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:
- Design Qualification (DQ): Document requirements and specifications for the PW Storage Tank.
- Installation Qualification (IQ): Verify that the equipment is installed according to specifications.
- Operational Qualification (OQ): Confirm that the equipment operates within specified limits.
- 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.
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