Good manufacturing practice (GMP) and good distribution practice (GDP) are related aspects of the quality assurance for medicines in the European Economic Area (EEA). The European Medicines Agency plays an important role in coordinating these activities in collaboration with Member States.
Good manufacturing practice (GMP) is "that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use." The principles and guidelines for GMP are stated in two Directives:
GMP guidelines provide interpretation of these principles and guidelines, supplemented by a series of annexes that modify or augment the detailed guidelines for certain types of product, or provide more specific guidance on a particular topic.
Compliance with these principles and guidelines is mandatory within the EEA.
Information on GMP inspections coordinated by the European Medicines Agency can be found under coordination of GMP inspections.
Good distribution practice (GDP) ensures that the level of quality determined by GMP is maintained throughout the distribution network, so that authorised medicines are distributed to retail pharmacists and others selling medicines general public without any alteration of their properties. The principles of GDP are stated in Directive 92/25/EEC . GDP should be implemented through a quality system operated by the distributor or wholesaler of medicinal products to ensure that:
In addition, the quality system should ensure that the right products are delivered to the right addressee within a satisfactory time period. A tracing system should enable any faulty products to be found and there should be an effective recall procedure.