EDQM发布国际API检查计划最新报告（2017-2024年）
New report on the International API Inspection Programme published
EDQM发布覆盖2017-2024年的国际API检查计划最新报告，该计划现有13个参与机构，旨在促进检查计划与结果信息交换及共同利益生产场地的联合检查。报告显示国际合作加强了原料药生产商的GMP监管，并通过减少重复检查更高效地利用检查资源。
New report on the International API Inspection Programme published
EDQM Strasbourg, France 29/11/2026
Since 2008, the European Directorate for the Quality of Medicines & HealthCare (EDQM) has been actively participating in an international programme to rationalise GMP inspections of active substance (active pharmaceutical ingredient) manufacturers. The programme started as a pilot and evolved to a full programme in 2011. Today the programme has 13 participating authorities.
The aim is to foster co-operation and mutual confidence between participating authorities.
The programme facilitates:
- exchange of information on inspection planning and outcomes;
- organisation of joint inspections for manufacturing sites of common interest.
The latest report covering the period 2017-2024 has now been published and it demonstrates the value of international co-operation in strengthening GMP oversight of active substance manufacturers and more efficient use of inspection resources by reducing duplication of GMP inspections.
As a long-standing participant, the EDQM remains committed to supporting international collaboration aimed at safeguarding the quality of medicines and protecting public health worldwide.
Further information:
来源：EDQM 官方新闻与欧洲药典公告 · edqm.eu