Equipment qualification in Pharma

Definition:

-Qualification of equipment provide the document evidence that equipment  is properly installed and working as per the predefined criteria.

-Qualification of the equipment is the part of the validation.

-Equipment need to be appropriately designed,Installed, operated and it shall be performed as per the pre defined criteria. That all activity will be covered in to the qualification.

 

-Before we start the manufacturing process by using the  equipment it need to be qualified. 

-Following the different stage of the qualification:

1. URS (User requirement specification)

2. Design qualification (DQ)

3. Installation qualification (IQ)

4. Operational qualification (OQ)

5. Performance qualification (PQ)

-If equipment is new than only we need to perform the User requirement specification, Design qualification. Now a days FAT (Factory acceptance Test) and SAT (Site acceptance Test) also performed before the installation of the installation of the equipment.

-If you want to replace the equipment from one location to another no need to perform the URS and design qualification.

Design qualification (DQ)

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.

Installation qualification (IQ)

 To ensure that the equipment is installed correctly used in a manufacturing  process

Operational qualification (OQ)

       To ensure that the system perform as per the specified operating ranges

     Performance qualification (PQ)

     Ensure that the equipment or system operates consistently and gives reproducibility within defined specifications and parameters.