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,