Equipment Validation SOP for Stent Coating Machine
Purpose: To establish a standardized approach for the validation of the Stent Coating Machine used in the application of drug-polymer coatings to drug-eluting stents and coated devices.
Scope: This SOP applies to the validation activities for the Stent Coating Machine in the R&D and Production areas, ensuring compliance with regulatory requirements and internal quality standards.
Definitions:
- DQ: Design Qualification
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
- CSV: Computer System Validation
Roles:
- Validation Team: Responsible for planning and executing validation activities.
- Quality Assurance: Ensures compliance with regulatory requirements and reviews validation documentation.
- Operations: Provides operational input and assists in executing validation protocols.
Lifecycle Procedure:
- Design Qualification (DQ): Assess the design specifications against user requirements.
- Installation Qualification (IQ): Verify that the equipment is installed correctly and meets specifications.
- Operational Qualification (OQ): Confirm that the equipment operates according to its intended use under normal operating conditions.
- Performance Qualification (PQ): Validate that the equipment consistently performs as expected with actual product.
GDP Controls: Good Documentation Practices (GDP) must be followed throughout the validation process to ensure traceability and compliance. All documents must be signed and dated by responsible personnel.
Acceptance Criteria Governance: Acceptance criteria must align with User Requirements Specification (URS) and adhere to Annex 11 and Annex 15 of the relevant regulatory guidelines.
Calibration/PM Governance: The Stent Coating Machine must undergo regular calibration and preventive maintenance as per the manufacturer’s recommendations and internal schedules to ensure consistent performance.
Change Control Triggers: Any changes to the equipment, processes, or materials that may impact the validation status must be documented and assessed through the Change Control process.
Revalidation Triggers and Periodic Review: Revalidation is required annually or when significant changes occur. A periodic review of the validation status must be conducted every 12 months to ensure ongoing compliance.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Records
- Change Control Documents
- Periodic Review Records