Assurance (QA) Team: Responsible for reviewing the results of the stability testing and ensuring that the product meets the required specifications for stability under various humidity conditions.

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 samples are prepared and packaged for testing under controlled humidity conditions. The QA Manager is responsible for reviewing the test results and ensuring that the cream formulations meet the required specifications for stability.

5. Procedure

5.1 Pre-Test Preparation

1. Ensure that the necessary equipment for stability testing is available, including a humidity-controlled stability chamber, temperature and humidity sensors, and sample containers that are suitable for the cream formulations.
2. Review the formulation and batch record to confirm that all ingredients and quantities are accurate and that the cream sample is representative of the production batch.
3. Label each sample with the batch number, sample ID, testing start date, and humidity conditions to ensure proper traceability during the test.
4. Prepare the cream samples in the required packaging to simulate real-life storage conditions (e.g., jars, tubes, or sachets). Ensure that the packaging is sealed and appropriately labeled for identification.

5.2 Stability Testing under Varying Humidity Conditions

1. Place the cream samples in the stability chamber, ensuring that the humidity is set to the required levels (e.g., 30%, 60%, and 90% relative humidity) for testing. Record the initial conditions of the chamber, including temperature and humidity settings.
2. Maintain the samples in the chamber for the required period, which may vary depending on the study protocol (typically 1 month, 3 months, 6 months, and 12 months).
3. At specified intervals (e.g., 1 month, 3 months, 6 months), remove the cream samples from the chamber and perform physical, chemical, and microbiological testing to evaluate the impact of humidity on the cream. Testing parameters may include:
   • Viscosity
   • pH
   • Appearance (color, texture)
   • Active ingredient content
   • Microbial contamination levels
4. Record the results of each test, including the testing date, sample ID, and humidity condition, in the Stability Testing Log (Annexure-1).

5.3 Data Analysis and Interpretation

1. Analyze the results of the tests to determine if there are any significant changes in the cream formulations under different humidity conditions. Focus on changes in physical properties (e.g., appearance, texture) and active ingredient stability.
2. If the product meets the established criteria for stability under varying humidity conditions, mark the test as “Pass” in the Stability Testing Log (Annexure-1) and proceed with the next stage of production or release.
3. If the product shows signs of degradation or instability (e.g., changes in viscosity, pH, or active ingredient content), mark the test as “Fail.” Investigate the potential causes of instability, which may include formulation issues, packaging problems, or improper storage conditions.

5.4 Post-Test Activities

1. Record all test results, including batch number, sample ID, test date, humidity condition, and any deviations from the specifications, in the Stability Testing Log (Annexure-1).
2. If the stability test fails, initiate corrective actions, such as reformulating the product, improving packaging, or modifying the manufacturing process. Re-test the sample after corrective actions have been implemented.
3. Submit the test results for review and approval by the QA team to ensure compliance with internal and regulatory standards.

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 on 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	Humidity Condition	pH	Viscosity	Appearance	Active Ingredient Content (%)	Operator
12345	S-001	21/01/2026	30% RH	7.4	2500 cP	Clear	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 batch and adjusted humidity conditions	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