EMA – Pilot programme for international cooperation in GMP inspection of manufacturers of sterile medicinal products for human use

The European Medicines Agency (EMA) and its European and international partners launched a pilot project to share information on GMP (Good Manufacturing Practice) inspections of sterile drug manufacturers outside participating countries and to organize joint inspections of manufacturing sites of common interest.

The objective of the pilot phase is to confirm the terms of reference and to promote international cooperation, collaboration and information sharing in GMP inspection planning. Participating regulatory authorities are introduced to the program on a voluntary basis and it is a prerequisite for participation that these agencies have systems to check the GMP status of drug manufacturers whose products are marketed in their territory and imported from third countries.

Important aspects of the project

  • Each participating authority undertakes to share details of its inspection plans and to provide updates on planned inspections and inspection results conducted during the pilot program.

  • The period related to the pilot project is from October 2019 to October 2021.

  • If a participating authority is planning to inspect one place of common interest to another, participating authorities may request scope extension to postpone their own inspection.

  • Project monitoring will be carried out every 6 months, through discussions and adjustments for its evaluation.

Finally, the project consolidates regulatory convergence among participants, a worldwide trend, bringing all the benefits that communication can bring in terms of savings related to enforcement actions that become more effective and focused on real risks

Link: https://bit.ly/2M5itu5

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