Document Control
Document Number: PQ-CCIT-001
Version: 1.0
Effective Date: [Insert Date]
Prepared by: [Insert Name]
Reviewed by: [Insert Name]
Approved by: [Insert Name]
Performance Qualification Protocol for CCIT System in Nasal & Otic Products
Objective
The objective of this Performance Qualification (PQ) protocol is to ensure that the CCIT System (Vacuum Decay/HVLD) is capable of consistently performing container closure integrity tests for nasal and otic products, meeting the defined acceptance criteria.
Scope
This protocol applies to the CCIT System used in the Quality Control (QC) and Production areas for the validation of nasal and otic products, both sterile and non-sterile.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Production Team: Responsible for maintaining the CCIT System and ensuring it is in a validated state.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary materials and equipment for testing.
- Training of personnel on the CCIT System operation.
Equipment Description
The CCIT System (Vacuum Decay/HVLD) is an instrument designed to perform container closure integrity tests by assessing the leak rate sensitivity of containers used for nasal and otic products. It ensures that products maintain sterility and efficacy throughout their shelf life.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Perform vacuum decay test on specified containers. | Leak rate sensitivity as per URS Annex11. | Test results report. |
| PQ-002 | Document audit trail for each test. | Audit trail must be complete and accurate. | Audit trail log. |
Detailed Test Cases
Test Case 1: Vacuum Decay Test
Objective: To determine the leak rate sensitivity of the container closure system.
- Set up the CCIT System as per manufacturer’s instructions.
- Calibrate the system before testing.
- Place the sample containers in the testing chamber.
- Initiate the vacuum decay test.
- Record the leak rate and compare against acceptance criteria.
Test Case 2: Audit Trail Documentation
Objective: To ensure all test results are documented with an accurate audit trail.
- After each test, document the results in the designated log.
- Ensure all entries are time-stamped and signed by the operator.
- Verify the completeness of the log against the executed tests.
Deviations
Any deviations from the protocol must be documented and investigated. A deviation report should include the nature of the deviation, the impact on the test results, and corrective actions taken.
Approvals
This protocol must be approved by the Quality Assurance department prior to execution. All results and deviations must also be reviewed and approved post-testing.
Data Integrity Checks
As CSV is required for this stage, the following data integrity checks will be implemented:
- Verification of data entry accuracy (double entry system).
- Automated checks for data consistency and completeness.
- Regular audits of the data management process.