Standard Operating Procedure for Process Simulation Testing in Creams Production
1) Purpose
The purpose of this SOP is to define procedures for conducting process simulation testing in creams production. This ensures that manufacturing processes are validated under controlled conditions to mimic actual production scenarios.
2) Scope
This SOP applies to the Production Department responsible for conducting process simulation testing in creams production. It covers testing protocols, acceptance criteria, documentation, and reporting requirements.
3) Responsibilities
The Production Manager is responsible for overseeing process simulation testing. Production Supervisors and Manufacturing Technicians are responsible for executing and ensuring compliance with this SOP.
4) Procedure
4.1 Protocol Development
4.1.1 Develop process simulation testing protocols detailing the objectives, testing parameters, materials, equipment, and acceptance criteria.
4.1.2 Include worst-case scenarios and critical process steps in the protocols to ensure robustness of process simulation.
4.2 Test Execution
4.2.1 Conduct process simulation testing according to validated protocols and standard operating procedures.
4.2.2 Use representative materials and equipment to simulate actual production conditions.
4.2.3 Monitor critical process parameters (e.g., mixing times, temperatures, addition rates) throughout the simulation.
4.3 Sampling and Analysis
4.3.1 Collect samples at specified intervals during process simulation testing.
4.3.2 Analyze samples for critical quality attributes (e.g., content uniformity, viscosity, pH) using validated analytical methods.
4.4 Acceptance Criteria
4.4.1 Define acceptance criteria based on predefined limits for critical quality attributes and process parameters.
4.4.2 Evaluate process simulation testing results against acceptance criteria to confirm process robustness and consistency.
4.5 Documentation and Reporting
4.5.1 Document all phases of process simulation testing, including protocols, execution, sampling, analysis, and results.
4.5.2 Prepare process simulation reports summarizing testing procedures, results, conclusions, deviations, and corrective actions.
4.5.3 Obtain approval from Production Management for process simulation reports.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
Process Simulation Testing Protocols
Process Simulation Testing Reports
Validation Data and Raw Data Sheets
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Company-specific process validation guidelines and procedures
8) SOP Version
Version 1.0