Good manufacturing practice (GMP) is the key part of the quality assurance for medicines in the European Economic Area (EEA). The manufacture of sterile products is subject to special requirements in order to minimize risks of microbiological contamination, and of particulate and pyrogen contamination. Much depends on the skill, training and attitudes of the personnel involved. EU-GMP Annex 1 is the EU GMP guideline for manufacturing sterile medicinal products.
The EU-GMP Annex1 App presents Annex 1 to 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, sterile product, clean room