP applies to electronic systems managing bioreactors, SCADA platforms, HMI panels, PLC controllers, and environmental monitoring systems in the upstream production area.

3. Responsibilities

• IT/Automation Engineer: Perform scheduled backups, verify restoration procedures, and maintain backup logs.
• Production: Ensure system availability during backups and notify of planned activities.
• QA: Review backup records and approve deviations in case of restoration.

4. Accountability

The Head of IT/Automation is accountable for ensuring secure and validated backup/restore operations across all relevant electronic control systems.

5. Procedure

5.1 Backup Strategy and Frequency

1. Classify backups as:
   • Daily Incremental Backups: For log files and batch data
   • Weekly Full Backups: For system configurations and historical archives
   • Monthly Archive: For offsite storage
2. Automate backups using control system’s inbuilt scheduler or third-party software.

5.2 Backup Process

1. Ensure system is in idle or maintenance mode before full backup.
2. Connect secured external drive or access network backup directory.
3. Export:
   • Batch data (.CSV, .XML)
   • System configuration files (.INI, .CFG)
   • Recipe and control logic (PLC, SCADA scripts)
4. Encrypt and store with unique backup ID and date label.
5. Update Annexure-1: Backup Log Sheet.

5.3 Backup Verification

1. Perform test restoration once per quarter to validate backup integrity.
2. Simulate recovery on sandbox/test system; verify access, control parameters, and batch retrieval.
3. Record verification outcome in Annexure-2: Restoration Test Log.

5.4 Restoration Procedure

1. Initiate restoration only upon system failure, corruption, or hardware replacement.
2. Ensure QA approval before proceeding with recovery.
3. Restore from the most recent validated backup using authorized personnel only.
4. Perform functionality check post-restoration and document in Annexure-3.

5.5 Data Security and Retention

1. Store backups in dual locations:
   • Primary: Network Attached Storage (NAS)
   • Secondary: Encrypted External Hard Disk (offsite)
2. Retain backup logs for minimum of 5 years.

6. Abbreviations

• SCADA: Supervisory Control and Data Acquisition
• PLC: Programmable Logic Controller
• HMI: Human Machine Interface
• NAS: Network Attached Storage

7. Documents

1. Backup Log Sheet – Annexure-1
2. Restoration Test Log – Annexure-2
3. Restoration Execution Record – Annexure-3

8. References

• 21 CFR Part 11 – Electronic Records and Signatures
• ICH Q9 – Quality Risk Management
• EU GMP Annex 11 – Computerised Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Backup Log Sheet

Date	Type	Backup ID	Performed By	Storage Location
04/05/2025	Weekly Full	BKUP-SCADA-0925	Ajay Verma	NAS/External HDD

Annexure-2: Restoration Test Log

Date	System	Backup ID	Result	Verified By
01/04/2025	BR-200L SCADA	BKUP-SCADA-0325	Successful	Sunita Reddy

Annexure-3: Restoration Execution Record

Date	System	Reason	Backup ID	Restored By	QA Approval
04/05/2025	BR-100L	PLC Crash	BKUP-APRIL	Vinay Pawar	Yes

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Expanded to include encryption and verification testing process	System upgrade