Design Qualification Protocol for CCIT System in Nasal & Otic Products
Document Control:
Document Number: DQ-CCIT-001
Version: 1.0
Date: 2023-10-05
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Objective
The objective of this Design Qualification (DQ) Protocol is to establish and document the requirements for the CCIT System used for Container Closure Integrity Testing of Nasal and Otic Products.
Scope
This protocol applies to the CCIT System (Vacuum Decay/HVLD) used in the Quality Control and Production areas for testing the integrity of container closures for both sterile and non-sterile nasal and otic products.
Responsibilities
Quality Assurance: Review and approve the DQ Protocol.
Validation Team: Execute the DQ Protocol and document results.
Equipment Owner: Ensure the CCIT System is maintained and calibrated.
Prerequisites
1. Equipment Installation Qualification (IQ) must be completed.
2. User Requirement Specification (URS) must be approved.
3. Personnel must be trained on the use of the CCIT System.
Equipment Description
The CCIT System (Vacuum Decay/HVLD) is designed to perform container closure integrity tests by measuring leak rates in packaging systems. The system is critical for ensuring product integrity and compliance with regulatory standards.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Leak Rate Sensitivity Audit Trail | Leak rate must be within specified limits as per URS Annex11 | Test report, Audit trail logs |
Detailed Test Cases
Test Case ID: T1.1
Perform a vacuum decay test on a sample container.
Expected Result: No leaks detected.
Test Case ID: T1.2
Verify audit trail for the test procedure.
Expected Result: Complete and retrievable audit trail.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. Corrective actions must be implemented as necessary.
Approvals
__________________________
Prepared by: [Your Name]
__________________________
Approved by: [Approver’s Name]
Data Integrity Checks
1. Ensure that all test results are stored in a secure, validated electronic system.
2. Regularly review access logs to ensure only authorized personnel can modify test data.
3. Implement backup procedures for all test data to prevent loss.