Operational qualification monitoring equipment

Depending on the function and operation of the equipment, utility or system, only installation qualification (IQ) and operational qualification (OQ) may be required, as the correct operation of the equipment, utility or system could be considered to be a sufficient indicator of its performance (refer to Section 11 for IQ, OQ and performance qualification (PQ)). (The equipment, utility and system should then be maintained, monitored and calibrated according to a regular schedule.)... 

For equipment or systems controlled or monitored by a computer-related system, the functional testing cycle approach to computer validation is included and performed as part of the Operational Qualification. Functional testing verifies that the integrated hardware and software program perform in accordance with the functional specifications developed during the requirements phase. 

Process performance qualification typically is conducted during the production of qualification lots using target set points for all process input parameters to demonstrate consistency and reproducibility of input and output parameters [32]. This process consistency is demonstrated by multiple full-scale batches, for example, three-to-five consecutive purification lots from three consecutive fermentation lots, during which yield and product concentration are monitored at each step [14]. A failed lot can occur without resetting the count if it is due to a known assignable cause that is not process-related (e.g., operator error or equipment failure) [33]. The cause of noncompliance must be determined and corrected, the noncompliant product disposition designated, and any corrective actions taken recorded [11]. At... 

Installation qualification involves performing checks to ensure that the correct equipment or system has been installed and/or connected, including all necessary controls, monitors, instrumentation, or ancillary services. These checks should include verification that relevant operator manuals or instructions have been received from the supplier and that any applicable calibration steps have been identified. 

By monitoring the validation status of the applied analytical procedure, for example, with control charts, reliable information on the long-term behavior of the procedure can be obtained and trends can be detected very early. Transferring in this way data to information to knowledge, the analytical system (or the production process) can be adjusted before problems such as OOS results occur (action instead of reaction). In analogy to equipment qualification, a continuous system is proposed design, operational, and performance validation (three Vs). 

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