EU-GMP Chapter

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. Volume 4 in Eudralex (EU Legislation) for "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.

The EU-GMP Chapter App presents Part I (Chapter 1-9) and Part II of Volume 4 in Eudralex with user-friendly e-format. The users can easily reach to each part of the content. This is a convenient self-education and reference for all people working in pharmaceutical and biotech industries.

Keywords :EU-GMP, Good Manufacturing Practice, The European Medicines Agency, EMA, Eudralex, Regulation, Pharmaceutical, Biotechnology