design qualification

1. BY RAM MOHAN S.R. I st M.Pharm . Pharma Quality Assurance, JSSCP - Mysore DESIGN QUALIFICATION DESIGN QUALIFICATION DESIGN QUALIFICATION 1 Submitted to Dr. T.M. Pramod kumar HOD. D epartment 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 2

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) 3

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

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6. ROOM DATA SHEET 6

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8. LIST OF UTILITIES SUPPLIED TO THE ROOM 8

9. REFERENCES Mamohar.A.Potdar; “Pharmaceutical Q uality Assurance” 1/e2010, N irali prakash WWW.Validation-online.net WWW.GMP-Publishing.com 9

10. 10 THANK YOU! THANK YOU! THANK YOU!