SOP Guide for Pharma

Aerosol: SOP for Stability Testing During Product Development – V 2.0

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Aerosol: SOP for Stability Testing During Product Development – V 2.0

SOP for Stability Testing During Product Development

Department Aerosol
SOP No. SOP/Aerosol/014/2025
Supersedes SOP/Aerosol/014/2022
Page No. Page 1 of Y
Issue Date 06/02/2025
Effective Date 16/02/2025
Review Date 06/02/2028

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for conducting stability testing during the development of aerosol products. It ensures that aerosol formulations maintain their desired quality attributes, such as efficacy, appearance, and performance, under various environmental conditions over time. Stability testing helps to establish product shelf life, define storage conditions, and ensure regulatory compliance.

2. Scope

This procedure applies to all aerosol products under development at [Company Name]. It includes stability testing for raw materials, in-process formulations, and finished products. This SOP covers the required testing conditions, testing intervals, documentation, and reporting necessary to ensure the stability of aerosol products during product development. It does not apply to routine product testing or post-production testing.

3. Responsibilities

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.

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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.
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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.
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6. Abbreviations

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:

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
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