Procedure for Extractables and Leachables Testing in Aerosol Products

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for conducting extractables and leachables (E&L) testing in aerosol products to ensure product safety and compliance with regulatory guidelines.

2. Scope

This SOP applies to all aerosol formulations where packaging components (valves, actuators, containers, etc.) may interact with the drug product, leading to potential contamination.

3. Responsibilities

• Quality Control (QC) Analysts: Responsible for conducting E&L testing.
• Quality Assurance (QA) Team: Responsible for reviewing test results and approving compliance.
• Laboratory Supervisor: Responsible for ensuring E&L testing follows validated procedures.
• Regulatory Affairs Team: Responsible for ensuring compliance with global regulatory standards.

4. Accountability

The Quality Control Manager is accountable for ensuring the accuracy and compliance of extractables and leachables testing.

5. Procedure

5.1. Selection of Test Components

1. Identify primary and secondary packaging components for E&L testing.
2. Record test components in the E&L Component Selection Log (Annexure-1).

5.2. Extractables Testing

1. Perform solvent extraction using water, ethanol, and hexane.
2. Analyze extracted substances using GC-MS and LC-MS.
3. Record results in the Extractables Test Log (Annexure-2).

5.3. Leachables Testing

1. Store aerosol samples at accelerated stability conditions.
2. Periodically analyze leachables using validated methods.
3. Record test results in