FACILITY USER REQUIREMENT SPECIFICATION (URS) PROTOCOL

1.0 OBJECTIVE

The objective of this User Requirement Specification (URS) is to define the functional, operational, environmental, and regulatory requirements for the design, construction, and operation of the pharmaceutical manufacturing facility.

This document establishes the minimum requirements for facility layout, cleanroom classification, HVAC systems, utilities, safety systems, and infrastructure to ensure compliance with applicable regulatory guidelines such as WHO GMP, EU GMP, US FDA, and Schedule M.

2.0 SCOPE

This URS applies to the design, engineering, construction, and qualification of the pharmaceutical manufacturing facility, including but not limited to:

• Production areas

• Quality Control laboratories

• Warehouses and storage areas

• Dispensing areas

• Change rooms and airlocks

• Utility areas

• HVAC systems

• Cleanroom environments

• Support areas

The URS will serve as a reference document for engineering design, procurement, installation, and qualification of the facility.

3.0 PURPOSE OF THE FACILITY

The facility shall be designed and constructed to ensure:

• Compliance with current Good Manufacturing Practices (cGMP)

• Prevention of cross-contamination and mix-ups

• Proper personnel and material flow

• Maintenance of required environmental conditions

• Adequate safety and operational efficiency

4.0 REFERENCES

The facility shall comply with the following regulatory and guidance documents:

• WHO Technical Report Series – GMP guidelines

• EU GMP Guidelines

• US FDA 21 CFR Parts 210 & 211

• Indian Schedule M

• ISO 14644 – Cleanroom Standards

• IS / ASHRAE HVAC Standards

• NFPA Fire Safety Standards

5.0 RESPONSIBILITIES

5.1 User Department

• Define operational requirements for facility areas.

• Provide equipment layout and process requirements.

5.2 Engineering Department

• Develop facility design based on URS requirements.

• Ensure compliance with engineering and utility standards.

5.3 Quality Assurance

• Review URS for GMP compliance.

• Approve facility design and qualification documentation.

5.4 EHS Department

• Review environmental, health, and safety requirements.

• Ensure compliance with safety regulations.

6.0 GENERAL FACILITY REQUIREMENTS

The pharmaceutical facility shall be designed to meet the following general requirements:

6.1 Building Structure

• The building shall be constructed using RCC structure with suitable finishing materials.

• Internal surfaces shall be smooth, non-shedding, and easy to clean.

• Walls, floors, and ceilings shall be designed to prevent dust accumulation and microbial contamination.

6.2 Layout Design

The facility layout shall ensure:

• Logical process flow

• Separate personnel and material movement

• Segregation of clean and non-clean areas

• Adequate space for equipment and operations

6.3 Cleanroom Design

Cleanroom areas shall be designed according to ISO 14644 / GMP classification, including:

• Controlled environment conditions

• Airlocks and pressure differentials

• Proper filtration systems

7.0 FINISHES AND MATERIAL OF CONSTRUCTION

The following requirements shall apply to all clean areas:

All surfaces shall be:

• Smooth

• Non-porous

• Crack-free

• Easy to clean and sanitize

8.0 HVAC REQUIREMENTS

The HVAC system shall be designed to maintain the required cleanroom classification and environmental conditions.

Key HVAC Requirements

The system shall include:

• HEPA filtration

• Pressure monitoring

• Air handling units

• Return air systems

9.0 UTILITIES REQUIREMENTS

The facility shall be equipped with the following utilities:

• Purified Water System

• Water for Injection (WFI)

• Compressed Air

• Nitrogen Gas

• Chilled Water

• Steam / Pure Steam

• Vacuum System

• Electrical Supply with UPS backup

Utility systems shall be designed to ensure continuous supply and regulatory compliance.

10.0 ELECTRICAL REQUIREMENTS

Electrical systems shall include:

• Adequate power outlets (single phase / three phase)

• UPS backup for critical equipment

• Cleanroom compatible flush lighting

• Minimum 300–500 lux illumination

Lighting fixtures shall be sealed and flush mounted with the ceiling.

11.0 SAFETY REQUIREMENTS

The facility shall include the following safety systems:

• Fire detection and alarm system

• Fire extinguishers

• Smoke detectors

• Emergency exit routes

• Manual call points

• Public address system

Noise and vibration levels shall be controlled to ensure safe operation.

12.0 COMMUNICATION SYSTEMS

Communication facilities shall include:

• Telephones

• Data network connections

• Digital clocks

• Public address system

These systems shall support operational communication and emergency announcements.

13.0 ENVIRONMENTAL CONTROL

Environmental parameters shall be monitored and controlled including:

• Temperature

• Relative Humidity

• Pressure differential

• Airborne particulate levels

Monitoring devices shall be calibrated and periodically verified.

14.0 ACCESS CONTROL

The facility shall include controlled access through:

• Personnel change rooms

• Airlocks

• Material transfer hatches

• Emergency exits

Personnel shall follow gowning procedures according to area classification.

15.0 DOCUMENTATION AND QUALIFICATION

The facility shall undergo qualification as per validation requirements:

• Design Qualification (DQ)

• Installation Qualification (IQ)

• Operational Qualification (OQ)

• Performance Qualification (PQ)

All qualification activities shall be documented and approved by Quality Assurance.

16.0 APPROVAL

Signature: __________
Date: __________

FACILITY URS PROTOCOL TEMPLATE CONTENTS

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