the incorporation of active pharmaceutical ingredients (APIs).

2. Scope

This SOP applies to all gel base preparations carried out in the Gel Manufacturing Department of the pharmaceutical formulation facility.

3. Responsibilities

• Production Operator: Responsible for executing the gel base preparation as per SOP.
• Production Supervisor: Ensure availability of raw materials and review the process adherence.
• Quality Assurance: Verify the preparation process and review in-process checks and documentation.

4. Accountability

The Head of Manufacturing is accountable for the proper implementation of this SOP. The Quality Assurance Head is responsible for ensuring compliance and documentation control.

5. Procedure

5.1 Preparation Requirements

1. Ensure that the area and equipment are cleaned and line clearance is obtained from QA.
2. Check and calibrate weighing balances and pH meters before use.
3. Verify availability of purified water (as per IP specifications) and all excipients required for gel base formation.

5.2 Dispensing of Ingredients

1. Dispense required quantities of ingredients like Carbomer, Hydroxypropyl Methylcellulose (HPMC), Propylene Glycol, etc., as per batch manufacturing record.
2. Ensure materials are labeled with status and used within retest or expiry period.

5.3 Gel Base Preparation

1. Fill the mixing vessel with a pre-calculated volume of purified water.
2. Begin stirring with the slow-speed stirrer and gradually add the gelling agent (e.g., Carbomer) while stirring continuously to avoid lump formation.
3. Continue mixing until a homogeneous dispersion is achieved (approximately 20–30 minutes depending on batch size).
4. Add humectants like Propylene Glycol or Glycerin while stirring slowly.

5.4 pH Adjustment

1. After full dispersion, use a calibrated pH meter to check the pH of the gel base.
2. If required, adjust the pH by adding dropwise neutralizing agents such as Triethanolamine or Sodium Hydroxide solution while stirring until the desired pH range (usually 5.0–7.0) is achieved.

5.5 Filtration and Holding

1. Filter the gel base using appropriate mesh (e.g., 100 mesh) to remove undissolved particles, if applicable.
2. Transfer to a pre-cleaned stainless steel holding vessel fitted with a lid and identification label.

5.6 In-Process Checks

• Appearance: Clear to slightly opalescent.
• pH: As per BMR (5.0–7.0).
• Viscosity: Within specified range using Brookfield Viscometer.
• Documentation of all observations in the BMR.

5.7 Precautions

• Do not add gelling agents too fast to avoid lumping.
• Do not exceed recommended stirring speed to avoid air entrapment.
• Always monitor temperature and pH during preparation.

6. Abbreviations

• API: Active Pharmaceutical Ingredient
• BMR: Batch Manufacturing Record
• GMP: Good Manufacturing Practices
• HPMC: Hydroxypropyl Methylcellulose

7. Documents

1. Batch Manufacturing Record – Annexure-1
2. Line Clearance Checklist – Annexure-2
3. Equipment Calibration Records – Annexure-3
4. In-process Check Log – Annexure-4

8. References

• ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• Schedule M – GMP for Pharmaceuticals
• Pharmacopoeia (IP/BP/USP) specifications

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: Batch Manufacturing Record

Includes detailed steps, quantities, and observational fields for gel base preparation.

Annexure-2: Line Clearance Checklist

To be filled before each gel batch preparation to ensure cleanliness and readiness of the area.

Annexure-3: Equipment Calibration Records

Log of last calibration for pH meters, balances, and mixing vessels used in the process.

Annexure-4: In-process Check Log

Document used to record pH, viscosity, appearance, and other control parameters during gel base formation.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/04/2022	1.0	Initial release	New SOP introduction	QA Head
02/06/2025	2.0	Added filtration and updated pH adjustment range	Annual review	QA Head