Standard Operating Procedure for Conducting Process Validation for Aerosols

1) Purpose

The purpose of this SOP is to establish procedures for conducting process validation activities for aerosol production processes in the pharmaceutical industry. Process validation ensures that aerosol manufacturing processes consistently produce products of the desired quality.

2) Scope

This SOP applies to all aerosol production processes at [Company Name], including formulation, filling, and packaging processes requiring validation to ensure compliance with regulatory requirements.

3) Responsibilities

Quality Assurance (QA) Manager: Oversees process validation activities and documentation.
Production Manager: Coordinates process validation studies and implementation.
Validation Team: Conducts validation protocols and prepares validation reports.

4) Procedure

4.1 Protocol Development:
4.1.1 Define the scope, objectives, and acceptance criteria for process validation.
4.1.2 Develop validation protocols outlining test methods, sampling plans, and acceptance criteria.

4.2 Process Qualification:
4.2.1 Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) as applicable.
4.2.2 Verify equipment installation, functionality, and process performance under normal operating conditions.

4.3 Process Monitoring:
4.3.1 Monitor critical process parameters during production runs to ensure process consistency.
4.3.2 Use validated monitoring and control systems to collect and analyze data.

4.4 Process Validation Report:
4.4.1 Compile data and results from process validation studies.
4.4.2 Evaluate compliance with acceptance