Standard Operating Procedure (SOP) for Water System

Effective Date: [Date]

Version: [Version Number]

Purpose:

This Standard Operating Procedure (SOP) outlines the procedures for the operation and
maintenance of the [Your Organization's Name] Water System to ensure the production of high-
quality water for various purposes, including pharmaceutical manufacturing.

Scope:

This SOP applies to all personnel involved in the operation, maintenance, and monitoring of the
water system at [Your Organization's Location].

Responsibilities:

Water System Operator: Responsible for the day-to-day operation of the water system, routine
checks, and reporting any abnormalities.

Maintenance Technician: Responsible for performing scheduled maintenance, repairs, and

calibration of equipment.

Quality Assurance: Responsible for auditing and ensuring compliance with this SOP and regulatory
requirements.

Procedure:

1. Start-Up Procedure:

1.1. Ensure that all personnel involved in water system operations are properly trained and qualified.

1.2. Verify that all necessary safety equipment and personal protective equipment (PPE) are
available and in good condition.

1.3. Check that all relevant valves are in the closed position.
1.4. Power on the water system in accordance with the manufacturer's instructions.

2. Routine Operation:

2.1. Monitor water system parameters regularly, including but not limited to:

Water flow rates

Temperature

Pressure

Conductivity

pH

2.2. Record all parameter readings at specified intervals in the logbook.

2.3. Inspect all equipment and piping for leaks, corrosion, or any other abnormalities during routine
operation.

2.4. If any deviations or abnormalities are observed, report them immediately to the Water System
Operator and the Quality Assurance department.

3. Preventive Maintenance:

3.1. Schedule and perform routine preventive maintenance on all components of the water system
as per the maintenance schedule provided by the manufacturer.

3.2. Maintain records of all maintenance activities, including date, details of maintenance
performed, and the signature of the Maintenance Technician.

4. Calibration:

4.1. Regularly calibrate all monitoring and control instruments in accordance with the
manufacturer's instructions.
4.2. Document all calibration activities, including date, instrument details, calibration values, and the
signature of the technician performing the calibration.

5. Shutdown Procedure:

5.1. Prior to shutting down the water system, ensure that all valves are closed, and the system is
properly flushed.

5.2. Power off the water system in accordance with the manufacturer's instructions.

6. Record Keeping:

6.1. Maintain accurate and complete records of all water system activities, including operation,
maintenance, calibration, and any deviations.

6.2. Records should be retained for the specified regulatory period.

7. Training:

7.1. Ensure that all personnel involved in water system operation and maintenance receive
appropriate training on this SOP and related procedures.

8. Documentation Review:

8.1. Periodically review and update this SOP as necessary to ensure compliance with current
regulatory requirements and best practices.

9. References:

[List any relevant reference documents, standards, or guidelines.]

10. Definitions:

[Include any specific terminology or abbreviations used in this SOP.]

11. Approval:

[Include a section for signatures and dates of approval by relevant personnel.]