PW Storage Tank – Equipment Validation SOP

Equipment Validation Procedure for PW Storage Tank in Utilities

Purpose: To establish a standardized procedure for the validation of the PW Storage Tank used for storing purified water, ensuring compliance with regulatory requirements and maintaining product quality.

Scope: This SOP applies to the PW Storage Tank located in the Utilities area and is applicable to all personnel involved in the validation process.

Definitions:

  • Equipment Validation: A documented process to ensure that equipment operates as intended.
  • PW: Purified Water.
  • Criticality: The importance of the equipment in relation to product quality.

Roles:

  • Validation Team: Responsible for planning and executing validation activities.
  • Quality Assurance: Ensures compliance and reviews validation documentation.
  • Operations: Operates the equipment and provides operational input.

Lifecycle Procedure:

  1. Design Qualification (DQ): Document requirements and specifications for the PW Storage Tank.
  2. Installation Qualification (IQ): Verify that the equipment is installed according to specifications.
  3. Operational Qualification (OQ): Confirm that the equipment operates within specified limits.
  4. Performance Qualification (PQ): Demonstrate that the equipment performs effectively for its intended use.

GDP Controls: Good Documentation Practices must be followed to ensure all validation activities are accurately recorded and traceable.

Acceptance Criteria Governance: Acceptance criteria will align with User Requirement Specifications (URS) and Annex 15 guidelines to ensure compliance and quality.

Calibration/PM Governance: Regular calibration and preventive maintenance (PM) shall be performed in accordance with the established schedule to ensure continued performance and reliability.

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Change Control Triggers: Any changes to the equipment, process, or operating procedures must initiate a change control process to assess the impact on validation status.

Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or whenever there is a significant change to the equipment or process.

Records/Attachments List:

  • Validation Protocols
  • Validation Reports
  • Calibration Records
  • Change Control Documentation
  • Periodic Review Records

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