Standard Operating Procedure for Validation of LVP/SVP Compounding Vessel
Purpose: This SOP outlines the process for validating the LVP/SVP Compounding Vessel used in the preparation of bulk infusion solutions, ensuring compliance with regulatory standards and product quality.
Scope: This procedure applies to the validation of the LVP/SVP Compounding Vessel within the production area, covering all aspects of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Definitions:
- LVP: Large Volume Parenterals
- SVP: Small Volume Parenterals
- CSV: Computerized System Validation
- URS: User Requirements Specification
Roles:
- Validation Team: Responsible for executing the validation activities and ensuring compliance with this SOP.
- Quality Assurance: Oversees validation processes, reviews documentation, and ensures adherence to regulatory requirements.
- Production Personnel: Operate the equipment and provide input for validation activities.
Lifecycle Procedure:
- Conduct User Requirements Specification (URS) development.
- Perform Design Qualification (DQ) to ensure the equipment meets specified requirements.
- Carry out Installation Qualification (IQ) to verify proper installation.
- Execute Operational Qualification (OQ) to confirm equipment operates as intended.
- Complete Performance Qualification (PQ) to validate the equipment’s performance in real-world conditions.
GDP Controls: Good Documentation Practices (GDP) must be followed throughout the validation process, ensuring all records are accurate, complete, and readily accessible.
Acceptance Criteria Governance: Acceptance criteria shall adhere to the guidelines set forth in URS, Annex 11, and Annex 15 of the relevant regulatory standards.
Calibration/PM Governance: The LVP/SVP Compounding Vessel must undergo regular calibration and preventive maintenance as per the established schedule to ensure ongoing compliance and performance.
Change Control Triggers: Any changes to the equipment, processes, or validation protocols must initiate a change control process to assess impact and revalidation needs.
Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or when significant changes occur that may impact the equipment’s performance or compliance.
Records/Attachments List:
- User Requirements Specification (URS)
- Validation Protocols (DQ/IQ/OQ/PQ)
- Calibration and Maintenance Records
- Change Control Documentation
- Revalidation Reports