API Inspections the EDQM experience29 March 2010.ppt

* Dr Florence Benoit-Guyod, March 2010 ?2010 EDQM, Council of Europe, All rights reserved * API Inspections: the EDQM experience29 March 2010 Florence Benoit-Guyod, EDQM Inspector Certification of substances Division, EDQM Overview: The certification procedures and EU regulation framework The EU GMP for APIs The EDQM inspection program Statistics: activity review, compliance trends The Certification Procedure Intended to be applied for the assessment of the quality of pharmaceutical substances with regards to the criteria of the Ph. Eur. monograph(s) It ensures that all possible impurities and contamination can be fully controlled by the requirements of the monograph(s) Additional benefits: centralised assessment for APIs, attractive to applicants and National Competent Authorities Identification of potential divergent practices by national assessors may contribute to more consistent assessment approaches across Europe Inspection Optional part of the Certification Procedure (Article 111 of Directive 2001/83/EC and Article 80 of Directive 2001/82/EC, Compilation of Community Procedures: EMEA/INS/GMP/313538/2006 ) Performed before or after the CEP is granted Aim: to verify the compliance with submitted dossier EU GMP Part II EU GMP Annexes (e.g. Annex 1 / sterile substances) Role of the National Competent Authority 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 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 substa