Structure of a URS Document for Pharmaceutical Equipment

A well-structured URS should include the following key sections:

1. Title Page

• Document title (e.g., “User Requirement Specification for [Equipment Name]”)

• Document number and version

• Prepared by / Approved by

• Date

2. Purpose

• A brief statement outlining the purpose of the equipment.

• Why the equipment is needed and how it will support manufacturing or quality operations.

Example:
“This document outlines the user requirements for a tablet coating machine to be used in the oral solid dosage production facility.”

3. Scope

• Defines what the URS covers (equipment, systems, or components).

• Specifies what is included and excluded.

Example:
“This URS covers functional, performance, regulatory, and safety requirements for the tablet coating machine. Installation and utilities are also within the scope.”

4. Overview of the Equipment

• General description of the equipment.

• The role it will play in the manufacturing process.

5. User Requirements

This is the core of the URS and includes all necessary expectations.

A. Functional Requirements

• What the equipment should do.

• Expected operations, controls, and outputs.

Examples:

• Operate in automatic and manual modes.

• Provide real-time temperature monitoring.

B. Performance Requirements

• Quantitative specifications such as speed, capacity, accuracy, etc.

Examples:

• Coating capacity: 10–50 kg/batch.

• Airflow rate: 400–600 m³/h.

C. Regulatory & Compliance Requirements

• Must comply with relevant standards:

  • cGMP (Current Good Manufacturing Practices)

  • 21 CFR Part 11 (if software is involved)

  • EU GMP Annex 11

  • ISO Standards, etc.

D. Safety Requirements

• Safety features to protect operators and the environment.

• Emergency stops, interlocks, shielding, etc.

E. Materials of Construction

• Product contact surfaces (usually stainless steel 316L).

• Non-contact parts (e.g., stainless steel 304).

F. Utilities and Facility Requirements

• Power requirements, water, air, HVAC interface, etc.

G. Cleaning and Maintenance

• CIP/SIP capability (Clean-in-place/Sterilize-in-place)

• Ease of disassembly

• Maintenance access and schedules

H. Control System and Automation

• SCADA, PLC, or HMI requirements

• User access levels

• Data logging, audit trails, alarm management

I. Documentation Requirements

• Equipment manuals

• Maintenance schedules

• Validation protocols (IQ/OQ/PQ support)

J. Installation and Training

• Requirements for vendor-supported installation

• Training for operators and maintenance staff

6. Acceptance Criteria

• Criteria the equipment must meet during Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).

• Tied directly to the URS requirements.

7. Change Control

• Statement that any change to this document must go through a controlled change process.

8. Appendices (if applicable)

• Diagrams

• Process flow

• Layout drawings

• References to related documents (e.g., SOPs, Risk Assessments)

Conclusion

A well-drafted URS ensures that:

• The equipment will meet operational needs.

• Vendors clearly understand expectations.

• Compliance with regulatory and quality standards is built into the equipment selection process.

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