Standard Operating Procedure for Process Validation Protocols for Aerosols
1) Purpose
The purpose of this SOP is to define the procedures for conducting process validation protocols for aerosol production. Process validation ensures that aerosol manufacturing processes consistently produce products of predetermined quality attributes, meeting regulatory and customer requirements.
2) Scope
This SOP applies to all stages of process validation protocols conducted for aerosol production processes at [Company Name].
3) Responsibilities
Quality Assurance (QA) Manager: Oversee process validation activities and ensure compliance with SOPs.
Production Manager: Implement process validation protocols and coordinate with cross-functional teams.
Validation Team: Execute process validation studies and document results.
Regulatory Affairs: Provide guidance on regulatory requirements for process validation protocols.
4) Procedure
4.1 Protocol Development:
4.1.1 Define the scope and objectives of the process validation study based on product characteristics and regulatory requirements.
4.1.2 Develop a detailed validation protocol outlining acceptance criteria, test methods, sampling plan, and validation timeline.
4.1.3 Obtain necessary approvals for the validation protocol from relevant stakeholders.
4.2 Installation Qualification (IQ):
4.2.1 Verify and document that all equipment used in the aerosol production process is installed correctly according to specifications.
4.2.2 Ensure that utilities (e.g., air supply, electrical power) are adequate and functioning as required.
4.2.3
4.3 Operational Qualification (OQ):
4.3.1 Validate that the aerosol production equipment operates within defined parameters and tolerances.
4.3.2 Conduct performance testing under normal operating conditions to verify equipment functionality.
4.3.3 Document OQ results, including test data and acceptance criteria compliance.
4.4 Performance Qualification (PQ):
4.4.1 Execute process simulations using production equipment and materials to demonstrate process capability.
4.4.2 Monitor critical process parameters (CPPs) and evaluate product outputs against predetermined specifications.
4.4.3 Analyze PQ data to confirm process consistency and reproducibility.
4.5 Validation Report:
4.5.1 Compile all validation data, including protocols, test results, and deviations, into a comprehensive validation report.
4.5.2 Document conclusions and recommendations based on validation findings, including any corrective actions taken.
4.5.3 Obtain final approval of the validation report from QA and other relevant departments.
4.6 Continued Process Verification:
4.6.1 Establish a plan for ongoing monitoring and verification of the validated process.
4.6.2 Conduct periodic reviews and assessments to ensure ongoing process control and compliance.
4.6.3 Update validation protocols as necessary based on changes in equipment, materials, or regulatory requirements.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
IQ: Installation Qualification
OQ: Operational Qualification
PQ: Performance Qualification
CPPs: Critical Process Parameters
6) Documents, if any
Process Validation Protocol
Validation Master Plan
IQ/OQ/PQ Test Reports
Validation Summary Report
7) Reference, if any
FDA Guidance for Industry: Process Validation: General Principles and Practices
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes
8) SOP Version
Version 1.0