Standards

GMP Good Manufacturing Practices

GMP Good Manufacturing Practices

Governing Organization

European Medicines Agency (EMEA)

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Assessment Type

Third party assessed by verified bodies

Memberships

Government Affiliated

Sectors Covered

Pharmaceuticals

Issues Covered

Product Safety, Quality

Description

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. Compliance with these principles and guidelines is mandatory within the European Economic AreaThe 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. Information on GMP inspections co-ordinated by the European Medicines Agency can be found under co-ordination 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.

Sustainability Issues

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