This document outlines the components and requirements of a user requirement specification (URS) for designing new facilities and equipment. A URS ensures that user needs are clearly defined upfront and includes operating requirements, regulatory standards, and specifications that will be used in the design review process. It covers various areas like project description, regulatory requirements, environmental conditions, safety devices, utilities needs, technical specifications, cleaning requirements, performance data, controls, and calibration and maintenance plans. The URS establishes the foundation for design qualification to take place before equipment is constructed so that risks can be identified and addressed early in the design phase.

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Facilitator:-
Dr. Gangadhrappa,
Asst professor,
Dept of pharmaceutics,
JSSCP, Mysuru.
Submitted by:-
Ram Mohan S.R.
1st M pharm
PQA
Jsscp, Mysuru

2. INTRODUCTION
It is the document of
 Planning phase
 Decision making for the equipment
 DQ takes place before the equipment is constructed
 Risk analysis
 Contract agreements
 Subcontracted to suppliers / subcontractors
 Regulatory requirements
 It consists of a people from various disciplines like
 Engineering
 Production
 Quality management
 Project personal
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3. DEFINITION
The documented verification that
the proposed design of the facilities,
system, and equipment is suitable
for the intended purpose
-(EU- GMP Guideline, Anne 15)
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4. User Requirement
Specification (URS)
 It ensures that the user has defined
exactly what is required, by specific
operating and output requirements ,any
critical control requirements and any
internal and regulatory standards, which
may apply.
 All required specification documents
should be approved by appropriate
quality group for GMP compliance, and
used as primary document in design
review process.
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5. COMPONENTS OF URS
 Project description
 Regulatory requirements
 Requirements for Facilities
 Environmental conditions at the planed place of
instillation
 Safety devices
 Utilities
 Technical Dimension and Weights
 Material Quality
 Constructive requirements
 Equipment cleaning
 Performance data in routine operation
 Controls
 Calibration and Maintenance
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6. Project description
 Brief description of the project and the project
objective
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7. Legal requirements
 GMP rules
 Technical facility safety
 Safety at work
 Environmental protection
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8. Requirements for facility or
equipment documentation
 Construction plans
 Diagrams (e.g. R & I, measuring and control
technology,
 electrics, hydraulics/pneumatics, utilities,
plumbing, assembly
 plan)
 Usage procedures
 Maintenance procedures
 Spare parts list
 Conformity declarations
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9. Environmental conditions at the
planned place of installation
 Permissible floor load
 Available utilities and their layout
 Potential influencing factors (e.g. dust, vibrations)
 Clean room requirements
 Room conditions (temperature, air humidity
including regular areas) and finishes
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10. Safety devices
 Electrical and mechanical locks
 Electrical protection classes
 Electrical circuit breakers, safety valves, fault
reports, alarms
 Pressure reduction, non-return valve
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11. Utilities
(e.g. gas, water, compressed air, nitrogen, steam)
 Utilities including connection values and required
performances
 Cleanliness requirements
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12. Technical dimensions and
weights
 Installation dimensions
 Weight of the overall installation
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13. Material quality
 Compatibility certificates for product contact
surfaces
 Certificates for purchased components (e.g.
software)
 Requirements for the surface properties (e.g.
roughness)
 Required surface passivation (inertization)
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14. Constructive requirements
 Utilities supply and filter classes
 Control equipment and systems for plant data
acquisition
 Sampling devices
 Extension possibilities (e.g. additional docking
points and additional interfaces)
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15. Equipment cleaning
 Cleaning procedures
 Cleaning processes (manual, CIP)
 Cleansing agent
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16. Performance data
(process conditions)
in routine operation
 Batch size (maximum, minimum)
 Maximum and minimum process parameters (e.g.
stirring
 speed, pressure, temperature, time)
 Mechanical and electrical performance
requirements
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17. Controls
 Automatic process control
 Requirements for computer validation
 Control and documentation (e.g. screen,
instruments, plant data documentation
paper/electronic)
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18. Calibration, maintenance
 Definition of the type and working
range/sensitivity of measuring
 points requiring calibration
 Maintenance and calibration plan
 Maintenance agreements
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21. LIST OF UTILITIES SUPPLIED
TO THE ROOM
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22. CONCLUSION
Design qualification is the documentation of the
planning phase, including the decision making for the
equipment.
Design qualification takes place before the equipment
Is constructed. The risk analysis is often part of the
design qualification.
The earlier risks can be recorded and evaluated, the
sooner their minimization can be taken into
consideration in the equipment or facility construction
phase.
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23. REFERENCES 23
Thomas Peither, “How to Document Design Qualification”,
LOGFILE No. 8 / August 2011, Maas & Peither AG – GMP
Publishing, Germany.
http://www.gmp-publising.com/

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