SOP Guide for Pharma

Ointments: SOP for Heating Ointment Bases to Target Temperatures – V 2.0

SOP for Heating Ointment Bases to Target Temperatures – V 2.0

Procedure for Heating Ointment Bases to Target Temperatures

Department Manufacturing/Production/Quality Assurance (QA)/Quality Control (QC)/Research and Development (R&D)
SOP No. SOP/Ointment/191
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 systematic approach for heating ointment bases to target temperatures to ensure optimal consistency, homogeneity, and stability. Proper temperature control is essential for the dissolution of active ingredients, excipients, and emulsifiers.

2. Scope

This SOP applies to all personnel involved in the preparation, heating, and quality control of ointment bases in the Manufacturing, Production, Quality Assurance (QA), Quality Control (QC), and Research and Development (R&D) departments.

3. Responsibilities

4. Accountability

The Production Manager is accountable for ensuring that all heating procedures comply with GMP, FDA, ICH, WHO, and company policies.

5. Procedure

5.1 Pre-Heating Preparation

5.2 Setting Up the Heating Equipment

5.3 Heating Process

5.4 Temperature Monitoring and Quality Control

5.5 Cooling and Post-Heating Handling

5.6 Equipment Cleaning and Shutdown

6. Abbreviations

7. Documents

8. References

9. SOP Version

Version 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Pre-Heating Checklist

Date Batch No. Ingredient Availability QA Approval
02/02/2025 OINT-1002 Complete Approved

Annexure-2: Equipment Setup Log

Date Equipment Name Calibration Status QA Approval
02/02/2025 Steam-Jacketed Kettle Validated Approved

12. Revision History

Revision Date Revision No. Details Reason Approved By
02/02/2025 2.0 Expanded Heating Parameters Regulatory Compliance QA Head
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