Ensures that product formulations meet the specifications established during the stability testing phase and assists with sample preparation.

4. Accountability

The R&D Manager is accountable for ensuring that this SOP is followed during the stability testing of aerosol products. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Stability Testing Plan

1. Define the stability testing objectives based on the product type, formulation, intended use, and market regulations. Determine the required tests (e.g., chemical stability, physical stability, microbiological stability) based on product requirements.
2. Develop a testing plan that outlines the testing intervals (e.g., 0, 3, 6, 9, 12 months), environmental conditions (e.g., temperature, humidity, light exposure), and the specific parameters to be evaluated.
3. The testing conditions must simulate the product’s intended storage and transport environments. For example, testing should be conducted at accelerated conditions (e.g., 40°C ± 2°C and 75% RH ± 5%) and real-time conditions.

5.2. Sample Preparation

1. Prepare the samples to be tested according to the final formulation and packaging specifications. Use representative batches of the aerosol formulation, ensuring consistency in material quality, weight, and packaging components.
2. Label the samples with batch numbers, manufacturing dates, and specific identifiers to ensure traceability.
3. Ensure that samples are placed in appropriate storage containers and packaging (e.g., aerosol cans) for testing, taking care to avoid contamination or damage during handling.

5.3. Conducting Stability Tests

1. Stability tests should be performed according to the defined testing plan. The following key tests should be included:
   • Physical stability tests: Evaluate spray pattern, particle size, appearance, and any visible changes in the formulation (e.g., phase separation or sedimentation).
   • Chemical stability tests: Monitor the active ingredient concentration, propellant stability, and any degradation products over time.
   • Packaging integrity tests: Check for leakage, damage, or changes in the container and valve system over the testing period.
   • Microbiological stability tests: Ensure that the product remains free from microbial contamination during the testing period (if applicable).
2. Record all results in the Stability Testing Log (Annexure-1), including observations, measurements, and test dates. Ensure all data is accurate, complete, and consistent with regulatory requirements.
3. Monitor the stability of the formulation under the specified storage conditions. Record environmental parameters (e.g., temperature and humidity) regularly and document deviations, if any, during the testing period.

5.4. Data Analysis and Interpretation

1. After each testing interval, analyze the results to determine any trends or deviations from the expected product specifications.
2. If the product shows signs of instability (e.g., degradation, physical changes), identify the potential cause and assess whether any modifications to the formulation or packaging are necessary.
3. Based on the results, calculate the product’s shelf life and define the recommended storage conditions (e.g., temperature range, humidity levels) to ensure product integrity throughout its life cycle.

5.5. Stability Report and Documentation

1. Prepare a comprehensive Stability Report (Annexure-2) summarizing all test results, observations, deviations, and the final shelf life determination.
2. The report should also include recommendations for packaging, storage conditions, and any necessary adjustments to the formulation or manufacturing process based on the stability results.
3. Submit the report for review and approval by the Quality Assurance team and regulatory affairs team.

5.6. Corrective and Preventive Actions (CAPA)

1. If stability testing reveals any issues (e.g., instability, contamination, degradation), initiate corrective actions to resolve the issues. For example, reformulate the product, improve packaging, or revise storage recommendations.
2. Preventive actions should be implemented to avoid recurrence of similar stability issues in future products, such as revising formulation practices, improving material sourcing, or enhancing storage and handling protocols.
3. Document all corrective and preventive actions in the CAPA Log (Annexure-3) and track the effectiveness of the actions taken.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• CAPA: Corrective and Preventive Actions
• R&D: Research and Development

7. Documents

1. Stability Testing Log (Annexure-1)
2. Stability Report (Annexure-2)
3. CAPA Log (Annexure-3)
4. Environmental Monitoring Log (Annexure-4)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems
• ICH Q1A(R2) – Stability Testing of New Drug Substances and Products

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

Test Parameter	Test Date	Test Result	Observations	Tested By
Viscosity	06/02/2025	Pass	No visible change	Rajesh Patel

Annexure-2: Stability Report

Batch No.	Product Name	Shelf Life Determination	Storage Conditions	Approval Date
12345	Example Aerosol	24 months	20°C ± 2°C, 60% RH	06/02/2025

Annexure-3: CAPA Log

Issue	Root Cause	Corrective Action	Preventive Action	Follow-up Date
Phase separation	Incompatibility with excipient	Reformulated with alternative excipient	Enhanced ingredient compatibility testing	06/03/2025

Annexure-4: Environmental Monitoring Log

Test Date	Temperature	Humidity	Test Result	Operator
06/02/2025	20°C	60% RH	Pass	Ravi Kumar

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated stability testing protocols	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures