Procedure for Final Mixing Stage in Ointment Manufacturing

Department	Production/Quality Assurance (QA)/Research and Development (R&D)
SOP No.	SOP/Ointment/034
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 process for the final mixing stage in ointment manufacturing. This stage ensures homogeneity, proper dispersion of active ingredients, and overall product consistency.

2. Scope

This SOP applies to all personnel involved in the final mixing stage of ointment production in the manufacturing area.

3. Responsibilities

• Production Supervisor: Ensures adherence to the final mixing parameters.
• Machine Operator: Controls mixing speed, temperature, and duration.
• Quality Assurance (QA) Personnel: Verifies homogeneity and compliance with GMP standards.
• R&D Scientist: Provides formulation specifications and process validation.

4. Accountability

The Production and QA Managers are accountable for ensuring that the final mixing stage is conducted as per GMP standards and properly documented.

5. Procedure

5.1 Pre-Mixing Preparations

• Ensure that the cooling process has been completed.
• Verify the equipment’s cleanliness and calibration status.
• Check that the batch meets the required temperature for final mixing (e.g., 35°C-45°C).

5.2 Initiation of Final Mixing

• Start the mixer at a slow speed to avoid air entrapment.
• Gradually increase the mixing speed to ensure uniform dispersion.
• Maintain the required mixing time as per the Batch Manufacturing Record (BMR).

5.3 Monitoring During Mixing

• Check for uniformity in texture and viscosity.
• Ensure no air bubbles are trapped in the ointment.
• Monitor temperature and adjust mixing parameters if needed.

5.4 Completion of Mixing

• Reduce mixing speed gradually to prevent phase separation.
• Confirm complete homogenization and uniform distribution of active ingredients.
• Conduct an in-process quality check before batch approval.

5.5 Documentation and Approval

• Record all process parameters in the Final Mixing Log.
• QA must verify and approve the batch before transferring for filling.
• Label the batch as “Final Mixed and Ready for Filling.”

6. Abbreviations

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

7. Documents

• Final Mixing Log (Annexure-1)
• In-Process Quality Check 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: Final Mixing Log

Date	Batch Number	Mixing Speed (RPM)	Temperature (°C)	Mixing Time (Min)	Verified By
01/02/2025	SOP/Ointment/001	500	40°C	20	QA Officer
02/02/2025	SOP/Ointment/002	600	38°C	25	QA Officer

Annexure-2: In-Process Quality Check Report

Date	Batch Number	Test Parameter	Specification	Result	Final Status
01/02/2025	SOP/Ointment/001	Viscosity	1000-2000 cP	1500 cP	Pass
02/02/2025	SOP/Ointment/002	pH	5.5-7.0	6.2	Pass

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