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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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Project description

Brief description of the project and the project

objective

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Legal requirements

GMP rules

Technical facility safety

Safety at work

Environmental protection

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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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Technical dimensions and

weights

Installation dimensions

Weight of the overall installation

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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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Equipment cleaning

Cleaning procedures

Cleaning processes (manual, CIP)

Cleansing agent

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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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LIST OF UTILITIES SUPPLIED

TO THE ROOM

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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/

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THANK YOU!