Performance Qualification Protocol for Ophthalmic Ointment Manufacturing Vessel

Objective

The objective of this Performance Qualification (PQ) protocol is to demonstrate that the Ophthalmic Ointment Manufacturing Vessel operates consistently and effectively within specified limits to produce sterile/non-sterile ointment bases, ensuring product quality and compliance with regulatory requirements.

Scope

This protocol applies to the Performance Qualification of the Ophthalmic Ointment Manufacturing Vessel used in the production area for the preparation of sterile and non-sterile ointment bases.

Responsibilities

• Validation Team: Responsible for executing and documenting the PQ protocol.
• Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
• Production Personnel: Responsible for operating the equipment as per the validated procedures.

Prerequisites

• Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
• Availability of qualified personnel for conducting the PQ.
• Access to necessary documentation, including URS and Annex 11 acceptance criteria.

Equipment Description

The Ophthalmic Ointment Manufacturing Vessel is a Sigma/Planetary/Vacuum type equipment designed for the preparation of sterile and non-sterile ointment bases. It is equipped with temperature control, vacuum mixing capabilities, and torque measurement systems to ensure optimal mixing conditions.

Test Plan

Detailed Test Cases

Test Case: PQ-001

Objective: To verify that the temperature control system maintains the desired temperature during the mixing process.

Method: Run the equipment at the specified temperature set point and record the temperature at regular intervals. Compare the recorded data against the acceptance criteria.

Expected Result: Temperature should remain within ±2°C of the set point throughout the mixing process.

Test Case: PQ-002

Objective: To ensure that the vacuum level is maintained during operation.

Method: Monitor the vacuum level continuously throughout the mixing process and record the data. Compare against the acceptance criteria.

Expected Result: Vacuum level must remain within the specified range.

Test Case: PQ-003

Objective: To validate that the mixing speed and torque are within specified limits.

Method: Measure the mixing speed and torque during operation and document the results. Compare against acceptance criteria.

Expected Result: Both mixing speed and torque should fall within the specified limits.

Deviations

Any deviations observed during the PQ testing must be documented and reviewed. A root cause analysis will be performed, and corrective actions will be implemented as necessary.

Approvals

This protocol must be reviewed and approved by the Quality Assurance team and relevant stakeholders prior to execution.