Interruptions to the inspection programme of the European Directorate for the Quality of Medicines & HealthCare (EDQM) due to travel restrictions – made necessary by the COVID-19 pandemic – led to the creation of a system of Real-Time Remote Inspections (RTEMIS). This pilot project combines a live video feed, linking inspectors and manufacturing sites of active pharmaceutical ingredients (APIs), and the review of documentary sources, with the objective of monitoring compliance with both Good Manufacturing Practice (GMP) and applications for Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) in manufacturing sites.
EDQM由于COVID-19大流行造成的旅行限制造成检查计划的中断，创建了实时远程检查系统(RTEMIS)。该试点项目结合了实时视频，将检查人员和原料药(API生产场所连接起来，并对文件资料进行审查，目的是监测生产场所是否符合GMP 和是欧洲药典适用性证书（CEP）申请。
The EDQM inspection programme is an integral part of the CEP procedure and is therefore essential to ensuring the availability of good quality medicines. Because the vast majority of inspections takes place in India and China, the EDQM had to find new ways to continue the GMP evaluation of manufacturing sites, complementing the traditional combination of on-site inspections and documentation-based assessment of companies.
EDQM检查计划是CEP程序的一个组成部分，对确保获得高质量药品至关重要。由于绝大多数检查发生在印度和中国，EDQM必须找到新的方法来继续对生产现场进行GMP评估，补充传统的现场检查和基于文件的公司评估相结合的方法。
Technical and administrative solutions meeting strict requirements in terms of information confidentiality and security, inspector safety and of course the effectiveness of the site inspection procedure itself were first examined in detail during a feasibility study, then put into practice in a pilot phase with several manufacturing sites in India. These sites, selected on the basis of their GMP-compliance history and a risk assessment, were invited to participate on a voluntary basis. The objectives of these initial inspections were achieved: a number of minor and major deficiencies were observed and the Corrective and Preventative Action Plans the companies put in place led to a satisfactory degree in GMP conformity on the remotely inspected sites.
在可行性研究期间，首先对满足信息保密和安全、检查员安全以及现场检查程序本身有效性方面的严格要求的技术和行政解决方案进行了详细审查，然后在印度的几个制造基地进行试点。这些地点是根据其gmp符合性历史和风险评估选定的，并在自愿的基础上被邀请参加。这些初步检查的目标已经实现:发现了一些轻微和重大的缺陷，公司实施的纠正和预防行动计划使远程检查场地的GMP符合程度达到了令人满意的程度。
Circumstances and safeguards appropriate for real-time remote inspections are being further examined, but the EDQM considers that real-time remote inspections could be fully integrated into its inspection programme in the future. While this approach cannot replace on-site inspections in terms of value and effectiveness, it does enable inspectors to assess GMP-compliance for companies already having been inspected by the EDQM. Real-time remote inspections could therefore become a third pillar for the supervision of GMP compliance of API manufacturers registered in the EDQM’s CEP scheme.
目前正在进一步审查适合实时远程视察的情况和保障措施，但电子质量管理委员会认为，未来可将实时远程视察充分纳入检查方案。虽然这种方法在价值和有效性方面不能取代现场检查，但它确实可以让检查人员对已经经过EDQM检查的公司的GMP符合性进行评估。因此，实时远程检查可能成为监督CEP计划中注册的原料药生产商GMP符合性的第三个支柱。
