User Requirement Specification (URS) for Purified Water System

1. Introduction
This document outlines the user requirements for the design, installation, and operation of a Purified Water
System (PWS) for pharmaceutical manufacturing. The system must comply with Good Manufacturing
Practices (GMP) and ensure the production of water that meets the quality standards required for
pharmaceutical use.
2. Scope
The PWS will be used to produce, store, and distribute purified water for various pharmaceutical processes,
including the manufacture of active pharmaceutical ingredients (APIs), formulation of dosage forms, and
cleaning of equipment and facilities.
3. System Requirements
3.1 General Requirements
 The system must be designed, installed, and operated in compliance with GMP guidelines.
 The system must be capable of producing purified water that meets the specifications outlined in the
relevant pharmacopoeias (e.g., USP, EP, JP).
 The system must be validated to ensure consistent production of water of the required quality.
3.2 Water Quality Specifications
 The purified water must meet the following quality parameters:
o Conductivity: < 1.3 µS/cm at 25°C
o Total Organic Carbon (TOC): < 500 ppb
o Microbial count: < 100 CFU/mL
o Endotoxins: < 0.25 EU/mL
3.3 System Components
 Pre-treatment Unit: To remove suspended solids, chlorine, and other contaminants.
 Reverse Osmosis (RO) Unit: To remove dissolved salts and organic impurities.
 Electrodeionization (EDI) Unit: To further purify the water by removing ions.
 UV Sterilization Unit: To reduce microbial contamination.
 Storage Tank: To store purified water under controlled conditions.
 Distribution Loop: To distribute purified water to various points of use.
3.4 Materials of Construction
 All components in contact with water must be made of sanitary-grade stainless steel (SS 316L) or
other suitable materials that prevent contamination.
 Piping and fittings must be designed to minimize dead legs and ensure smooth flow.
3.5 Automation, Control and Monitoring
 The system must be equipped with a control panel for monitoring and controlling key parameters (e.g.,
conductivity, TOC, microbial count).
 Automated alarms and shutdown mechanisms must be in place to alert operators of any deviations
from specified parameters.
 Data logging and reporting capabilities must be included for traceability and compliance.
 Control System: The system must be equipped with a Programmable Logic Controller (PLC) to
automate the operation of the water purification process.
 Human-Machine Interface (HMI): An HMI should be provided for operators to monitor and control the
system parameters easily.
 Data Acquisition: The system must have the capability to log data continuously for critical parameters
such as conductivity, TOC, flow rates, and pressure.
 Remote Monitoring: The system should support remote monitoring and control capabilities to allow
operators to access the system from different locations.
 Alarms and Notifications: Automated alarms and notifications must be configured for deviations from
set parameters, equipment failures, and maintenance reminders.
  Integration: The control system should be capable of integrating with other plant systems, such as
Manufacturing Execution Systems (MES) and Laboratory Information Management Systems (LIMS).
3.6 Maintenance and Validation
 The system must be designed for easy maintenance and cleaning.
 Detailed Standard Operating Procedures (SOPs) must be developed for operation, maintenance, and
validation activities.
4. Documentation and Training
 Comprehensive documentation, including design specifications, validation protocols, and maintenance
procedures, must be provided.
 Training programs must be conducted for operators and maintenance personnel to ensure proper
operation and upkeep of the system.
5. Regulatory Compliance
 The system must comply with all relevant regulatory requirements, including those set by the FDA,
EMA, and other applicable authorities.

References
[1] Annex 2 WHO good manufacturing practices: water for pharmaceutical use
[2] VALIDATION OF PURIFIED WATER SYSTEM IN PHARMACEUTICAL INDUSTRY
[3] SOP for Maintenance of Water Purification Systems
[4] What is the correct Maintenance of a Pharmaceutical Water System?
[5] WHO: Water for Pharmaceutical Use - Pharmaguideline
[6] Water Production for Pharmaceutical Manufacturing: Looking Beyond ...
[7] Pharmaceutical Water - gmp-compliance.org
[8] General Chapters: <1231> WATER FOR PHARMACEUTICAL PURPOSES - uspbpep.com
[9] Good manufacturing practices: water for pharmaceutical use