Performance Qualification (PQ) Protocol for Leak Test Machine

Objective

The objective of this Performance Qualification (PQ) Protocol is to verify the leak detection sensitivity of the Leak Test Machine ensuring the integrity of container closures for Nasal and Otic products.

Scope

This protocol applies to the Leak Test Machine used in the Production/QC area for both sterile and non-sterile Nasal and Otic products.

Responsibilities

The following personnel are responsible for the execution and oversight of this PQ:

• Validation Manager: Overall responsibility for validation activities.
• Quality Control Personnel: Execution of the test plan.
• Maintenance Personnel: Equipment calibration and maintenance.

Prerequisites

Prior to executing this PQ, the following must be completed:

• Installation Qualification (IQ) must be completed and approved.
• Operational Qualification (OQ) must be completed and approved.
• All personnel must be trained on the equipment and procedures.

Equipment Description

The Leak Test Machine is designed to assess the integrity of container closures by detecting leaks in various packaging formats used for Nasal and Otic products. The machine is equipped with an audit trail feature to ensure data integrity.

Test Plan

Detailed Test Cases

Each test case will be executed as follows:

Test Case: PQ-001-01

Procedure: Conduct the leak detection sensitivity test using standard test containers.

Acceptance Criteria: All test containers must demonstrate no leaks as per the defined limits in URS Annex 11.

Evidence: Documented results and machine logs.

Test Case: PQ-001-02

Procedure: Review the audit trail generated during testing.

Acceptance Criteria: The audit trail must show continuous data capture without any interruptions.

Evidence: Audit trail report documentation.

Deviations

Any deviations from the protocol must be documented and approved by the Validation Manager. A root cause analysis may be required for any significant deviations.

Approvals

All sections of this protocol must be reviewed and approved by the following individuals:

• Validation Manager: ____________________ Date: __________
• Quality Control Manager: ____________________ Date: __________

Data Integrity Checks

As CSV is required, the following data integrity checks will be implemented:

• Verification of data entry accuracy during testing.
• Regular backup of audit trail data.
• Periodic review of equipment logs to ensure compliance with data integrity standards.