Standard Operating Procedure for Stability Testing of Aerosol Products

1) Purpose

The purpose of this SOP is to establish guidelines and procedures for conducting stability testing of aerosol products in the pharmaceutical industry. This ensures that the products maintain their quality, efficacy, and safety over their intended shelf-life.

2) Scope

This SOP applies to the Quality Control (QC) department at [Company Name], responsible for conducting stability testing on aerosol products according to regulatory requirements and company standards.

3) Responsibilities

QC Manager: Oversees stability testing procedures and ensures compliance with SOP.
Stability Analysts: Perform stability testing and monitor product stability over time.
Quality Assurance (QA) Personnel: Review stability data and ensure adherence to regulatory guidelines.

4) Procedure

4.1 Stability Study Protocol:
4.1.1 Develop a stability study protocol outlining testing conditions and parameters.
4.1.2 Define sampling points and storage conditions (e.g., temperature, humidity).

4.2 Sample Preparation:
4.2.1 Collect representative samples from each batch of aerosol products.
4.2.2 Ensure samples are stored in appropriate containers and labeled with batch details.

4.3 Testing Conditions:
4.3.1 Place samples in stability chambers set to specified conditions (e.g., accelerated, long-term stability).
4.3.2 Monitor samples at defined intervals for physical, chemical, and microbial stability.

4.4 Stability Testing:
4.4.1 Conduct tests such as appearance, pH, active ingredient content, and propellant content.
4.4.2 Perform microbiological testing to assess microbial growth over time.

4.5 Data Analysis and Reporting:
4.5.1 Record all stability test results accurately in stability study records.
4.5.2 Analyze data to determine product stability trends and shelf-life estimation.

4.6 Deviations and OOS:
4.6.1 Document any deviations from protocol or out-of-specification (OOS) results.
4.6.2 Investigate and report deviations to ensure corrective actions are implemented.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
OOS: Out of Specification

6) Documents, if any

Stability Study Protocol
Stability Study Records
Batch Manufacturing Record (BMR)

7) Reference, if any

ICH Guidelines for Stability Testing
FDA Guidance for Industry: Stability Testing of Drug Substances and Products

8) SOP Version

Version 1.0