Filter Integrity Tester – Equipment Validation SOP

Standard Operating Procedure for Equipment Validation of Filter Integrity Tester

Purpose: This SOP outlines the procedures for the validation of the Filter Integrity Tester used in the production and quality control of prefilled syringes and cartridges to ensure compliance with regulatory requirements and product quality.

Scope: This procedure applies to the validation of the Filter Integrity Tester within the Production and Quality Control areas. It encompasses the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases of validation.

Definitions:

  • Filter Integrity Tester: An instrument used to verify the integrity of filters used in the manufacturing process.
  • DQ: Design Qualification
  • IQ: Installation Qualification
  • OQ: Operational Qualification
  • PQ: Performance Qualification
  • CSV: Computer System Validation

Roles:

  • Validation Team: Responsible for the overall validation process.
  • Quality Assurance: Ensures compliance with regulatory and quality standards.
  • Production Personnel: Operate the Filter Integrity Tester and assist in validation activities.

Lifecycle Procedure:

  1. Conduct Design Qualification (DQ) to ensure the Filter Integrity Tester meets user requirements.
  2. Perform Installation Qualification (IQ) to confirm proper installation.
  3. Execute Operational Qualification (OQ) to validate operational parameters.
  4. Complete Performance Qualification (PQ) to demonstrate reliability in actual use.

GDP Controls: All procedures must adhere to Good Documentation Practices (GDP) to ensure traceability and accountability.

Acceptance Criteria Governance: Acceptance criteria must align with User Requirement Specifications (URS) and Annex 11 of the relevant regulations.

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Calibration/PM Governance: The Filter Integrity Tester must be calibrated and maintained according to the manufacturer’s specifications and internal procedures.

Change Control Triggers: Any modifications to the equipment, software, or procedures must initiate a change control process to assess potential impacts on validation status.

Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or when significant changes occur. A periodic review of the validation status must be conducted annually.

Records/Attachments List:

  • Validation Protocols (DQ, IQ, OQ, PQ)
  • Calibration Records
  • Maintenance Logs
  • Change Control Documentation
  • Periodic Review Reports

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