User Requirement Specification (URS) of Equipment

1. Definition

The URS is a document prepared by the end user that clearly defines the functional, operational, and regulatory requirements an equipment must meet before procurement or qualification.
It serves as a reference for vendors, engineers, and QA teams to ensure the selected equipment meets intended use, GMP requirements, and safety standards.

2. Purpose

• To ensure the equipment meets process needs and compliance standards

• To provide a baseline for design, procurement, installation, qualification, and validation

• To avoid purchasing unsuitable equipment

• To form the basis for Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)

3. Typical URS Contents

1. General Information

   • Equipment name, type, model

   • Intended use/process description

2. Capacity & Performance Requirements

   • Operating range (temperature, pressure, speed, volume, etc.)

   • Throughput/output capacity

3. Design & Construction

   • Material of construction (contact & non-contact parts)

   • Surface finish (GMP compliance)

4. Utilities & Services

   • Electrical, water, steam, compressed air requirements

5. Automation & Control

   • PLC/SCADA, alarms, sensors, interlocks

6. Regulatory & Compliance

   • cGMP, FDA, EMA, ICH, 21 CFR Part 11 requirements

7. Safety Features

   • Emergency stop, overload protection, guards

8. Maintenance & Calibration

   • Access for cleaning, maintenance intervals, calibration points

9. Documentation

   • Manuals, drawings, certificates, validation protocols

10. Qualification Requirements

    • IQ/OQ/PQ documentation expectations

4. GMP Perspective

• URS is mandatory in pharmaceutical GMP environments as per WHO, EU GMP Annex 15, and ISPE guidelines.

• It ensures traceability from user needs to final qualification.

5. Example

For an HPLC system URS:

• Detection wavelength range

• Pump flow rate accuracy

• Column oven temperature control

• Data integrity compliance.