Standard Operating Procedure for Process Simulation Testing in Aerosol Production
1) Purpose
The purpose of this SOP is to define the procedures for conducting process simulation testing in aerosol production to validate the effectiveness of manufacturing processes and ensure product quality and consistency.
2) Scope
This SOP applies to process simulation testing conducted for aerosol production at [Company Name], including but not limited to formulation, filling, propellant charging, and packaging processes.
3) Responsibilities
Production Team: Perform process simulation experiments and monitor process parameters.
Quality Assurance (QA) Team: Oversee compliance with SOPs and regulatory requirements during process simulation testing.
Quality Control (QC) Team: Analyze samples and perform in-process testing during process simulation.
Engineering Team: Maintain and calibrate equipment used in process simulation experiments.
4) Procedure
4.1 Preparation for Process Simulation:
4.1.1 Review and approve the process simulation protocol outlining simulation steps, acceptance criteria, and sampling plan.
4.1.2 Verify availability and readiness of equipment, raw materials, and personnel for process simulation testing.
4.1.3 Conduct equipment calibration and ensure all instruments are functioning within specified limits.
4.2 Execution of Process Simulation: 4.3 In-process Testing and Sampling: 4.4 Evaluation of Process Performance: 4.5 Data Analysis and Reporting: SOP: Standard Operating Procedure Process Simulation Protocol FDA Guidance for Industry: Process Validation: General Principles and Practices Version 1.0
4.2.1 Prepare the aerosol formulation according to the approved batch record and SOPs.
4.2.2 Initiate filling and propellant charging processes under simulated production conditions.
4.3.1 Collect samples at defined intervals during process simulation for in-process testing.
4.3.2 Perform analytical tests (e.g., assay, particle size distribution, propellant content) on samples as per the sampling plan.
4.3.3 Document and evaluate results against acceptance criteria to ensure process consistency and product quality.
4.4.1 Assess process performance based on observed results and deviations from expected outcomes.
4.4.2 Identify and investigate any discrepancies or non-conformances observed during process simulation.
4.4.3 Implement corrective actions as necessary to address identified issues and prevent recurrence.
4.5.1 Compile process simulation data, including experimental observations, analytical results, and deviations.
4.5.2 Prepare a comprehensive process simulation report summarizing the outcomes, conclusions, and recommendations.
4.5.3 Review and approve the process simulation report by designated personnel to ensure accuracy and compliance with SOPs.5) Abbreviations, if any
QA: Quality Assurance
QC: Quality Control
SOP: Standard Operating Procedure6) Documents, if any
Process Simulation Report
In-process Testing Results
Calibration Records for Equipment
Approval Records and Documentation7) Reference, if any
ICH Q9: Quality Risk Management
USP Chapter 8) SOP Version
