gel product.

2. Scope

This procedure is applicable to the Gel Manufacturing Department and shall be followed for all products where APIs are incorporated into a previously prepared gel base.

3. Responsibilities

• Production Chemist: Execute the procedure as per instructions in this SOP.
• Quality Assurance (QA): Verify the process and document review.
• Warehouse Personnel: Dispense APIs according to the approved Batch Manufacturing Record (BMR).

4. Accountability

Head – Manufacturing and QA Head shall be accountable for the compliance and effective implementation of this SOP.

5. Procedure

5.1 Pre-Addition Checklist

1. Ensure the gel base has been prepared and its parameters (pH, viscosity, appearance) meet specification.
2. Confirm that line clearance has been obtained from QA before starting the activity.
3. Check the label and status of the API container and verify the material identity and quantity against the BMR.

5.2 Dispersion Method Selection

1. If the API is water-soluble, dissolve it in a pre-measured volume of purified water and add directly to the gel base under continuous mixing.
2. If the API is oil-soluble or insoluble, create a fine suspension using appropriate vehicle (e.g., Propylene Glycol) and add gradually.

5.3 Addition to Gel Base

1. Transfer the API solution/suspension slowly into the mixing vessel containing the gel base.
2. Use a slow-speed stirrer initially to incorporate the API without causing air entrapment.
3. Once uniformly mixed, switch to a high-shear mixer or homogenizer if required for better dispersion.
4. Ensure uniformity by conducting visual checks and sampling at different points.

5.4 In-Process Verification

1. Perform pH and viscosity checks after API addition to ensure the formulation remains within specifications.
2. Conduct sampling from top, middle, and bottom layers to assess content uniformity.
3. Document all observations in the BMR.

5.5 Post-Addition Instructions

1. Label the bulk gel with details like product name, batch number, stage, and date.
2. Transfer to a designated holding vessel for subsequent processing (e.g., deaeration or filling).

5.6 Precautions

• Use APIs only from approved and released batches.
• Maintain cleanliness of equipment to prevent cross-contamination.
• Handle hygroscopic APIs under controlled humidity conditions.

6. Abbreviations

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

7. Documents

1. Batch Manufacturing Record – Annexure-1
2. Line Clearance Form – Annexure-2
3. API Addition Log Sheet – Annexure-3
4. In-Process Check Record – Annexure-4

8. References

• ICH Q8: Pharmaceutical Development
• Schedule M: Good Manufacturing Practices
• Internal SOP for Gel Base Preparation

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

Template to record quantities, timing, and mixing conditions during API addition.

Annexure-2: Line Clearance Form

Checklist to confirm the area and equipment are cleared before API addition.

Annexure-3: API Addition Log Sheet

Details of operator, date, time, and observations made during API incorporation.

Annexure-4: In-Process Check Record

pH, viscosity, and uniformity test records post API addition.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
30/04/2022	1.0	Initial version issued	New product implementation	QA Head
02/06/2025	2.0	Updated procedure for insoluble APIs and in-process checks	Annual review and optimization	QA Head