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GMP & GDPGood 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

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:

  • Directive 2003/94/EC for medicines and investigational medicines for human use.
  • Directive 91/412/EEC for medicines for veterinary use.

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

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:

  • The medicinal products that they distribute are authorised in accordance with European Union (EU) legislation.
  • Storage conditions are observed at all times, including during transportation.
  • Contamination from or of other products is avoided.
  • An adequate turnover of stored medicinal products takes place.
  • Products are stored in appropriately safe and secure areas.

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.