Standard Operating Procedure for Equipment Validation of Sterile Filtration Skid

Purpose: This SOP outlines the validation process for the Sterile Filtration Skid used in the production of prefilled syringes and cartridges, ensuring compliance with regulatory requirements and product quality standards.

Scope: This procedure applies to the Sterile Filtration Skid located in the Production area, utilized for filtering sterile bulk solutions. It encompasses all phases of validation: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Definitions:

• DQ: Design Qualification
• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• CSV: Computer System Validation

Roles:

• Validation Team: Responsible for executing the validation activities.
• Quality Assurance: Ensures compliance with regulatory standards and reviews validation documentation.
• Production Personnel: Operate the Sterile Filtration Skid and provide input during validation.

Lifecycle Procedure:

1. Conduct Design Qualification (DQ) to ensure the equipment meets user requirements.
2. Perform Installation Qualification (IQ) to verify that the equipment is installed correctly.
3. Execute Operational Qualification (OQ) to confirm that the equipment operates as intended.
4. Complete Performance Qualification (PQ) to demonstrate that the equipment consistently produces the desired results.

GDP Controls: Ensure Good Documentation Practices (GDP) are followed throughout the validation process, including accurate record-keeping and documentation of all validation activities.

Acceptance Criteria Governance: Acceptance criteria will be established based on User Requirements Specification (URS) and in accordance with Annex 1 and Annex 11 of the relevant guidelines.

Calibration/PM Governance: The Sterile Filtration Skid must undergo regular calibration and preventive maintenance to ensure continued compliance and performance, as per the established schedule.

Change Control Triggers: Any changes to the equipment, process, or usage must be documented and evaluated for impact on validation status, requiring a re-evaluation of the validation lifecycle.

Revalidation Triggers and Periodic Review: Revalidation of the Sterile Filtration Skid is required annually or upon significant changes, as well as after any deviations affecting the equipment’s performance.

Records/Attachments List:

• Validation Plan
• Validation Protocols (DQ, IQ, OQ, PQ)
• Validation Reports
• Calibration Certificates
• Preventive Maintenance Records
• Change Control Documentation