Purpose

This document outlines the procedures for the validation of the Syringe Stoppering Machine used in the production of prefilled syringes and cartridges, ensuring compliance with regulatory requirements and quality standards.

Scope

This SOP applies to the Syringe Stoppering Machine located in the production area and is intended for use by personnel involved in the validation process.

Definitions

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

Roles

The following roles are involved in the validation process:

• Validation Manager: Oversees the validation process.
• Quality Assurance: Ensures compliance with regulatory standards.
• Production Personnel: Operate the equipment during validation.
• Maintenance Personnel: Responsible for equipment maintenance and calibration.

Lifecycle Procedure

1. Conduct Design Qualification (DQ) to ensure specifications meet user requirements.
2. Perform Installation Qualification (IQ) to verify equipment installation.
3. Execute Operational Qualification (OQ) to confirm the equipment operates within specified limits.
4. Complete Performance Qualification (PQ) to ensure the equipment performs as intended under production conditions.

Good Documentation Practices (GDP) Controls

All validation activities must be documented in accordance with GDP to ensure traceability and compliance. Documentation must include:

• Validation protocols
• Execution records
• Final validation reports

Acceptance Criteria Governance

Acceptance criteria will be established based on User Requirements Specification (URS) Annex 11. All criteria must be met for successful validation.

Calibration and Preventive Maintenance Governance

Calibration of the Syringe Stoppering Machine must be performed according to the manufacturer’s specifications and documented as part of the validation process. Preventive maintenance should occur regularly to ensure optimal performance.

Change Control Triggers

Any changes to the equipment, processes, or materials must initiate a change control process to assess the impact on validation status.

Revalidation Triggers and Periodic Review

Revalidation is required every 12 months or upon significant change to the equipment or process. A periodic review will be conducted to ensure ongoing compliance and effectiveness of the validation.

Records and Attachments List

• Validation Protocols
• Validation Reports
• Calibration Records
• Preventive Maintenance Logs
• Change Control Documentation