Standard Operating Procedure for Alarms and Alerts Handling During Culture in Biosimilar Manufacturing
| Department | Biosimilars |
|---|---|
| SOP No. | SOP/BS/149/2025 |
| Supersedes | SOP/BS/149/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 04/05/2025 |
| Effective Date | 06/05/2025 |
| Review Date | 04/05/2026 |
1. Purpose
To define a standardized approach for handling, investigating, and documenting alarms and alerts generated during culture operations in biosimilar upstream processing. This ensures process continuity, product quality, and GMP compliance.
2. Scope
This SOP applies to all automated bioreactor systems, incubators, culture monitoring systems, and support utilities generating audio/visual or software-based alarms during biosimilar manufacturing.
3. Responsibilities
- Production Operators: Monitor alarms and alerts, take immediate action as per instructions, and document the event.
- Engineering: Investigate equipment-related faults and restore functionality.
- QA: Review alarm incidents and approve CAPA if critical deviations are involved.
4. Accountability
The Head of Manufacturing is accountable for ensuring alarm handling procedures are followed, documented, and reviewed for compliance and process robustness.
5. Procedure
5.1 Types of Alarms and Alerts
- Process Alarms: Deviations in setpoint parameters like temperature, pH, DO, agitation speed.
- Equipment Alarms: Malfunctions such as motor failure, pump stoppage, sensor disconnection.
- System Alerts: Communication errors, power backup switching, minor warnings not affecting critical control.
5.2 Alarm Detection and Initial Response
- All alarms shall trigger a visual or audible indicator and log entry in SCADA/BMS/PLC system.
- Operators must acknowledge the alarm within 2 minutes.
- Review the alarm message, timestamp, and parameter deviation details.
5.3 Immediate Actions
- If within alert range: monitor closely, inform supervisor, and continue process.
- If alarm is critical:
- Pause process if required.
- Isolate the affected system.
- Initiate corrective action such as resetting the controller or switching to backup equipment.
- Log the alarm in Annexure-1: Alarm Handling Log and inform QA if it may impact batch quality.
5.4 Investigation and Documentation
- Engineering to perform system diagnostics and identify root cause.
- QA to initiate deviation if alarm led to parameter excursion or batch impact.
- Attach alarm printout and controller logs to Annexure-2: Alarm Investigation Form.
5.5 Closure and Review
- After resolution, reset system and resume operations as per QA approval.
- QA to trend alarms monthly and assess reoccurrence for system improvements.
6. Abbreviations
- SCADA: Supervisory Control and Data Acquisition
- QA: Quality Assurance
- PLC: Programmable Logic Controller
- BMS: Building Management System
7. Documents
- Alarm Handling Log – Annexure-1
- Alarm Investigation Form – Annexure-2
8. References
- ICH Q10 – Pharmaceutical Quality System
- EU GMP Annex 11 – Computerized Systems
- FDA CFR Part 211 – Subpart D: Equipment
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Alarm Handling Log
| Date | System | Parameter | Alarm Type | Action Taken | Operator |
|---|---|---|---|---|---|
| 03/05/2025 | Bioreactor-5 | DO | High Alarm | Reduced airflow | Ajay Verma |
Annexure-2: Alarm Investigation Form
| Alarm ID | Date | Description | Root Cause | Corrective Action | QA Review |
|---|---|---|---|---|---|
| AL-DO-037 | 03/05/2025 | DO spike > 85% | Flow valve stuck open | Replaced actuator | Reviewed |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 04/05/2025 | 2.0 | Expanded alarm classification and added SCADA integration steps | System enhancement |