Standard Operating Procedure for Water System Maintenance
1) Purpose
The purpose of this SOP is to establish procedures for the maintenance of water systems used in the manufacturing of dental dosage forms to ensure water quality and compliance with regulatory standards.
2) Scope
This SOP applies to all water systems used for manufacturing processes involving dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
The Facilities Management Department is responsible for conducting maintenance of the water system. The Quality Assurance (QA) Department is responsible for verifying compliance with this SOP.
4) Procedure
4.1 Routine Maintenance
4.1.1 Develop a schedule for routine maintenance activities based on manufacturer’s recommendations and regulatory requirements.
4.1.2 Inspect water system components including filters, pipes, valves, and tanks for leaks, corrosion, or contamination.
4.1.3 Clean or replace filters and filter cartridges as per maintenance schedule.
4.2 Disinfection Procedures
4.2.1 Develop and follow procedures for periodic disinfection of the water system.
4.2.2 Use approved disinfectants and sanitizers at specified concentrations and contact times.
4.2.3 Flush and purge the water system after disinfection to remove residual disinfectants.
4.3 Calibration and Testing
4.3.1 Calibrate monitoring and control instruments such as pH meters and conductivity meters as per calibration schedule.
4.3.2 Perform water quality testing including microbial and chemical analysis according to established procedures.
4.4 Emergency Response
4.4.1 Respond promptly to water system failures, leaks, or contamination events.
4.4.2 Document emergency response activities and any corrective actions taken.
4.5 Record Keeping
4.5.1 Maintain records of all water system maintenance activities, including inspections, repairs, disinfections, and testing results.
4.5.2 Document any deviations from maintenance procedures and corrective actions taken.
4.6 Validation and Verification
4.6.1 Validate water system performance through periodic testing and validation activities.
4.6.2 Verify water quality parameters to ensure compliance with specified standards and requirements.
5) Abbreviations, if any
QA – Quality Assurance
pH – Potential of Hydrogen
6) Documents, if any
Water System Maintenance Log
Disinfection Records
Water Quality Test Reports
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
8) SOP Version
Version 1.0