interactions.

4. Accountability

The Head – Manufacturing is accountable for ensuring adherence to this SOP, compliance with regulatory standards, and product release based on QA clearance.

5. Procedure

5.1 Pre-Manufacturing Preparation

1. Review the approved Master Formula Record (MFR) for SR gel batch.
2. Ensure availability of all required materials: APIs, SR polymers (e.g., HPMC, Carbopol, Ethyl Cellulose), solvents, excipients.
3. Verify calibration status of weighing balances, homogenizers, mixers, and pH meters.

5.2 Weighing and Dispensing

1. Dispense all raw materials in a designated dispensing area as per the MFR.
2. Document batch numbers, weights, and AR Nos. in the dispensing log sheet.

5.3 Preparation of Sustained Release Gel

1. Dissolve the sustained release polymer in a compatible solvent or aqueous medium using a slow-speed stirrer to avoid lumping.
2. Allow adequate hydration time (e.g., 2–4 hours) based on polymer type.
3. Add actives gradually into the hydrated polymer solution under continuous stirring.
4. Use homogenization (as required) to ensure uniformity of dispersion.
5. Adjust pH using neutralizing agents (e.g., TEA) to achieve desired viscosity and gel consistency.

5.4 In-Process Checks

1. Check and record pH, viscosity, and homogeneity of the prepared gel.
2. Verify batch yield and ensure no visible lumps or phase separation.

5.5 Filling and Packing

1. Transfer the gel to pre-cleaned, labeled containers or filling machines.
2. Fill into tubes/jars using a calibrated filling machine under controlled conditions.
3. Ensure label reconciliation and perform visual inspection before packing.

5.6 Cleaning and Documentation

1. Clean all equipment and utensils as per the equipment cleaning SOP.
2. Document cleaning activities and batch manufacturing records.

6. Abbreviations

• SR: Sustained Release
• API: Active Pharmaceutical Ingredient
• MFR: Master Formula Record
• QA: Quality Assurance

7. Documents

1. Master Formula Record – Annexure-1
2. Dispensing Log Sheet – Annexure-2
3. Batch Manufacturing Record – Annexure-3
4. In-Process Control Log – Annexure-4
5. Cleaning Log Sheet – Annexure-5

8. References

• ICH Q8: Pharmaceutical Development
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO TRS 1010 – Annex 3, Gel Formulation Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Formulation Scientist	QA Officer	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Master Formula Record

Component	Quantity (g)	Function

Annexure-2: Dispensing Log Sheet

Material	AR No.	Qty Dispensed	Dispensed By

Annexure-3: Batch Manufacturing Record

Stage	Activity	Time	Performed By

Annexure-4: In-Process Control Log

Parameter	Specification	Observed Value	Remarks
pH	6.0–7.5
Viscosity	As per MFR

Annexure-5: Cleaning Log Sheet

Equipment	Cleaned By	Date	Verified By

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
15/05/2022	1.0	Initial issue	New SOP	QA Head
09/06/2025	2.0	Added sustained release process and in-process checks	Process Optimization	QA Head