Procedure for Initial Heating Stage in Ointment Manufacturing

Department	Production/Quality Assurance (QA)/Engineering
SOP No.	SOP/Ointment/031
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 systematic approach for the initial heating stage in ointment manufacturing. Proper heating ensures uniform melting of base materials, enhances ingredient solubility, and maintains product consistency.

2. Scope

This SOP applies to all personnel responsible for the heating of waxes, oils, emulsifiers, and other base materials in the ointment manufacturing process.

3. Responsibilities

• Production Supervisor: Ensures adherence to heating parameters and safety protocols.
• Machine Operator: Monitors temperature, heating duration, and mixing conditions.
• QA Personnel: Verifies temperature accuracy and compliance with GMP requirements.
• Engineering Technician: Ensures heating system functionality and calibration.

4. Accountability

The Production and QA Managers are accountable for ensuring that the initial heating stage is performed as per GMP and documented correctly.

5. Procedure

5.1 Pre-Heating Preparations

• Ensure the heating vessel is clean and dry.
• Check the availability of required base materials as per the Batch Manufacturing Record (BMR).
• Verify the calibration status of temperature sensors.

5.2 Loading of Base Materials

• Weigh and transfer waxes, oils, and emulsifiers into the heating vessel.
• Use a slow agitation setting to ensure uniform heat distribution.
• Ensure no contamination occurs during material transfer.

5.3 Heating Process

• Gradually increase the temperature to the specified range (e.g., 60°C–80°C).
• Monitor heating rate to prevent thermal degradation.
• Ensure constant stirring to maintain homogeneity.

5.4 Monitoring During Heating

• Check temperature at regular intervals using a calibrated thermometer.
• Observe for uniform melting without residue formation.
• Ensure no overheating or burning occurs.

5.5 Completion of Heating Stage

• Confirm complete melting of all ingredients.
• Hold the mixture at the final heating temperature for the required duration.
• Record final temperature and time before proceeding to emulsification.

5.6 Documentation and Approval

• Record heating parameters in the Heating Log.
• QA must verify and approve the batch before further processing.
• Label the batch as “Melted and Ready for Mixing.”

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BMR – Batch Manufacturing Record

7. Documents

• Heating Log (Annexure-1)
• Temperature Monitoring Report (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• 21 CFR Part 211 – Current Good Manufacturing Practices
• Equipment Manufacturer Guidelines

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Heating Log

Date	Batch Number	Material Name	Heating Temperature (°C)	Time (Min)	Verified By
01/02/2025	SOP/Ointment/001	White Petrolatum	70°C	30	QA Officer
02/02/2025	SOP/Ointment/002	Beeswax	75°C	40	QA Officer

Annexure-2: Temperature Monitoring Report

Date	Batch Number	Material Name	Initial Temp (°C)	Final Temp (°C)	Approved By
01/02/2025	SOP/Ointment/001	White Petrolatum	20°C	70°C	QA Head
02/02/2025	SOP/Ointment/002	Beeswax	22°C	75°C	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