various environmental conditions.

2. Scope

This SOP is applicable to the formulation development team, quality control, and stability study team involved in the evaluation of new or reformulated gel-based pharmaceutical products at the development stage.

3. Responsibilities

• Formulation Development Scientist: Responsible for initiating and executing stability studies as per protocol.
• QC Analyst: Responsible for conducting all required testing of stability samples.
• QA Officer: Responsible for reviewing data and ensuring compliance with stability study guidelines.

4. Accountability

The Head – Gel Manufacturing and Head – Quality Assurance shall be accountable for the implementation and compliance of this SOP.

5. Procedure

5.1 Preparation of Stability Protocol

1. Develop a study protocol detailing test parameters, storage conditions, sampling schedule, and evaluation criteria.
2. Include specifications for physical appearance, pH, viscosity, microbial limits, and active content assay.

5.2 Selection of Storage Conditions

1. Use the following storage conditions for preliminary studies:
   • 25°C ± 2°C / 60% RH ± 5%
   • 40°C ± 2°C / 75% RH ± 5%
   • Refrigerated (5°C ± 3°C)
2. Label each stability chamber and assign batch numbers for tracking.

5.3 Sampling Intervals

1. Collect stability samples at 0, 7, 14, 21, and 30 days.
2. Ensure each container is properly sealed and labeled with the date, batch number, and storage condition.

5.4 Evaluation Parameters

1. Visual Inspection: Check for phase separation, discoloration, precipitation, or microbial growth.
2. pH Measurement: Use calibrated pH meter (see SOP/GM/044/2025).
3. Viscosity: Use Brookfield viscometer with appropriate spindle.
4. Assay: Determine drug content using validated HPLC or UV spectroscopic methods.
5. Microbial Testing: Conduct total viable count and test for pathogens like E. coli and S. aureus.

5.5 Data Recording

1. Record all observations and test results in the Preliminary Stability Data Sheet (Annexure-1).
2. Use Annexure-2 for sample inventory tracking and chain of custody documentation.

5.6 Review and Conclusion

1. Analyze trends over time for each parameter under each storage condition.
2. Summarize results and indicate stability risks, if any, in the Preliminary Stability Study Report (Annexure-3).
3. Use results to refine formulation or adjust preservative systems if needed.

6. Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control
• QA: Quality Assurance
• RH: Relative Humidity
• HPLC: High Performance Liquid Chromatography

7. Documents

1. Preliminary Stability Data Sheet – Annexure-1
2. Stability Sample Tracking Sheet – Annexure-2
3. Preliminary Stability Study Report – Annexure-3

8. References

• ICH Q1A(R2): Stability Testing of New Drug Substances and Products
• WHO Technical Report Series No. 1010 – Stability Studies
• Pharmaceutical Stability Studies Guidelines (CDSCO India)

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 Data Sheet

Batch No.	Condition	Day	pH	Viscosity (cP)	Appearance	Assay (%)
GEL2025A	40°C/75% RH	14	6.2	8500	Clear, no phase separation	98.7%

Annexure-2: Stability Sample Tracking Sheet

Sample ID	Storage Condition	Location	Date In	Date Out	Tested By
GEL014-P-40A	40°C/75% RH	Chamber-2	02/06/2025	16/06/2025	QC-05

Annexure-3: Preliminary Stability Study Report

• Batch Evaluated: GEL2025A
• Conditions: 25°C/60% RH, 40°C/75% RH, 5°C
• Duration: 30 Days
• Observations: Stable under all tested conditions
• Recommendation: Proceed to accelerated and long-term stability studies

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
02/06/2022	1.0	Initial version issued	New formulation testing	QA Head
02/06/2025	2.0	Expanded to include microbial and inventory tracking	Regulatory enhancement	QA Head