After process equipment is designed or selected, it should be installed, reviewed, calibrated, challenged, and evaluated to ensure that it is capable of operating within established limits and tolerances as well as throughout all anticipated operating ranges.

Installation and operation qualification studies establish confidence that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use [820.70(g)].

The installation and operation qualification phases of process validation include:

• examining equipment design and supplied documentation;

• determining installation requirements;

• establishing any needed environmental controls and procedures;

• assuring that the work area has sufficient space to perform the processing and associated activities;

• installing the equipment;

• verifying correct installation;

• establishing manufacturing procedures for the monitoring, operation, and control of the equipment including the minimum number of operators;

• determining calibration, cleaning, maintenance, adjustment, and expected repair requirements;

• identifying important elements of the equipment that could affect the output or finished device;

• verifying that the system or subsystem performs as intended throughout all anticipated operating ranges; and

• documenting the above information.