Standard Operating Procedure for Temperature Monitoring in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/027/2025 |
| Supersedes | SOP/GM/027/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 02/06/2025 |
| Effective Date | 04/06/2025 |
| Review Date | 02/06/2026 |
1. Purpose
The purpose of this SOP is to define a consistent approach to monitor and record temperatures during various stages of gel production to ensure that products are processed under controlled conditions as specified in the manufacturing protocol.
2. Scope
This procedure applies to all
temperature-sensitive steps within the Gel Manufacturing Department during the preparation, mixing, addition, and holding of gel formulations.
3. Responsibilities
- Production Chemist: Responsible for monitoring, recording, and maintaining the temperature records.
- Quality Assurance: Review temperature logs and ensure compliance with batch manufacturing instructions.
- Engineering: Ensure temperature monitoring instruments are calibrated and functioning correctly.
4. Accountability
Head – Manufacturing is accountable for ensuring proper temperature monitoring is implemented and followed.
5. Procedure
5.1 Instruments Used
- Digital temperature indicators
- Analog temperature gauges
- Thermocouples or RTDs integrated with SCADA (if applicable)
- Manual log sheets or automated recording systems
5.2 Monitoring Process
- Before initiating production, ensure that all temperature indicators and controllers are calibrated.
- Verify the required temperature ranges from the Batch Manufacturing Record (BMR).
- Monitor temperature:
- During the preparation of the aqueous and non-aqueous phases
- During the addition of polymers, APIs, and preservatives
- During homogenization and deaeration steps
- Record observed temperatures at predefined intervals (e.g., every 15 minutes) or as specified in the BMR.
5.3 Temperature Limits
- Ensure the temperature does not exceed the specified limit for each stage (e.g., polymers added below 40°C, preservatives below 35°C).
- If temperature exceeds limits, immediately inform QA and record the deviation.
5.4 Response to Deviations
- Stop the process if deviation exceeds ±2°C from the limit.
- Label the batch as “Hold” and inform QA.
- Record the deviation and corrective action taken in the deviation register.
5.5 Cleaning and Maintenance
- Clean external probes and sensors after every batch using lint-free cloth and 70% IPA.
- Do not immerse electronic sensors in liquid unless specified by the manufacturer.
6. Abbreviations
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- IPA: Isopropyl Alcohol
- RTD: Resistance Temperature Detector
7. Documents
- Temperature Monitoring Log – Annexure-1
- Deviation Record Sheet – Annexure-2
- Calibration Certificate – Annexure-3
8. References
- ICH Q8 – Pharmaceutical Development
- Schedule M – GMP for Pharmaceuticals
- Internal Calibration and Maintenance SOPs
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Jr. Production Chemist | QA Executive | Head – Manufacturing |
| Department | Gel Manufacturing | Quality Assurance | Manufacturing |
11. Annexures
Annexure-1: Temperature Monitoring Log
Record of temperature at key stages in the process, including time, date, and observations.
Annexure-2: Deviation Record Sheet
Details of any temperature excursions along with corrective actions taken.
Annexure-3: Calibration Certificate
Copy of latest calibration status of digital thermometers or sensors.
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/05/2022 | 1.0 | Initial SOP | New document | QA Head |
| 02/06/2025 | 2.0 | Added response to deviations and maintenance guidelines | Regulatory alignment | QA Head |