BY RAM MOHAN S.R.

Ist M.Pharm. Pharma Quality Assurance,

JSSCP - Mysore

DESIGNQUALIFICATION

DESIGNQUALIFICATION

DESIGNQUALIFICATION

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Submitted to Dr. T.M. Pramod

kumarHOD.

Department of Pharmaceutics, JSSCP - Mysore

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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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DEFINITIONThe 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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COMPONENTS 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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ROOM DATA SHEET

Name of Room

Number of the Room

Normal Human population

Temperature

Humidity

Class of Air

Lighting Intensity

Sound Level

Air Changes per Hour Fresh air intake in cubic feet per hour

Pressure Gradient

List of equipment with Electric load

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• SIZES• FIXTURES• DOORS• WINDOWS • SURFACE FINISH

PHYSICAL DESCRIPTION OF THE

ROOM

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LIST OF UTILITIES SUPPLIED TO THE ROOM

Waters

Compressed air

Vacuum

Steams

Electric powers

Drainage

Fixtures

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REFERENCES

Mamohar.A.Potdar; “Pharmaceutical Quality Assurance” 1/e2010, Nirali prakash

WWW.Validation-online.net

WWW.GMP-Publishing.com

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THANK YOU!THANK YOU!THANK YOU!