Standard Operating Procedure for Water System Maintenance

1) Purpose

The purpose of this SOP is to establish the procedures for maintaining water systems to ensure they operate efficiently and comply with regulatory requirements in the pharmaceutical industry.

2) Scope

This SOP applies to all water systems used in the pharmaceutical manufacturing process, including purified water, water for injection (WFI), and other water systems.

3) Responsibilities

The Maintenance and Quality Control Departments are responsible for implementing and adhering to this SOP. All relevant personnel must be trained on the procedures outlined in this document.

4) Procedure

1. Routine Maintenance
   1. Inspect water systems regularly to identify any signs of wear or malfunction.
   2. Perform routine cleaning, sanitization, and servicing as per the manufacturer’s recommendations.
   3. Document all routine maintenance activities, including date, tasks performed, and personnel involved.
2. Preventive Maintenance
   1. Create a preventive maintenance schedule based on manufacturer guidelines and industry standards.
   2. Perform preventive maintenance tasks, such as checking filters, valves, and pumps, and ensuring proper operation of water purification systems.
   3. Document all preventive maintenance activities and update the maintenance schedule as necessary.
3. Corrective Maintenance
   1. Identify and report any issues requiring corrective maintenance immediately.
   2. Perform necessary repairs or replacements to restore water system functionality.
   3. Document all corrective maintenance activities, including date, tasks performed, and personnel involved.
4. Water Quality Monitoring
   1. Monitor water quality parameters, such as microbial counts, conductivity, and total organic carbon (TOC), regularly.
   2. Record monitoring data and review it to ensure compliance with water quality standards.
   3. Take corrective actions if water quality parameters deviate from acceptable limits.
5. Review and Documentation
   1. Review maintenance and water quality monitoring records regularly to identify trends and areas for improvement.
   2. Update maintenance procedures and schedules based on review findings and regulatory updates.

5) Abbreviations, if any

WFI: Water for Injection
TOC: Total Organic Carbon

6) Documents, if any

Maintenance Logs, Water Quality Monitoring Records, Equipment Manuals

7) Reference, if any

Relevant regulatory guidelines such as FDA, EMA, and WHO GMP requirements.

8) SOP Version

Version 1.0