Standard Operating Procedure for Equipment Validation of Sterile Filtration Skid in IV Infusions
Purpose: This SOP outlines the validation process for the Sterile Filtration Skid utilized in the production of IV infusions, ensuring compliance with regulatory standards and product quality.
Scope: This procedure applies to the Sterile Filtration Skid used for sterilizing filtration before filling LVP and SVP bags and bottles in the production area.
Definitions:
- DQ: Design Qualification
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
- CSV: Computerized System Validation
Roles:
- Validation Team: Responsible for executing validation activities.
- Quality Assurance: Ensures compliance with regulatory requirements.
- Production Personnel: Operate the Sterile Filtration Skid.
Lifecycle Procedure:
- Design Qualification (DQ): Evaluate design specifications and requirements.
- Installation Qualification (IQ): Verify installation and documentation of the Sterile Filtration Skid.
- Operational Qualification (OQ): Test operational parameters and functionalities.
- Performance Qualification (PQ): Validate performance under actual production conditions.
GDP Controls: Good Documentation Practices must be followed throughout the validation process, ensuring all records are accurate, complete, and traceable.
Acceptance Criteria Governance: Acceptance criteria shall be established based on User Requirements Specification (URS), Annex 1, and Annex 11 compliance.
Calibration/PM Governance: The Sterile Filtration Skid must undergo scheduled calibration and preventive maintenance to ensure operational integrity and compliance.
Change Control Triggers: Any changes to the equipment, processes, or operating procedures must initiate a change control process, including a risk assessment.
Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or whenever significant changes occur that may impact the equipment’s performance.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Certificates
- Change Control Documentation
- Maintenance Records