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Installation qualification, plant design

Most basic validation activities within the cGMP pilot plant are identical to those expected in practice in a manufacturing facility. A validation master plan should be developed that addresses the design specifications and qualification, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) of all major utility systems, process equipment, and computer control systems. Installation and commissioning data should be retained as part of an engineering documentation package. A workable... [Pg.2886]

See other pages where Installation qualification, plant design is mentioned: [Pg.830]    [Pg.11]    [Pg.10]    [Pg.486]    [Pg.223]    [Pg.44]    [Pg.490]    [Pg.271]    [Pg.120]    [Pg.569]    [Pg.200]   
See also in sourсe #XX -- [ Pg.43 ]



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