GxP
GxP, or Good x Practice, is a general term encompassing various regulatory guidelines and practices that ensure the quality, safety, and integrity of products in industries regulated by agencies such as the Food and Drug Administration (FDA). In the context of FDA-regulated research, GxP refers to the set of standards and regulations that govern the conduct of research, clinical trials, manufacturing, and distribution of drugs, biologics, medical devices, and other healthcare products. These standards include Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and others, each tailored to specific aspects of the product lifecycle to ensure compliance with regulatory requirements and protection of human participants’ rights, safety, and well-being.
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