Equipment Validation SOP for Sterile Holding Tank
Purpose: This SOP outlines the validation process for the Sterile Holding Tank used in the production of sterile filtered bulk, ensuring compliance with regulatory requirements and maintaining product integrity.
Scope: This procedure applies to the Sterile Holding Tank utilized in the production area for holding sterile filtered bulk of sterile powders and lyophilized products.
Definitions:
- DQ: Design Qualification
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
- CSV: Computerized System Validation
Roles:
- Validation Team: Responsible for executing the validation activities.
- Quality Assurance: Ensures compliance and reviews validation documentation.
- Production Personnel: Operate and maintain the equipment.
Lifecycle Procedure:
- Design Qualification (DQ): Document user requirements and specifications.
- Installation Qualification (IQ): Verify that the equipment is installed according to specifications.
- Operational Qualification (OQ): Test the equipment under normal operating conditions.
- Performance Qualification (PQ): Confirm the equipment performs as intended with actual product.
GDP Controls: Good Documentation Practices must be followed throughout the validation process, ensuring all records are complete, accurate, and retrievable.
Acceptance Criteria Governance: Refer to User Requirement Specification (URS), Annex 1, and Annex 15 for acceptance criteria related to equipment validation.
Calibration/PM Governance: The Sterile Holding Tank shall undergo calibration and preventive maintenance as per the established schedule. Documentation of all activities must be maintained.
Change Control Triggers: Any changes to the equipment, process, or environment that may affect the validation status must be evaluated through the change control process.
Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or upon significant changes to the equipment or process. Periodic reviews of validation documentation should be conducted to ensure ongoing compliance.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Records
- Change Control Documentation
- Periodic Review Records