Performance Qualification Protocol for CCIT System in Ophthalmics

This document outlines the Performance Qualification (PQ) protocol for the Container Closure Integrity Testing (CCIT) System used in the production of sterile eye drops and eye ointments.

Objective: To validate the CCIT System for ensuring container closure integrity in ophthalmic products, confirming compliance with regulatory standards and product safety.

Scope: This protocol applies to the validation of the CCIT System utilized in the QC/Production area for the testing of sterile eye drops and eye ointments.

Responsibilities:

• Validation Team: Responsible for executing the PQ protocol.
• Quality Assurance: Responsible for reviewing and approving the protocol and results.
• Production Team: Responsible for providing necessary equipment and access for validation.

Prerequisites:

• Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
• Availability of necessary documentation (URS Annex11).
• Training of personnel on the use of the CCIT System.

Equipment Description:

The CCIT System is designed for testing the integrity of container closures through methods such as vacuum decay, helium leak detection (HVLD), ensuring the sterility and safety of ophthalmic products.

Detailed Test Cases:

• Test Case 1: Perform vacuum decay test on sample containers.
• Test Case 2: Execute helium leak detection on selected batches.
• Test Case 3: Document and analyze results against acceptance criteria.

Deviations:

Any deviations from the protocol must be documented and justified. A deviation report must be submitted for review and approval.

Approvals:

Prepared by: ____________________ (Validation Team)

Approved by: ____________________ (Quality Assurance)

Data Integrity Checks:

• Ensure all test data is recorded in a validated electronic system.
• Audit trail must be maintained for all test procedures performed.
• Regular backups of data should be taken to prevent loss.