Qualification
Article 53
1. Before starting the process validation, appropriate qualification of critical equipment and ancillary systems shall be completed. 2. Qualification may be carried out by conducting the following activities, individually or combined: (a) design qualification: documented verification that the proposed design of the facilities, equipment, or systems is suitable for the intended purpose; (b) installation qualification: documented verification that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer’s recommendations and/or user requirements; (c) operational qualification: documented verification that the equipment or systems, as installed or modified, perform as intended throughout the anticipated operating ranges; (d) performance qualification: documented verification that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method and specifications.