Inspection

News

02 July 2021

Strasbourg, France

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.

由于 COVID-19 大流行而造成的旅行限制，EDQM的检查计划中断，中断的结果是建立了实时远程检查 (RTEMIS) 系统。该试点项目结合了实时视频馈送、将活性药物成分 (API) 的检查员和生产场所联系起来，以及对文件来源的审查，目的是监测生产场所内GMP和CEP申报的遵守情况。

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 检验计划是 CEP 程序的一个组成部分，因此对于确保获得优质药物至关重要。由于绝大多数检查发生在印度和中国，EDQM 必须寻找新的方法来继续对生产场所进行 GMP 评估，以补充现场检查和基于文件的公司评估的传统组合。

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.

技术和行政解决方案在信息机密性和安全性、检查员安全以及现场检查程序本身的有效性方面满足严格要求，首先在可行性研究期间进行了详细检查，然后在多个制造工厂的试点阶段实施 在印度。这些场所是根据其 GMP 合规历史和风险评估选择的，受邀自愿参与。这些初步检查的目标已经实现：观察到了一些次要和主要缺陷，并且公司实施的纠正和预防行动计划在远程检查的现场达到了令人满意的 GMP 合规性。

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.

EDQM正在进一步审查适合实时远程检查的情形和保障措施，但 EDQM 认为实时远程检查可以在未来完全整合到其检查计划中。虽然这种方法在价值和有效性方面不能取代现场检查，但它确实使检查员能够评估已经接受 EDQM 检查的公司的 GMP 合规性。因此，实时远程检查可能成为监督在 EDQM 的 CEP 计划中注册的 API 制造商的 GMP 合规性的第三个支柱。

For more information, see the EDQM’s dedicated web page: “EDQM and real-time remote GMP inspections of API manufacturers during the COVID-19 pandemic: innovation overcoming adversity”.

更多信息，参见EDQM专题网页”EDQM和COVID-19疫情期间API生产商的实时远程GMP检查：创新战胜逆境“。

https://www.edqm.eu/en/edqm-and-real-time-remote-gmp-inspections-api-manufacturers-during-covid-19-pandemic-innovation