Whenever a product is manufactured outside of the European Union, I wanted to ask if it is still necessary to have the batch testing and the release site located in Europe in order to distribute medicine.
The answer to your question is yes. In both cases, if the site has never been inspected by the European authorities, it will need to be certified for GMP through an on-site inspection. This inspection is typically organized by the competent authority responsible for evaluating the product dossier, and it will automatically trigger any new inspection of the site. If a GMP certificate is not available for such a site, the competent authorities will limit their inspection to the premises, equipment, and any manufacturing activities related to the product under evaluation. In other words, they will focus on the product listed in the submitted dossier. After a satisfactory inspection by the competent authority and the issuance of a GMP certificate, the site would be allowed to produce the product for the EU. Usually, this certificate remains valid for three years, after which the competent authority will reinspect the site to confirm its compliance status and renew the GMP certificate. In some cases, competent authorities may decide to adjust the inspection frequency based on certain issues or forecasted inspections that may occur while the product is on the market. This decision is typically based on a risk assessment of the site.
What documents are necessary to apply for a new GMP inspection for a site? What kind of dossier documents are required?
One way to initiate a new GMP inspection is by submitting a product dossier, which would trigger the inspection process. Another approach is to request a new GMP inspection directly, even without a dossier. In such cases, it is essential to include an EU qualified person (QP) audit as part of the application. Nowadays, it is always required to have a QP audit, regardless of whether a dossier is submitted or not. The purpose of the QP audit is to ensure that the site is in compliance with the necessary standards before the authority conducts their inspection.