Standard Operating Procedure for Equipment Validation of Leak Test Machine

This SOP outlines the validation process for the Leak Test Machine utilized in the production of Nasal and Otic Products.

Purpose: To ensure the Leak Test Machine is qualified to verify the integrity of container closures for Nasal and Otic Products, ensuring product safety and compliance.

Scope: This SOP applies to the Leak Test Machine used in the Production and Quality Control (QC) areas for both sterile and non-sterile Nasal and Otic products.

Definitions:

• Leak Test Machine: An instrument used to verify the integrity of container closures.
• Criticality: Indicates the direct impact on product quality.
• CSV: Computerized System Validation.

Roles:

• Validation Team: Responsible for the execution and documentation of validation activities.
• Quality Assurance: Ensures compliance with regulatory requirements and SOPs.
• Production Staff: Operates and maintains the Leak Test Machine.

Lifecycle Procedure:

1. Design Qualification (DQ): Verify that the Leak Test Machine meets user requirements.
2. Installation Qualification (IQ): Confirm proper installation and configuration of the equipment.
3. Operational Qualification (OQ): Ensure the machine operates within specified limits.
4. Performance Qualification (PQ): Validate the machine’s performance under actual operating conditions.

Good Documentation Practices (GDP) Controls:

• All records must be accurate, complete, and legible.
• Data must be recorded in real-time during validation activities.
• All corrections must be documented and initialed.

Acceptance Criteria Governance:

Refer to the User Requirement Specification (URS) and Annex 11 for acceptance criteria related to the Leak Test Machine.

Calibration and Preventive Maintenance (PM) Governance:

• Calibration must be performed annually.
• Preventive maintenance should be conducted as per the manufacturer’s recommendations.

Change Control Triggers:

• Any modification to the equipment or its operating procedures.
• Changes in regulatory requirements affecting the equipment.

Revalidation Triggers and Periodic Review:

• Revalidation is required every 12 months.
• Any significant changes to the process or equipment may trigger revalidation.

Records and Attachments List:

• Validation Protocols and Reports
• Calibration Certificates
• Maintenance Logs
• Change Control Documentation