APIs) used in the formulation of gel products in the Gel Manufacturing department.

3. Responsibilities

• Production Chemist: To carry out the preparation of the oil phase as per the Batch Manufacturing Record (BMR).
• QA Executive: To verify adherence to instructions and log data.
• Engineering Personnel: To confirm availability and functioning of heating/cooling systems and mixers.

4. Accountability

The Head – Manufacturing is accountable for implementation, compliance, and proper documentation of this procedure within the department.

5. Procedure

5.1 Pre-Preparation Checks

1. Verify cleaning and calibration status of the oil phase vessel.
2. Confirm availability of required raw materials (e.g., oils, emulsifiers, lipophilic drugs) as per BMR.
3. Ensure materials are approved and labeled accordingly.

5.2 Charging of Ingredients

1. Charge the oil-soluble ingredients sequentially into the stainless steel vessel.
2. Use low shear agitation to assist mixing while charging materials.
3. Maintain batch number traceability for each component using Annexure-1 (Oil Phase Log Sheet).

5.3 Heating Process

1. Gradually heat the mixture to the temperature specified in the BMR (typically 60–75°C).
2. Ensure the temperature rise is controlled to prevent degradation of heat-sensitive oils or APIs.
3. Use a calibrated thermometer or integrated temperature sensor to monitor and record temperatures every 5 minutes during heating – record in Annexure-2.

5.4 Mixing

1. Stir the heated solution for a minimum of 30 minutes or as directed in the BMR to ensure complete solubilization and uniformity.
2. Use a variable speed agitator or homogenizer, if required, based on the viscosity of the oil phase.

5.5 Cooling Process

1. Once mixing is complete, initiate gradual cooling using a jacketed vessel or recirculating chiller system.
2. Cool the mixture to the defined temperature (typically 35–40°C) before combining with water or gel base phase.
3. Record cooling temperatures and hold time in Annexure-2.

5.6 Visual and Physical Inspection

1. Conduct visual inspection for uniformity, color, and absence of undissolved particles.
2. If specified, take a sample for clarity and viscosity check before use.

5.7 Transfer for Further Processing

1. Transfer the oil phase to the main manufacturing vessel or holding tank using a sanitized pipeline or transfer pump.
2. Ensure QA verification before initiating next step of manufacturing.

6. Abbreviations

• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient

7. Documents

1. Oil Phase Log Sheet – Annexure-1
2. Temperature Monitoring Record – Annexure-2
3. Batch Manufacturing Record (BMR)

8. References

• Schedule M: Good Manufacturing Practices for Pharmaceuticals
• Internal SOP for Equipment Cleaning and Status Labeling
• USP/NF Monographs for individual ingredients

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Oil Phase Log Sheet

Document component name, batch number, quantity, time of addition, and operator signature.

Annexure-2: Temperature Monitoring Record

Includes hourly temperature readings during heating and cooling stages with timestamp and initials.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/05/2022	1.0	Initial release	Process standardization	QA Head
02/06/2025	2.0	Updated heating & transfer steps	GMP and audit requirements	QA Head