1 回答
EDQM因以下活动获得ISO 9001:2015认证:
评估欧洲药典(CEP)专论适用性证书的申请,管理生产场所和相关经纪人的检查计划;
医药产品上市后监测研究的规划、实施和协调以及相关数据库的管理;
协调拟定和发布与官方控制机构批放行程序有关的指南,用于放行人类免疫药品(血液和疫苗)的批;
管理欧洲药典文本的编写、修订、更正和删减,以及印刷和电子版的出版和发行;
进行实验室研究;
欧洲药典参考标准的建立、生产、储存、提供和监控。
The EDQM is ISO 9001:2015 certified for the following activities:
Evaluation of applications for Certificates of suitability to the monographs of the European Pharmacopoeia (CEP) and management of the inspection programme of manufacturing sites and associated brokers;
Planning, implementation and coordination of post-marketing surveillance studies for medicinal products and management of related databases;
Coordination of the elaboration and issuance of guidelines related to the Official Control Authority Batch Release (OCABR) procedure for the release of batches of human immunological medicinal products (blood and vaccines);
Management of the elaboration, revision, correction and suppression of European Pharmacopoeia texts, their publication in printed and electronic format and their distribution;
Conduct of laboratory studies;
Establishment, manufacturing, storage, provision and monitoring of European Pharmacopoeia reference standards.