Procedure for Adding Emulsifiers to the Mixture

Department	Production/Quality Assurance (QA)/Research and Development (R&D)
SOP No.	SOP/Ointment/032
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 establish a standardized method for adding emulsifiers to the ointment mixture. Proper emulsification ensures stability, uniformity, and homogeneity of the final product.

2. Scope

This SOP applies to all personnel involved in the preparation and emulsification of ointments in the manufacturing process.

3. Responsibilities

• Production Supervisor: Ensures emulsifiers are added as per the formulation.
• Machine Operator: Controls mixing speed, temperature, and timing during emulsification.
• Quality Assurance (QA) Personnel: Monitors emulsifier addition for compliance with GMP standards.
• R&D Scientist: Defines emulsification parameters for different formulations.

4. Accountability

The Production and QA Managers are accountable for ensuring that emulsifier addition is performed as per GMP standards and documented correctly.

5. Procedure

5.1 Pre-Addition Preparations

• Ensure that all emulsifiers are weighed and verified against the Batch Manufacturing Record (BMR).
• Check that the heating vessel is clean and pre-heated to the required temperature.
• Confirm that temperature probes and mixing systems are operational.

5.2 Adding Emulsifiers

• Slowly introduce emulsifiers into the heated base material.
• Ensure emulsifiers are dispersed evenly to avoid agglomeration.
• Increase mixing speed to promote uniform emulsification.

5.3 Mixing Parameters

• Maintain the mixing speed as per the formulation specifications.
• Monitor temperature throughout the emulsification process.
• Continue mixing for the time specified in the batch record.

5.4 Monitoring During Addition

• Check for uniform dispersion of emulsifiers.
• Ensure no foaming or phase separation occurs.
• Record all process parameters in the Emulsification Log.

5.5 Completion of Emulsification

• Confirm that the emulsification process is complete and homogeneous.
• Hold the mixture at the final temperature before cooling.
• Record final temperature, mixing speed, and duration.

5.6 Documentation and Approval

• Record emulsifier addition parameters in the Mixing Log.
• QA must verify and approve emulsified mixture before further processing.
• Label the batch as “Emulsified and Ready for Cooling.”

6. Abbreviations

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

7. Documents

• Emulsification 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: Emulsification Log

Date	Batch Number	Emulsifier Name	Temperature (°C)	Mixing Speed (RPM)	Time (Min)	Verified By
01/02/2025	SOP/Ointment/001	Polysorbate 80	65°C	800	30	QA Officer
02/02/2025	SOP/Ointment/002	Cetyl Alcohol	70°C	1000	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	Polysorbate 80	20°C	65°C	QA Head
02/02/2025	SOP/Ointment/002	Cetyl Alcohol	22°C	70°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