Operational Qualification Protocol for Ophthalmics Coding/Printing Machine

Objective

The objective of this protocol is to validate the operational performance of the Coding/Printing Machine used for printing batch and expiry dates on sterile eye drops and ointments, ensuring compliance with regulatory standards and product quality.

Scope

This protocol applies to the Coding/Printing Machine located in the Packaging/Primary area, specifically for the production of sterile ophthalmic products. It encompasses the validation of print quality verification and audit trail functionalities.

Responsibilities

The validation team is responsible for executing this protocol, documenting results, and reporting any deviations. Quality Assurance will review and approve the final report.

Prerequisites

All personnel involved in the execution of this protocol must be trained in equipment operation and validation procedures. The Coding/Printing Machine must be installed and calibrated as per manufacturer specifications.

Equipment Description

The Coding/Printing Machine is designed to print batch and expiry information on packaging for sterile eye drops and ointments. It is critical to ensure that the printed information is accurate and legible to maintain product integrity.

Test Plan

Detailed Test Cases

Test Case OQ-01: Verify Print Quality

Procedure: Print a series of batch and expiry labels and inspect for clarity and legibility. Measure the dimensions of the printed text.

Acceptance Criteria: All printed labels must be clear and legible, with dimensions conforming to specifications outlined in the URS Annex 11.

Test Case OQ-02: Audit Trail Verification

Procedure: Access the machine’s audit trail to verify that all print jobs are logged accurately with timestamps and operator identification.

Acceptance Criteria: The audit trail must show a complete record of all print jobs performed during the qualification period.

Deviations

Any deviations from the acceptance criteria must be documented and investigated. Corrective actions must be implemented and re-validation performed as necessary.

Approvals

This protocol must be approved by the Quality Assurance department and any other relevant stakeholders before execution.

Data Integrity Checks

During this stage, the following data integrity checks will be performed:

• Verification of user access controls to ensure only authorized personnel can modify print settings.
• Regular backups of audit trail data to prevent loss of information.
• Periodic review of audit logs to confirm compliance with operational standards.