Standard Operating Procedure for Water Purification System in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish procedures for the operation, maintenance, and monitoring of the water purification system used in the manufacturing of ocular dosage forms to ensure the production of high-quality purified water that meets regulatory standards.

2) Scope

This SOP applies to all water purification systems used within the facility for producing purified water for the manufacturing of ocular dosage forms.

3) Responsibilities

Facility management and maintenance personnel are responsible for the operation, maintenance, and monitoring of the water purification system. Quality assurance personnel are responsible for overseeing compliance with regulatory requirements and standards.

4) Procedure

4.1 Start-up and Shutdown Procedures

1. Ensure all personnel are trained on start-up and shutdown procedures for the water purification system.
2. Check and verify power supply to the water purification unit before starting.
3. Follow manufacturer’s instructions for starting up and shutting down the system.

4.2 Routine Operation

1. Monitor and record operating parameters such as flow rate, pressure, temperature, and water quality regularly.
2. Adjust operational settings as necessary to maintain the specified quality of purified water.
3. Monitor alarm systems and respond promptly to any deviations or abnormalities.

4.3 Filter Replacement and Maintenance

1. Schedule routine filter replacements based on manufacturer’s recommendations and