Sterile Filtration Skid (LVP) – Equipment Validation SOP

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:

  1. Design Qualification (DQ): Evaluate design specifications and requirements.
  2. Installation Qualification (IQ): Verify installation and documentation of the Sterile Filtration Skid.
  3. Operational Qualification (OQ): Test operational parameters and functionalities.
  4. 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.

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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

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