Standard Operating Procedure for Lyophilizer SCADA / Control System Validation
Purpose: This SOP outlines the validation process for the Lyophilizer SCADA / Control System to ensure it meets regulatory requirements and product quality standards.
Scope: This procedure applies to the validation of the Lyophilizer SCADA / Control System used in the production of sterile powders and lyophilized products.
Definitions:
- DQ: Design Qualification
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
- CSV: Computer System Validation
Roles:
- Validation Team: Responsible for executing the validation protocol and documentation.
- Quality Assurance: Reviews and approves validation documentation.
- IT Department: Supports the technical aspects of the SCADA system.
Lifecycle Procedure:
- Design Qualification (DQ): Assess the design specifications and requirements.
- Installation Qualification (IQ): Verify that the system is installed according to specifications.
- Operational Qualification (OQ): Test the system’s operational performance against defined criteria.
- Performance Qualification (PQ): Validate the system’s performance in a production environment.
GDP Controls: Ensure Good Documentation Practices are followed throughout the validation process, including proper record-keeping and document control.
Acceptance Criteria Governance: Access to audit trails will be controlled to ensure data integrity. All changes must be tracked and documented.
Calibration/PM Governance: Regular calibration and preventive maintenance must be performed on the SCADA system to ensure consistent performance.
Change Control Triggers: Any changes to the system, software, or process must initiate a change control process, including impact assessment and revalidation if necessary.
Revalidation Triggers and Periodic Review: Revalidation is required upon significant changes to the system or process. Periodic reviews will be conducted at defined intervals to ensure ongoing compliance.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Change Control Records
- Calibration and Maintenance Logs
- Audit Trail Access Logs