Equipment Validation Procedure for Vacuum Transfer System in Solid Dosage Form
Purpose: This SOP outlines the validation process for the Vacuum Transfer System used in the production of solid dosage forms, ensuring compliance with regulatory standards and maintaining product integrity.
Scope: This procedure applies to the validation of the Vacuum Transfer System (Mobile) utilized in the transfer of powders between equipment in the production area.
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 process.
- Quality Assurance: Ensures compliance with regulatory requirements.
- Production Personnel: Operate the equipment and provide feedback on performance.
Lifecycle Procedure:
- Conduct Design Qualification (DQ) to ensure the system meets user requirements.
- Perform Installation Qualification (IQ) to verify that the system is installed correctly.
- Execute Operational Qualification (OQ) to confirm the system operates within specified limits.
- Complete Performance Qualification (PQ) to demonstrate the system performs as intended during actual production.
GDP Controls: Ensure Good Documentation Practices (GDP) are followed throughout the validation process, including proper record-keeping and version control.
Acceptance Criteria Governance: Acceptance criteria will be established based on User Requirements Specification (URS) and aligned with Annex 11 of the relevant guidelines.
Calibration/PM Governance: The Vacuum Transfer System must undergo regular calibration and preventive maintenance as per the established schedule to ensure continued compliance and performance.
Change Control Triggers: Any changes to the system, process, or materials must initiate a change control process to assess impact on validation status.
Revalidation Triggers and Periodic Review: Revalidation is required every 24 months or whenever there is a significant change to the system or process.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Records
- Change Control Documentation
- Periodic Review Records