Standard Operating Procedure for the Validation of Sanitary Transfer Pump in IV Infusions

Purpose: This SOP outlines the validation process for the Sanitary Transfer Pump used in the transfer of bulk solutions in IV infusions, ensuring compliance with regulatory standards and maintaining product quality.

Scope: This procedure applies to the validation of Sanitary Transfer Pumps (Mag Drive/Centrifugal) utilized in the production area for IV infusions (LVP/SVP – Bags/Bottles).

Definitions:

• DQ: Design Qualification
• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• URS: User Requirements Specification

Roles:

• Validation Team: Responsible for conducting validation activities.
• Quality Assurance: Ensures compliance with validation protocols.
• Production Personnel: Operate the equipment and provide input on performance.

Lifecycle Procedure:

1. Design Qualification (DQ): Review and approve the design specifications based on URS.
2. Installation Qualification (IQ): Verify installation and setup of the Sanitary Transfer Pump.
3. Operational Qualification (OQ): Validate the operational parameters of the pump.
4. Performance Qualification (PQ): Confirm the pump’s performance meets user requirements during actual use.

GDP Controls: Good Documentation Practices must be followed throughout the validation process, ensuring all documentation is complete, accurate, and readily available for review.

Acceptance Criteria Governance: Acceptance criteria will be established based on the User Requirements Specification (URS) and must be met during each qualification phase.

Calibration/PM Governance: The Sanitary Transfer Pump must undergo routine calibration and preventive maintenance as per the manufacturer’s recommendations and internal protocols.

Change Control Triggers: Any changes to the equipment, process, or product that may affect the validation status must be assessed through the change control process.

Revalidation Triggers and Periodic Review: Revalidation is required every 24 months or when significant changes occur that may impact the pump’s performance.

Records/Attachments List:

• Validation Protocols
• Validation Reports
• Calibration Certificates
• Change Control Documentation
• Maintenance Logs