Standard Operating Procedure for the Validation of CCIT System in Nasal and Otic Product Manufacturing

Purpose: This SOP outlines the validation process for the Container Closure Integrity Testing (CCIT) System utilized in the manufacturing of nasal and otic products, ensuring compliance with regulatory standards and product integrity.

Scope: This procedure applies to all personnel involved in the validation and operation of the CCIT System in the QC/Production area for both sterile and non-sterile nasal and otic products.

Definitions:

• CCIT: Container Closure Integrity Testing.
• CSV: Computer System Validation.
• DQ: Design Qualification.
• IQ: Installation Qualification.
• OQ: Operational Qualification.
• PQ: Performance Qualification.

Roles:

• Validation Team: Responsible for planning and executing validation activities.
• Quality Assurance: Ensures compliance with regulatory requirements and SOP adherence.
• Production Personnel: Operate equipment and maintain records as per SOP guidelines.

Lifecycle Procedure:

1. Design Qualification (DQ): Verify that the CCIT System meets the User Requirements Specification (URS).
2. Installation Qualification (IQ): Confirm that the system is installed correctly and in accordance with manufacturer specifications.
3. Operational Qualification (OQ): Validate that the system operates within specified limits under normal operating conditions.
4. Performance Qualification (PQ): Demonstrate that the system consistently performs as intended with actual product.

GDP Controls: All activities must comply with Good Documentation Practices to ensure traceability and accountability throughout the validation process.

Acceptance Criteria Governance: Acceptance criteria for the CCIT System will follow the guidelines set forth in the User Requirements Specification (URS) and Annex 11 of the relevant regulatory standards.

Calibration/PM Governance: The CCIT System must undergo regular calibration and preventive maintenance as per the manufacturer’s recommendations and internal procedures to ensure continued accuracy and reliability.

Change Control Triggers: Any modifications to the CCIT System or its operating procedures must be evaluated for impact and managed through the change control process.

Revalidation Triggers and Periodic Review: The CCIT System shall be revalidated every 12 months or whenever significant changes occur that may affect its performance.

Records/Attachments List:

• Validation Protocols and Reports
• Calibration Records
• Change Control Documentation
• Training Records
• Periodic Review Reports