At Azierta, we are experts in developing turnkey projects to optimize time and resources to capitalize on European business opportunities.
Non-European manufacturing companies facing to the need to become a suitable CMO for Europe, are required to undergo a voluntary GMP inspection from the European authorities in order to obtain the European GMP Certificate. We provide comprehensive support through all the steps of the process.
1) Pre-Audit of the Manufacturing plant
Our experts are in charge of implementing the project both on-site and off-site. The first step starts with a pre-inspection of the manufacturing plant with same time frame and approach as EU inspection. Subsequently an audit summary is provided until a final report is sent. Lastly a follow-up of the CAPA plan is performed until pre-audit closures.
2) EU Inspection Request
Meanwhile, we arrange the necessary documentation to request the European Authority inspection: preparation of the official application and the Site Master File (SMF) according to the EU authorities to which the application is being made.
3) Support during the Audit
Once the inspection date has been agreed upon with the EU authorities, experts of Azierta team will join the client the 2 previous audit days for final preparation and provide support on site through the whole 5-day inspection.
Advantages of the EU GMP Certificate
Once the manufacturing company obtains the EU GMP certificate it becomes a suitable CMO for Europe and for those countries with which the EU has a mutual recognition agreement. Henceforth can be included as a manufacturer in a European Dossier. In addition to the objective, obtaining the EU GMP Certificate entails among other advantages:
Maximise the use of the facilities
Drive up sales, not only in Europe but also worldwide
Companies strengthen their image, they become recognised as an international company in terms of quality
For further information, please visit our website European Market Access Support Services, do not hesitate to contact us in case of any doubt.