reviewing the stability testing results, ensuring that the product meets the required specifications, and determining the final shelf life based on the test results.

4. Accountability

The QC Manager is accountable for ensuring that stability testing is conducted in accordance with this SOP. The Production Supervisor is responsible for ensuring that the cream formulations are prepared according to the formulation and sent for stability testing. The QA Manager ensures that the test results are reviewed and the shelf life is approved in compliance with GMP and regulatory standards.

5. Procedure

5.1 Pre-Test Preparation

1. Ensure that the necessary equipment and testing materials for stability studies are available, including stability chambers, temperature and humidity controls, and sample containers that meet regulatory requirements.
2. Review the batch record to confirm the formulation details and identify the specific storage conditions for the stability study (e.g., room temperature, accelerated conditions, or refrigerated conditions).
3. Prepare the cream samples according to the formulation and ensure that each batch is prepared in a consistent manner.
4. Label each sample with the batch number, sample ID, testing start date, and any other relevant details to ensure traceability during testing.

5.2 Stability Testing Procedure

1. Place the cream samples in the stability chamber, ensuring that the conditions (temperature, humidity, and light) are set according to the defined study parameters.
2. Conduct stability testing at different intervals (e.g., 0 months, 1 month, 3 months, 6 months, 12 months) as per the required study protocol.
3. For each interval, test the cream samples for relevant physical, chemical, and microbiological properties, such as pH, viscosity, appearance, odor, microbial load, and active ingredient content.
4. Record the results of each test, including the date of testing and any observations related to changes in the product, in the Stability Testing Log (Annexure-1).

5.3 Interpretation of Results

1. Compare the results from each testing interval with the initial sample’s baseline results to determine if there is any degradation, change in appearance, or loss of active ingredient concentration.
2. If the product shows no significant changes in its physical and chemical properties within the specified shelf life, the cream is considered stable for the duration of the study.
3. If the product exhibits significant changes (e.g., changes in pH, viscosity, or microbial contamination), investigate the cause of instability and take corrective actions. Mark the test as “Fail” in the Stability Testing Log (Annexure-1).
4. Based on the results, determine the maximum shelf life and storage conditions for the cream formulation.

5.4 Post-Test Activities

1. Record all results in the Stability Testing Log (Annexure-1), including batch number, sample ID, and test dates for each interval.
2. If the stability test fails, initiate corrective actions, such as adjusting the formulation or improving the manufacturing process. Re-test the sample after corrective actions.
3. Submit the test results for review and approval by the QA team, and update the product’s shelf life based on the stability study results.

5.5 Documentation and Record-Keeping

1. Ensure that all stability testing records are complete, accurate, and securely stored. This includes the Stability Testing Log (Annexure-1) and the Deviation Log (Annexure-2) for failed tests.
2. Retain all records for a minimum of two years or as required by regulatory guidelines.
3. Ensure that records are reviewed and approved by the Quality Assurance team to verify compliance with GMP standards and regulatory requirements.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment

7. Documents

1. Annexure-1: Stability Testing Log
2. Annexure-2: Deviation Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• Pharmacopeial Monographs for Stability Testing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Stability Testing Log

Batch Number	Sample ID	Test Date	pH	Viscosity	Appearance	Microbial Load	Active Ingredient Content (%)	Operator
12345	S-001	21/01/2026	7.4	2500 cP	Clear	Pass	98.5%	John Doe

Annexure-2: Deviation Log

Deviation Date	Batch Number	Deviation Description	Corrective Action Taken	Operator
21/01/2026	12345	Viscosity exceeded specification	Reformulated the batch, adjusted the mixing process	Jane Smith

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head