What Is Good Manufacturing Practice (GMP)?

Good Manufacturing Practice (GMP) is a system of requirements and controls intended to ensure that medicines are consistently produced and controlled to the quality standards appropriate for their intended use. It covers areas such as trained people, suitable facilities and equipment, approved procedures, documentation, testing, deviations and change control. Digital records can support GMP processes, but software alone does not establish compliance; the manufacturer remains responsible for the quality system and applicable regulations.

Zobacz też: GxP · EBR.