In addition to the previously published suspension of 5 CEPs (see GMP News from 29 April 2009) the European Directorate for the Quality of Medicines and HealthCare (EDQM) announced further actions on CEP holders.

The EDQM announces the suspension of the following CEPs as failure to commitments of willingness to be inspected (refusal of inspection, reconstruction/restoration of sites to achieve GMP level, temporary closure of a site...) and/or to operate according to EU GMP: 

Date	Substance Name	CEP Number
26/06/09	Ephedrine Hydrochloride	2004-152
26/06/09	Pseudoephedrine Hydrochloride	2004-153
26/06/09	Rutoside trihydrate	2005-241

The EDQM also gave notice of the withdrawal of the following CEPs - as failure to fullfil, after a suspension, the requirements of the CEP procedure with regards to the updating of the application and compliance with GMP:

Date	Substance Name	CEP Number
03/06/09	Tolbutamide	2003-006
25/05/09	Acetylsalicylic Acid	2000-013

CEP Source: EDQM Webpage www.edqm.eu

As with the previously suspended CEPs these actions are also referring to Chinese and Indian manufacturers only.

User of those APIs/manufacturing sites mentioned above urgently need to evaluate the necessary actions resulting from these announcements.

The EDQM offers a database in which the information on the Certificates of Suitability (CEPs) is available for public. The addresses of the manufacturing sites related to the above mentioned CEPs can be obtained here.