EDQM implements "Real-Time Remote Inspections"

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

Due to the Corona pandemic and the resulting changes in working conditions, a new type of inspection was needed in addition to the classic inspections carried out on site at the active pharmaceutical ingredient producers' manufacturing facilities and paper-based GMP assessments.

For this purpose, the pilot project for so-called "Real-Time Remote Inspections (RTEMIS)" was created. The pilot phase started in November 2020 and ended successfully at the end of 2021. Numerous European authorities of the EEA (European Economic Area), such as the EDQM (European Directorate for the Quality of Medicines & HealthCare), participated in the pilot phase of the project, and issued GMP certificates during this period after a successfully completed remote inspection. These certificates clearly indicate that the associated inspection was carried out as a "distant assessment" and thus clearly distinguish themselves from previously issued certificates.

According to the EDQM, the components of a successful remote inspection include the following four points:

• The flexibility of the parties involved (manufacturer and authority representatives)
• A sufficient IT infrastructure within the company to be inspected
• Preparatory meetings including connection tests
• Stable IT systems for videoconferencing and secure virtual document exchange system

As the pilot phase has been successfully completed, the EDQM has now included real-time remote inspections as an integral part of the inspection system for monitoring active substance manufacturers and indicates that from January 2022 CEP applicants can be contacted regarding a remote inspection. This will require sufficient IT infrastructure and associated hardware, with all further technical details to be announced in each case during the preparatory phase.

Further information on EDQM's inspection programme and the pilot phase of real-time remote inspections can be found on the EDQM website.