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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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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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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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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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/