Equipment Validation Procedure for Air Shower in Solid Dosage Form
Purpose: This SOP outlines the validation process for the Air Shower used in solid dosage form manufacturing to ensure compliance with regulatory requirements and operational effectiveness.
Scope: This procedure applies to the validation of the Air Shower system within the facility, specifically for personnel de-dusting before entry into controlled areas.
Definitions:
- Air Shower: A system designed to remove dust and contaminants from personnel before entering a clean area.
- Validation: The process of establishing documented evidence that a system operates consistently and meets predetermined specifications.
- Criticality: The level of impact an equipment failure may have on product quality; in this case, it is classified as Major.
Roles:
- Validation Team: Responsible for the execution of validation activities and documentation.
- Quality Assurance: Ensures compliance with regulatory standards and reviews validation documentation.
- Maintenance Personnel: Conducts routine maintenance and calibration of the Air Shower.
Lifecycle Procedure:
- Design Qualification (DQ): Assess the design specifications and requirements of the Air Shower.
- Installation Qualification (IQ): Verify that the equipment is installed correctly and meets the manufacturer’s specifications.
- Operational Qualification (OQ): Confirm that the Air Shower operates according to defined parameters.
- Performance Qualification (PQ): Validate the equipment’s performance under actual operating conditions.
GDP Controls: Good Documentation Practices must be adhered to throughout the validation process, ensuring all records are accurate, complete, and retrievable.
Acceptance Criteria Governance: Acceptance criteria will be established based on the User Requirement Specification (URS) to ensure the Air Shower meets all operational and regulatory requirements.
Calibration/PM Governance: The Air Shower shall undergo periodic calibration and preventive maintenance as per the manufacturer’s recommendations, with a documented schedule to ensure continued compliance.
Change Control Triggers: Any modifications to the Air Shower, including software updates, hardware changes, or process alterations, shall initiate a change control process to evaluate the impact on validation status.
Revalidation Triggers and Periodic Review: Revalidation shall occur every 24 months or whenever significant changes are made to the equipment or process. A periodic review will be conducted to assess the need for revalidation.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Certificates
- Maintenance Logs
- User Requirement Specifications (URS)
- Change Control Documentation