EMA publishes GMP non-compliance data
European Medicines Agency (EMA) has published the details of the manufacturers who have not been compliant or those who have violated the GMP guidelines. The EU health agency has published a new version of EudraGMDP recently. This is a database that includes some changes and the publication of statements regarding the non-compliance of GMP standards.
Statement of non-compliance is a documentation that is issued by the inspectors, when they conclude that a particular site under inspection is not compliant. This occurs when the inspectors of regulatory authorities conduct inspection at manufacturing plants and facilities of drug companies.
If a site is complaint with GMP, a GMP certification is issued, whereas when the site is found deficient the non-compliance statement is issued. This document is entered in EudraGMP by the regulatory authorities. From now onwards, the information and such statements of non-compliance as well as positive GMP certificates would be available and publicly accessible. In the year 2013, there were around 34 reports of GMP non-compliance and most of the plants were based in India and China.