results, verifying compliance with specifications, and approving the release of stability data for regulatory submission or product release.

4. Accountability

The QC Manager is accountable for ensuring that accelerated stability testing is carried out as per this SOP. The Production Supervisor is responsible for ensuring that samples are properly collected and labeled. The QA Manager ensures the integrity and compliance of stability testing with regulatory requirements.

5. Procedure

5.1 Pre-Test Preparation

1. Ensure that all necessary equipment for accelerated stability testing is available, including temperature-controlled stability chambers, humidity control units, and sample containers.
2. Ensure that the stability chambers are calibrated and operating at the desired temperature (e.g., 40°C) and humidity (e.g., 75%) before testing.
3. Review the formulation batch records to determine which cream formulations are ready for stability testing and to identify the number of samples required.

5.2 Sample Collection

1. Collect representative samples of the cream formulation to be tested. The sample size should be sufficient to perform tests at various time intervals.
2. Label each sample with relevant information, including the batch number, sampling date, and the purpose of the test (e.g., accelerated stability testing).
3. Ensure that the sample containers are sealed properly to prevent contamination or leakage during storage.

5.3 Accelerated Stability Testing Procedure

1. Place the labeled samples in the stability chamber set at the predefined temperature and humidity conditions (e.g., 40°C and 75% RH) to simulate accelerated aging conditions.
2. Monitor the temperature and humidity levels inside the chamber to ensure they remain within the specified range throughout the testing period.
3. Analyze the samples at designated time intervals, typically at 1, 2, 3, and 6 months. At each interval, test for the following attributes:
   • Physical Appearance: Inspect for changes in color, consistency, or phase separation.
   • Viscosity: Measure the viscosity using a viscometer to ensure it remains within specification.
   • pH Level: Measure the pH using a pH meter to ensure the formulation remains within the desired pH range.
   • Microbial Testing: Conduct microbial limit testing to ensure the cream remains free from microbial contamination.
   • Odor and Texture: Check for any off-odor or texture changes that may indicate instability.
4. Document all observations and test results, including any deviations or unexpected changes, in the Accelerated Stability Testing Log (Annexure-1).

5.4 Interpretation of Results

1. Compare the test results at each time interval with the baseline data from the initial test (e.g., viscosity, pH, physical appearance).
2. If any of the product characteristics fall outside the established limits (e.g., significant color change, viscosity decrease, pH shift), mark the test as “Fail” in the Accelerated Stability Testing Log (Annexure-1).
3. If the product remains stable according to all specified criteria, mark the test as “Pass” and proceed with further testing or packaging if required.
4. If failures occur, initiate an investigation into the cause of the instability. This may include reviewing raw material specifications, manufacturing processes, or storage conditions.

5.5 Post-Test Activities

1. Record the test results, including batch number, sample ID, time intervals, and all relevant observations, in the Accelerated Stability Testing Log (Annexure-1).
2. Review all data and investigate any deviations from expected results. If necessary, implement corrective actions or adjustments to the formulation and re-test the samples.
3. Submit the stability test results for approval by the QA team before proceeding with any product release or further production activities.

5.6 Documentation and Record-Keeping

1. Ensure that all stability testing records are complete, accurate, and securely stored. This includes the Accelerated 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: Accelerated 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: Accelerated Stability Testing Log

Batch Number	Sample ID	Sampling Date	Temperature (°C)	Humidity (%)	Viscosity (cP)	pH	Physical Appearance	Operator
12345	S-001	21/01/2026	40°C	75%	500 cP	5.5	No visible changes	John Doe

Annexure-2: Deviation Log

Deviation Date	Batch Number	Deviation Description	Corrective Action Taken	Operator
21/01/2026	12345	Viscosity decreased beyond acceptable limit	Reviewed formulation, adjusted ingredient ratio	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