From Concept to Medicine - A Comprehensive Drug Development Journey

29 – GLP Requirements for Facilities and Equipment (S17E3)


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This episode details the specific GLP standards that govern laboratory facilities and equipment. It covers essential aspects such as environmental controls, instrument calibration, and routine maintenance. The discussion explains how a meticulously controlled lab environment and properly qualified equipment are fundamental to producing valid and reliable test data. The focus in this episdoe is in facilities and equipment.

The episode emphasizes the need for documented procedures and systematic validation. It's essential to ensure that facilities consistently meet all regulatory requirements. It also explores the concepts of design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for equipment. Listeners will understand how these rigorous standards contribute to the overall trustworthiness of scientific findings, impacting product safety and efficacy.

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From Concept to Medicine - A Comprehensive Drug Development JourneyBy Jim Mitchell

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