EU-GMP Guide

Good manufacturing practice (GMP) is the key part of the quality assurance for medicines in the European Economic Area (EEA). EU-GMP is to ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use in EEA. The European Medicines Agency (EMA) plays an important role in coordinating GMP activities in collaboration with Member States. The EU-GMP principles and guidelines for medicines and investigational medicines for human use are stated in Directive 2003/94/EC.

The EU-GMP Guide App presents Directive 2003/94/EC (EU-GMP) in a user-friendly e-format. The users can easily reach to each section of the Directive. This is a convenient self-education and reference for all people working in pharmaceutical and biotech industries.

Keywords : Directive 2003/94/EC, EU-GMP, Good Manufacturing Practice, The European Medicines Agency, EMA, Regulation, Pharmaceutical, Biotechnology