Procedure for Checking Temperature During Manufacturing
| Department | Production/Quality Control (QC)/Engineering |
|---|---|
| SOP No. | SOP/Ointment/072 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the method for monitoring and controlling temperature during the manufacturing process to ensure product consistency, stability, and compliance with GMP standards.
2. Scope
This SOP applies to all personnel in the Production, Quality Control (QC), and Engineering departments responsible for monitoring and verifying temperature conditions during the manufacturing process.
3. Responsibilities
- Production Operator: Monitors and records temperature at specified intervals.
- Production Supervisor: Ensures that manufacturing processes are carried out at the required temperatures.
- Quality Control Analyst: Reviews temperature records and verifies compliance with batch specifications.
- Engineering Team: Maintains and calibrates temperature monitoring devices.
4. Accountability
The Production and Quality Control Managers are accountable for ensuring that temperature monitoring is conducted accurately and documented as per regulatory and GMP standards.
5. Procedure
5.1 Equipment and Materials
- Calibrated digital thermometers
- Temperature sensors (PT100, RTD, or thermocouples)
- Data loggers (if applicable)
- Batch Manufacturing Record (BMR)
- Temperature monitoring logs
- Calibration tools
5.2 Pre-Manufacturing Checks
- Ensure that temperature sensors and thermometers are properly calibrated.
- Verify that heating and cooling systems are functional.
- Confirm that the required temperature settings are defined in the batch manufacturing
record (e.g., 60°C – 75°C for melting phase).
Ensure that materials are at the appropriate starting temperature before processing.
5.3 Monitoring Temperature During Manufacturing
5.3.1 Setting Temperature Conditions
- Set temperature parameters based on the process stage (e.g., heating, cooling, or storage).
- Ensure temperature remains within the defined range during each stage.
- Document any temperature fluctuations and corrective actions taken.
5.3.2 Continuous Temperature Monitoring
- Record temperature at defined intervals (e.g., every 15 minutes).
- Ensure temperature stability is maintained throughout the batch process.
- If temperature deviates from specifications, inform the Production Supervisor immediately.
5.4 Critical Temperature Control Points
- Melting Stage: Maintain temperature to ensure complete dissolution of waxes and emulsifiers.
- Mixing Stage: Ensure temperature is optimal for uniform blending.
- Cooling Phase: Control cooling rate to prevent crystallization or phase separation.
5.5 Temperature Adjustment Guidelines
- If temperature drops below the lower limit, increase heating cautiously.
- If temperature exceeds the upper limit, reduce heating or initiate cooling.
- Ensure slow and controlled temperature changes to prevent formulation instability.
5.6 Post-Manufacturing Verification
- Check final product temperature before storage or packaging.
- Verify batch temperature records against defined specifications.
- Ensure all deviations and corrective actions are documented.
5.7 Documentation
- Record all temperature readings in the Temperature Monitoring Log.
- Document corrective actions taken in case of deviations.
- QA personnel must review and approve the log before batch release.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- RTD – Resistance Temperature Detector
- BMR – Batch Manufacturing Record
7. Documents
- Temperature Monitoring Log (Annexure-1)
- Batch Manufacturing Record (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- ICH Q8 – Pharmaceutical Development
- USP <1118> – Monitoring Devices – Time, Temperature, and Humidity
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Temperature Monitoring Log
| Date | Batch Number | Time | Process Stage | Set Temperature (°C) | Observed Temperature (°C) | Result | Verified By |
|---|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | 10:00 AM | Melting | 70°C | 70.2°C | Pass | QA Officer |
| 01/02/2025 | OINT-101 | 10:30 AM | Cooling | 40°C | 39.8°C | Pass | QA Officer |
Annexure-2: Batch Manufacturing Record
| Date | Batch Number | Process Stage | Target Temperature (°C) | Actual Temperature (°C) | Final Status | Approved By |
|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Primary Mixing | 65°C | 64.9°C | Approved | QA Head |
| 01/02/2025 | OINT-101 | Final Cooling | 30°C | 30.1°C | Approved | QA Head |