ABSTRACT

Pharmaceutical manufacturing sites work under a raft of what has become known in the industry as Good Practice regulations. Examples of these regulations include Good Clinical Practice (GCP), associated with clinical trials of medicinal products; Good Distribution Practice (GDP), associated with the distribution of medicinal products after manufacture; Good Manufacturing Practice (GMP), associated with the manufacture of licensed medicinal products; and Good Laboratory Practice (GLP), associated with laboratory operations. Other Good Practice regulations include those for medical devices. The philosophy behind the various Good Practices is broadly the same: to ensure that medicinal products are consistently produced and controlled to the quality, safety and efficacy standards appropriate to their use. Collectively, they are known as the GxPs (because there are so many variants of the three-letter acronyms).