Standard Operating Procedure for Monitoring Temperature during Sterile Filling
| Department | Sterile Injectable Manufacturing |
|---|---|
| SOP No. | SOP/SIM/071/2025 |
| Supersedes | SOP/SIM/071/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 18/06/2025 |
| Effective Date | 20/06/2025 |
| Review Date | 18/06/2026 |
1. Purpose
This SOP defines the procedure for real-time monitoring and control of temperature conditions during the sterile filling process to maintain product integrity and meet GMP compliance.
2. Scope
This SOP applies to all sterile filling activities conducted under laminar airflow conditions within aseptic manufacturing
areas for injectable products.
3. Responsibilities
- Production Operator: Monitors and records temperature at defined intervals.
- Engineering Personnel: Calibrates and maintains temperature monitoring instruments.
- QA Officer: Verifies temperature records and ensures SOP adherence.
4. Accountability
The Head of Production is accountable for the implementation and compliance with this SOP.
5. Procedure
5.1 Preparation Before Filling
- Ensure all temperature monitoring devices (digital sensors, thermocouples, etc.) are calibrated and installed at strategic points in the filling line.
- Verify calibration certificates before initiating filling (Annexure-1: Calibration Verification Log).
5.2 Temperature Monitoring During Filling
- Monitor and record temperature every 30 minutes during the sterile filling activity.
- Ensure filling is conducted within validated temperature ranges (e.g., 18°C–25°C).
- Use automated systems with data logging where available; in absence, use manual temperature log sheets (Annexure-2).
- In case of deviation from the acceptable range, immediately:
- Stop the filling operation.
- Inform QA and Engineering.
- Initiate deviation report and root cause analysis (Annexure-3).
5.3 Post-Operation Review
- QA shall review temperature logs post batch completion.
- Logs shall be archived as part of batch manufacturing records (minimum retention: 5 years).
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- °C: Degrees Celsius
7. Documents
- Calibration Verification Log – Annexure-1
- Temperature Monitoring Log Sheet – Annexure-2
- Temperature Deviation Report – Annexure-3
8. References
- WHO Technical Report Series 961, Annex 6
- EU GMP Annex 1: Manufacture of Sterile Medicinal Products
- ICH Q9: Quality Risk Management
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Manufacturing Executive | QA Executive | Head QA |
| Department | Production | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: Calibration Verification Log
| Device ID | Location | Calibration Due | Verified By |
|---|---|---|---|
| TS-104 | Filling Zone A | 30/06/2025 | Sunita Reddy |
Annexure-2: Temperature Monitoring Log Sheet
| Date | Time | Temperature (°C) | Recorded By | Remarks |
|---|---|---|---|---|
| 18/06/2025 | 09:00 AM | 22.3 | Rajesh Kumar | Within range |
Annexure-3: Temperature Deviation Report
| Date | Deviation Observed | Corrective Action | Root Cause | Reviewed By |
|---|---|---|---|---|
| 18/06/2025 | 27.5°C | Filling stopped, HVAC adjusted | AHU malfunction | Anita Desai |
Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Issue | New SOP | QA Head |
| 18/06/2025 | 2.0 | Updated temperature recording and annexures | Periodic Review | QA Head |