The European Directorate for the Quality of Medicines & HealthCare (EDQM) is planning to make “real-time remote inspections” a permanent feature of its good manufacturing practice (GMP) inspection program following early positive results from an ongoing pilot.
European Inspectors Spot GMP Deficiencies In India During ‘Virtual Tours’
It Almost Felt Like We Were There, Says EDQM Inspector
A senior inspector at the European Directorate for the Quality of Medicines & HealthCare explained how some “out-of-the-box thinking” was leading to a new approach for inspecting companies.

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A global collaborative inspections pilot reduced the number of individual inspections for participating manufacturing facilities, demonstrating that multiple regulatory authorities can carry out joint inspections using a mix of on-site and remote approaches.
The UK’s medicines regulator is pressing on with clarifying its expectations on decentralized manufacturing of medicines.
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