Gel Manufacturing R&D department of the pharmaceutical unit.

3. Responsibilities

• Formulation Scientist: Responsible for preparing samples and coordinating with the analytical team.
• Quality Control Analyst: Responsible for testing physical, chemical, and microbiological parameters at defined intervals.
• R&D Supervisor: Responsible for reviewing data and making decisions on further formulation development.

4. Accountability

The Head – R&D shall be accountable for the implementation and compliance with this SOP.

5. Procedure

5.1 Sample Preparation

1. Prepare three representative gel batches (lab scale) using standard manufacturing procedures.
2. Fill approximately 20g of each gel formulation into clean, labeled laminated tubes or HDPE containers.
3. Ensure sample identification includes formulation code, batch number, date of manufacture, and analyst initials.

5.2 Storage Conditions

1. Store the filled containers at the following stability conditions:
   • Refrigerated: 5°C ± 3°C
   • Ambient: 25°C ± 2°C / 60% RH ± 5%
   • Accelerated: 40°C ± 2°C / 75% RH ± 5%

5.3 Time Points for Evaluation

1. Day 0 (Initial)
2. 1 Week
3. 2 Weeks
4. 4 Weeks

5.4 Parameters for Testing

1. Physical Appearance: Color, clarity, phase separation, and grittiness.
2. pH: Measured using a calibrated pH meter.
3. Viscosity: Determined using a Brookfield viscometer (RV or LV as applicable).
4. Assay: API content via validated HPLC or UV method.
5. Microbial Load: Total aerobic microbial count and fungal count.

5.5 Documentation and Analysis

1. Record results in Preliminary Stability Study Data Sheet (Annexure-1).
2. Summarize findings in Preliminary Stability Study Summary Report (Annexure-2).
3. Determine trends, degradation, or unacceptable changes that may influence final formulation design.

5.6 Acceptance Criteria

• No significant phase separation, discoloration, or odor development.
• pH variation within ±0.5 units from initial value.
• Assay within 95% to 105% of labeled claim.
• Total aerobic microbial count < 100 CFU/g; yeast and molds < 10 CFU/g.

6. Abbreviations

• SOP: Standard Operating Procedure
• API: Active Pharmaceutical Ingredient
• CFU: Colony Forming Units
• RH: Relative Humidity

7. Documents

1. Preliminary Stability Study Data Sheet – Annexure-1
2. Preliminary Stability Summary Report – Annexure-2
3. Microbial Testing Data Sheet – Annexure-3

8. References

• ICH Q1A(R2): Stability Testing of New Drug Substances and Products
• USP General Chapter <51> Antimicrobial Effectiveness Testing
• Internal formulation development reports

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: Preliminary Stability Study Data Sheet

Date	Condition	pH	Viscosity	Appearance	Assay (%)
Day 0	Ambient	6.5	18000	Clear gel	99.6

Annexure-2: Preliminary Stability Summary Report

Formulation Code	Storage Condition	Observations	Conclusion
GF-001	40°C/75% RH	Color change at 4 weeks	Requires preservative modification

Annexure-3: Microbial Testing Data Sheet

Sample ID	TAMC (CFU/g)	TYMC (CFU/g)	Complies
GEL-STB-001	10	2	Yes

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2022	1.0	Initial version	New SOP	Head – R&D
02/06/2025	2.0	Added microbial testing and acceptance criteria	Stability study expansion	Head – R&D