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 criteria and summarize findings in a validation report.
4.5 Continued Process Verification:
4.5.1 Implement ongoing monitoring and verification activities to ensure sustained process performance.
4.5.2 Review and update process validation documentation as part of continuous improvement efforts.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
IQ: Installation Qualification
OQ: Operational Qualification
PQ: Performance Qualification
6) Documents, if any
Process Validation Protocols
Validation Reports
Data Analysis and Summary Sheets
7) Reference, if any
FDA Guidance for Industry: Process Validation: General Principles and Practices
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0
