Design Qualification in Pharma

-In Design Qualification we provide documented evidence that the premises, supporting systems, utilities and equipment have been designed for their intended purposes and in accordance with the requirements of good manufacturing practices.

     -According to the design qualification Equipment shall be designed as per GMP requirement. 

-The requirements of the user requirements specification should also be verified during the design qualification.

-Design qualification is followed by the FAT (Factory acceptance Test) and SAT (Site acceptance Test) if required.

-Design Qualification Perform prior to purchase.

-Following Check point shall be included in Design Qualification but not limited to

         

          -Basic system design 

          -Selection of Equipment / Accessories

          -Material of construction of all Accessories and Components

          -List of drawings

          -Details of Utilities

          -Safety features