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Facilities and Equipment Validation

The validation of ne v facilities, systems or equipment is usually accomplished using a four-stage process of design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). [Pg.225]

Design qualification is of most relevance for systems that involve custom-design such as the facilities themselves, vhere it is necessary to demonstrate that the design complies vith GMP requirements. For simpler off-the-shelf equipment it is usually only a matter of selecting the correct equipment for the intended use. [Pg.225]

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. [Pg.225]

Operational qualification involves performing a series of tests to check that all elements of the system are functional across the specified operating range. This usually involves performing challenges at the worst case extreme operating conditions. The process should allow confirmation of final operation, maintenance and calibration procedures. [Pg.225]


Various types of validation generally required in biopharmaceutical manufacturing include process validation, facility and equipment validation, analytical method validation, software validation, cleaning validation and expression system characterization. Combined with other elements of cGMP, including lot release testing, raw material testing, vendor quality certifications, and vendor audits, the quality of product can be consistently assured. [Pg.360]


See other pages where Facilities and Equipment Validation is mentioned: [Pg.225]    [Pg.361]   


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