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