Procedure for Temperature Monitoring in Manufacturing
| Department | Production/Quality Assurance (QA)/Engineering |
|---|---|
| SOP No. | SOP/Ointment/037 |
| 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 a standardized process for monitoring and controlling temperature during the manufacturing of ointments. Proper temperature regulation ensures product consistency, prevents degradation, and maintains compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all temperature-sensitive operations in ointment manufacturing, including ingredient pre-heating, mixing, emulsification, cooling, and storage.
3. Responsibilities
- Production Supervisor: Ensures adherence to temperature control guidelines.
- Machine Operator: Monitors and records temperature readings at defined intervals.
- Quality Assurance (QA) Personnel: Verifies compliance with GMP and regulatory standards.
- Engineering Technician: Maintains and calibrates temperature monitoring devices.
4. Accountability
The Production and QA Managers are accountable for ensuring that temperature monitoring is conducted as per GMP guidelines and properly documented.
5. Procedure
5.1 Pre-Production Temperature Checks
- Verify calibration status of all temperature monitoring devices (e.g., thermocouples, infrared sensors).
- Ensure heating and cooling systems are operational before starting production.
- Confirm that the processing vessels and storage tanks are within the specified temperature range.
5.2 Temperature Monitoring at Different Manufacturing Stages
5.2.1 Ingredient Pre-Heating
- Ensure waxes, oils, and emulsifiers are heated within the required range (e.g.,
60°C–80°C).
Prevent overheating, which may degrade sensitive ingredients.
Record temperature readings every 15 minutes.
5.2.2 Mixing and Emulsification
- Maintain the temperature range as specified in the Batch Manufacturing Record (BMR).
- Monitor and document temperature fluctuations during emulsification.
- Ensure that temperature does not exceed stability limits.
5.2.3 Cooling and Solidification
- Gradually lower temperature to prevent crystallization.
- Monitor and document cooling rate to ensure controlled solidification.
- Ensure final batch temperature matches product specifications.
5.2.4 Storage and Holding
- Verify that ointments are stored at the prescribed temperature (e.g., 15°C–25°C).
- Check storage temperature at least twice per shift.
- Ensure refrigerated storage units (if applicable) are functioning properly.
5.3 Handling Temperature Deviations
- If temperature exceeds limits, immediately stop the process and inform QA.
- Identify the cause of deviation (e.g., equipment failure, power fluctuations).
- Implement corrective and preventive actions (CAPA) and document in the Temperature Deviation Log.
5.4 Documentation and Approval
- Record all temperature readings in the Temperature Monitoring Log.
- QA must review and approve temperature data before batch release.
- Maintain records for regulatory inspections and audits.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
- CAPA – Corrective and Preventive Action
7. Documents
- Temperature Monitoring Log (Annexure-1)
- Temperature Deviation Log (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
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 | Stage | Temperature (°C) | Time of Reading | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | Pre-Heating | 65°C | 10:00 AM | QA Officer |
| 01/02/2025 | SOP/Ointment/001 | Final Mixing | 42°C | 12:30 PM | QA Officer |
Annexure-2: Temperature Deviation Log
| Date | Batch Number | Stage | Deviation | Corrective Action | Approved By |
|---|---|---|---|---|---|
| 02/02/2025 | SOP/Ointment/002 | Cooling | Temperature dropped below 30°C | Increased mixing speed | QA Head |
| 03/02/2025 | SOP/Ointment/003 | Final Mixing | Temperature exceeded 50°C | Adjusted heating rate | QA Head |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |