Qualification of Equipment and Environments

Qualification of Equipment and Environments


Project or Design Qualification (PQ)

Documented evidence of facilities, support systems, utilities, equipment and processes designed in accordance with GMP (Good Manufacturing Practices)

Installation Qualification (IQ)

A set of operations performed to ensure that facilities (such as equipment, infrastructure, measuring instruments, utilities and manufacturing areas) used in the production processes and / or computer systems are selected and made correctly, in accordance with established requirements.

Operation Qualification (OQ)

Set of operations established under specified conditions, so that the system operates as expected, in all considered operational ranges . All equipment used in the performance of the tests shall be identified and calibrated.

Performance Qualification (PQ)

Control and documentation process of the equipment performance and systems, according to pre-established parameters.

Qualification of Equipment and Environments

Qualification of Equipment and Environments

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