by the Gel Manufacturing Department that require accelerated stability evaluation as part of product development, optimization, or regulatory filing.

3. Responsibilities

• Formulation Scientists: Prepare samples, define specifications, and design study protocol.
• Quality Control (QC): Execute analytical testing per approved methods.
• Quality Assurance (QA): Review documentation and ensure cGMP compliance.

4. Accountability

The Head of Gel Manufacturing is accountable for implementation and adherence to this SOP. The Head of QA is responsible for final approval and documentation compliance.

5. Procedure

5.1 Sample Preparation

1. Select three separate batches of the prototype gel (minimum 100 g each).
2. Transfer into high-quality, inert primary containers identical to final packaging material.
3. Label each container with batch number, sample ID, storage condition, and start date.

5.2 Storage Conditions

Samples shall be stored under the following ICH-recommended accelerated conditions:

• 40°C ± 2°C / 75% RH ± 5% RH (for climatic zone IV)
• Photostability chamber (if applicable) per ICH Q1B

5.3 Study Duration and Sampling Schedule

Time Points	Days	Tests to be Performed
Initial (T0)	Day 0	All parameters
1 Month	30	Critical parameters
2 Months	60	All parameters
3 Months	90	All parameters

5.4 Testing Parameters

• Appearance
• Color, Odor, and Consistency
• pH
• Viscosity
• Assay (API content)
• Microbial limit test
• Preservative efficacy (if applicable)

5.5 Analytical Methods

All methods used should be validated and documented in respective Method of Analysis (MoA). HPLC or UV should be used for assay. Brookfield viscometer is used for viscosity measurement.

5.6 Documentation and Reporting

• All test results shall be recorded in the Accelerated Stability Data Sheet (Annexure-1).
• Compile Stability Summary Report after 3 months using the format in Annexure-2.
• QA to archive results and approve continuation or formulation revision.

5.7 Acceptance Criteria

The product must remain within the predefined specification limits throughout the study period. Any deviations or trends must be analyzed for root cause and impact assessment.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• API: Active Pharmaceutical Ingredient
• RH: Relative Humidity

7. Documents

1. Accelerated Stability Data Sheet – Annexure-1
2. Stability Summary Report Format – Annexure-2
3. Method of Analysis (MoA) for Prototype Gels – Annexure-3

8. References

• ICH Q1A(R2): Stability Testing of New Drug Substances and Products
• ICH Q1B: Photostability Testing
• WHO Technical Report Series 1010 – Annex 10

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: Accelerated Stability Data Sheet

Time Point	Appearance	pH	Viscosity	Assay	Remarks
Initial	Clear gel	6.5	12000 cP	98.6%	Within spec
1 Month	No change	6.4	11800 cP	98.1%	Acceptable
2 Month	Slight opalescence	6.3	11700 cP	97.8%	Acceptable
3 Month	No significant change	6.3	11650 cP	97.5%	Pass

Annexure-2: Stability Summary Report Format

Parameter	Specification	Observed Range	Conclusion
Appearance	Clear or uniform gel	Stable throughout	Complies
Assay	95–105%	97.5–98.6%	Complies
pH	5.5–6.5	6.3–6.5	Complies

Annexure-3: Method of Analysis (MoA)

Refer to internal MoA document No. MOA/GM/019 for validated assay and physical tests applicable to prototype gels.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2022	1.0	Initial version issued	New SOP release	QA Head
02/06/2025	2.0	Added new annexures and revised sampling schedule	Annual review update	QA Head