Standard Operating Procedure for Monitoring and Logging of Critical Parameters in Biosimilar Manufacturing
| Department | Biosimilars |
|---|---|
| SOP No. | SOP/BS/101/2025 |
| Supersedes | SOP/BS/101/2022 |
| 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 real-time monitoring and accurate documentation of critical process parameters during biosimilar bioreactor operations, ensuring data integrity and adherence to GMP requirements.
2. Scope
This SOP applies to all small-scale, pilot, and production bioreactor systems used in upstream processing of biosimilars, covering both single-use and stainless-steel systems.
3. Responsibilities
- Production Operator: Monitor and record critical parameters as per defined frequency in the BMR.
- Shift Supervisor: Review logs and intervene if critical limits are approached.
- QA: Verify records and monitor for any deviations or missed entries.
4. Accountability
The Head of Manufacturing is accountable for ensuring that all critical process parameters are monitored and recorded systematically during biosimilar production.
5. Procedure
5.1 Definition of Critical Parameters
- Identify and monitor the following as critical parameters:
- Temperature
- pH
- Dissolved Oxygen (DO)
- Agitation Speed
- Vessel Pressure
- Foam Level
5.2 Monitoring Frequency and Systems
- Real-time data must be collected via SCADA/DCS (e.g., DeltaV, Siemens PCS7).
- Manual cross-verification must be done every 4 hours for each parameter.
- Record readings in Annexure-1: Critical Parameter Log Sheet.
5.3 Alarm Handling
- In case of deviation from target range, alarms will trigger in control panel.
- Operators must acknowledge alarms and take corrective action per deviation SOP.
- Document all alarms and actions in Annexure-2.
5.4 Data Integrity and Logging
- Ensure entries are:
- Legible
- Initialed with date/time
- Free from overwriting or erasure
- Maintain logs for a minimum of 5 years in the controlled archive room.
5.5 Trend Review and Reporting
- Generate trend charts weekly and review for any process drift.
- Report abnormalities or excursions to QA within 24 hours.
6. Abbreviations
- DO: Dissolved Oxygen
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- SCADA: Supervisory Control and Data Acquisition
7. Documents
- Critical Parameter Log Sheet – Annexure-1
- Alarm Acknowledgment & Response Record – Annexure-2
8. References
- ICH Q10 – Pharmaceutical Quality System
- 21 CFR Part 11 – Electronic Records and Signatures
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Critical Parameter Log Sheet
| Date | Time | Temp (°C) | pH | DO (%) | Agitation (rpm) | Foam | Initials |
|---|---|---|---|---|---|---|---|
| 04/05/2025 | 08:00 | 36.9 | 7.2 | 45 | 150 | Low | SR |
Annexure-2: Alarm Acknowledgment & Response Record
| Date | Time | Parameter | Alarm Type | Action Taken | By Whom |
|---|---|---|---|---|---|
| 04/05/2025 | 10:20 | DO | Low DO | Increased airflow rate | Rajesh Kumar |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 04/05/2025 | 2.0 | Added alarm handling section and electronic logging compliance | Regulatory update |