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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
INTRODUCTIONIt 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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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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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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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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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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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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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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Utilities
(e.g. gas, water, compressed air, nitrogen, steam)
Utilities including connection values and required
performances
Cleanliness requirements
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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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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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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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Controls
Automatic process control
Requirements for computer validation
Control and documentation (e.g. screen,
instruments, plant data documentation
paper/electronic)
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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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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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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/