Standard Operating Procedure for Validating Drying Ovens in Drug-Eluting Stents

Purpose

This SOP outlines the validation process for the Drying Oven used in the curing and drying of coatings for Drug-Eluting Stents and Coated Devices, ensuring compliance with regulatory requirements and product quality standards.

Scope

This procedure applies to the validation of Drying Ovens utilized in the R&D and Production areas for the manufacturing of Drug-Eluting Stents and Coated Devices.

Definitions

• DQ: Design Qualification
• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• CSV: Computerized System Validation

Roles

• Validation Team: Responsible for the execution of the validation process.
• Quality Assurance: Ensures compliance with regulatory requirements and internal policies.
• Maintenance Team: Responsible for calibration and preventive maintenance of the equipment.

Lifecycle Procedure

1. Conduct Design Qualification (DQ).
2. Perform Installation Qualification (IQ).
3. Execute Operational Qualification (OQ).
4. Complete Performance Qualification (PQ).

Good Documentation Practices (GDP) Controls

All validation activities must be documented following Good Documentation Practices to ensure accuracy, completeness, and traceability.

Acceptance Criteria Governance

Acceptance criteria will be defined in accordance with User Requirements Specification (URS) and will comply with Annex 11 and Annex 15 of the relevant guidelines.

Calibration and Preventive Maintenance Governance

The Drying Oven must be calibrated annually and maintained according to the manufacturer’s specifications and internal guidelines.

Change Control Triggers

Any modifications to the equipment, software, or processes that could impact the validated state must initiate a change control process.

Revalidation Triggers and Periodic Review

Revalidation is required every 12 months or when significant changes occur that may affect the equipment’s performance.

Records/Attachments List

• Design Qualification Report
• Installation Qualification Report
• Operational Qualification Report
• Performance Qualification Report
• Calibration Certificates
• Change Control Records
• Periodic Review Documentation