This document discusses design qualification (DQ), which involves planning, decision making, and risk analysis for new equipment before construction. DQ ensures the proposed design of facilities, systems, and equipment is suitable for the intended purpose. It involves teams from engineering, production, quality management, and project personnel. The DQ documentation covers project description, regulatory requirements, facility and environmental requirements, utilities, technical specifications, materials, cleaning procedures, performance data, controls, calibration, and maintenance.

1. BY
RAM MOHAN S.R.
Ist M.Pharm.
Pharma Quality Assurance,
JSSCP - Mysore
DESIGN
QUALIFICATION
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Submitted to
Dr. T.M. Pramod kumar
HOD.
Department of Pharmaceutics,
JSSCP - Mysore

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. 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 4

5. 5

6. 6

7. 7

8. LIST OF UTILITIES SUPPLIED
TO THE ROOM
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9. REFERENCES
 Mamohar.A.Potdar; “Pharmaceutical Quality Assurance”
1/e2010, Nirali prakash
 WWW.Validation-online.net
 WWW.GMP-Publishing.com
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10. THANK YOU!
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