EDQM认证程序及其在中国的现场检查要求.pdf

Understanding Updated EDQM Certification Procedure and First Hand Experience With Regards to On-site API Inspections in China CPhI China Conference 27 June 2012 Dr Florence BENOIT-GUYOD, EDQM, Council of Europe Overview • The EU GMP for APIs • International API inspection programme • What’s new ? • Main deficiencies • Statistics: activity review, compliance trends • EDQM communication in China and future outlook Dr Florence Benoit-Guyod © 2012 EDQM, Council of Europe, All rights reserved 2 Responsibility of the marketing authorisation holder (MAH) of the medicine • APIs must be produced according to EU GMP (Directives 2001/83/EC and 2001/82/EC) • It is the responsibility of the manufacturer to ensure EU GMP compliance of the active substance manufacturer • Declaration of the Qualified Person (QP) of the manufacturer in the marketing application (and subsequent variation) Dr Florence Benoit-Guyod © 2012 EDQM, Council of Europe, All rights reserved 3 Role of the National Competent Authority in EU • The Competent Authority may inspect an API manufacturer in order to ensure that the manufacturing authorisation holder of a medicinal product has fulfilled its obligations under Article 46 (f) and/or Article 50 (f) of the below mentioned Directives (Article 111 of Directive 2001/83/EC and Article 80 of Directive 2001/82/EC) • NB: in contrast to medicines, inspections are not carried out systematically Dr Florence Benoit-Guyod © 2012 EDQM, Council of Europe, All rights reserved