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 facility-specific requirements.
2. Verify filter integrity and seal before installation.
3. Dispose of used filters according to facility waste management procedures.

4.4 Cleaning and Sanitization

1. Clean external surfaces of the water purification unit regularly using approved cleaning agents and methods.
2. Sanitize internal components of the purification unit as per validated procedures to prevent microbial growth.

4.5 Emergency Procedures

1. Develop and maintain emergency procedures for power failures, equipment malfunctions, or other emergencies affecting the water purification system.
2. Train personnel on emergency response procedures and ensure the availability of backup systems or contingency plans.

4.6 Calibration and Validation

1. Calibrate monitoring instruments used to measure flow rate, pressure, temperature, and water quality.
2. Validate the performance of the water purification system periodically according to regulatory requirements and industry standards.

4.7 Documentation and Records

1. Maintain records of routine operations, maintenance activities, filter replacements, and validation results.
2. Document any deviations from standard procedures and corrective actions taken.

4.8 Training

1. Provide training to personnel involved in the operation, maintenance, and monitoring of the water purification system.
2. Ensure personnel are aware of SOP updates and revisions related to the water purification system.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

1. Water purification system maintenance log
2. Filter replacement schedule
3. Validation reports

7) Reference, if any

GMP Guidelines for Pharmaceutical Manufacturing

8) SOP Version

Version 1.0