Regulatory Terms Starting With G

4 terms in the G index.

• GMP (Good Manufacturing Practice)

  GMP is the minimum standard for the methods, facilities, and controls used to manufacture a drug, enforced through adulteration: a drug made outside GMP is legally adulterated regardless of whether it passes its release tests.

• Good Clinical Practice (GCP)

  Good Clinical Practice (GCP) is the international standard governing the design, conduct, recording, and reporting of clinical trials in human participants, binding sponsors and investigators to protect participant rights and safety while making trial data verifiable.

• Good Laboratory Practice (GLP)

  Good Laboratory Practice is the FDA quality system at 21 CFR Part 58 governing nonclinical safety studies submitted for research or marketing permits, distinguishing pivotal toxicology work from exploratory laboratory research that carries no such obligations.

• GxP (Good Practice Quality Guidelines)

  GxP is the collective term for the good-practice regulations and guidelines that govern how regulated companies generate, document, and retain data across laboratory, clinical, and manufacturing activities.