regulatory requirements.

4. Accountability

The QC Manager is accountable for ensuring that odor stability testing is performed according to this SOP. The Production Supervisor is responsible for providing the representative samples for testing. The QA Manager ensures that the test results are reviewed and approved in compliance with GMP and regulatory standards.

5. Procedure

5.1 Pre-Test Preparation

1. Ensure that the necessary equipment for odor stability testing is available, including properly ventilated sample containers, odor-neutral environments, and any required testing instruments (e.g., olfactometers for objective assessment).
2. Review the batch record to confirm the ingredients used in the cream formulation and the expected fragrance or odor profile of the product.
3. Ensure the availability of trained panelists or assessors who can evaluate the odor characteristics during the test period.

5.2 Sample Collection

1. Collect representative samples of the cream formulation at different time points, including freshly produced cream and samples at intervals during stability testing (e.g., 0, 7, 14, 21, and 28 days).
2. Label each sample with the batch number, sample ID, sampling date, and storage conditions to ensure traceability during testing.
3. Ensure that the samples are taken from sealed containers to maintain the integrity of the product’s odor profile.

5.3 Odor Stability Testing Procedure

1. Place the cream samples under specified storage conditions for accelerated stability (e.g., elevated temperature and humidity) or long-term storage (e.g., 25°C, 60% RH).
2. At each specified time point, open the sample container and allow the odor to stabilize in a controlled environment.
3. Conduct odor evaluations using a trained panel of assessors or using an olfactometer. The panel should assess the odor intensity, quality, and any changes in the fragrance over time.
4. Record the odor evaluation results using a sensory evaluation sheet or other suitable documentation methods. The panelists should note any changes in odor, such as degradation or off-odors.
5. For objective measurements, an olfactometer can be used to quantify odor intensity. This can provide a more standardized approach for odor stability assessment.

5.4 Interpretation of Results

1. Compare the odor characteristics at each time point with the initial sample’s odor profile. A significant change in odor (e.g., unpleasant or off-odors) indicates a failure in odor stability.
2. Record any deviations or changes in odor in the Odor Stability Test Log (Annexure-1). If the sample passes the test, mark the result as “Pass.” If it fails, mark the result as “Fail.”
3. If a failure occurs, investigate the cause of the odor degradation, which may include improper formulation, unstable ingredients, or poor storage conditions.

5.5 Post-Test Activities

1. Record all test results, including batch number, sample ID, time points, odor evaluation results, and any corrective actions taken in the Odor Stability Test Log (Annexure-1).
2. If a sample fails the test, initiate corrective actions, such as reformulating the cream, adjusting the preservative system, or modifying storage conditions. Re-test the sample after corrective actions.
3. Submit the test results for review and approval by the QA team to ensure compliance with internal and regulatory standards.

5.6 Documentation and Record-Keeping

1. Ensure that all odor stability testing records are complete, accurate, and securely stored. This includes the Odor Stability Test 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: Odor Stability Test 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
• ISO 9001 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Odor Stability Test Log

Batch Number	Sample ID	Test Date	Odor Evaluation (Intensity/Description)	Operator
12345	S-001	21/01/2026	Pass (No off-odor, stable fragrance)	John Doe

Annexure-2: Deviation Log

Deviation Date	Batch Number	Deviation Description	Corrective Action Taken	Operator
21/01/2026	12345	Off-odor detected in sample after 14 days	Reformulated, re-tested	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