|
GMP compliance problems identified during inspections initiated by the EDQM resulted in the suspension of the following CEPs: | Date | Substance name | CEP Number | | 26/10/10 | Metronidazole | CEP 2002-119 | | 26/10/10 | Caffeine | CEP 2005-116 | | 30/09/10 | Pyrazinamide | CEP 2000-036 | | 30/09/10 | Zopiclone | CEP 2001-203 | | 30/09/10 | Isoniazid | CEP 2008-108 | | 08/07/10 | Flunarizine Dihydrochloride | CEP 2004-142 | | 08/07/10 | Loperamide Hydrochloride | CEP 2005-247 | | 08/07/10 | Cinnarizine | CEP 2007-257 |
Due to a failure to comply with a declaration of willingness to be inspected and/or to operate according to EU GMP (e.g. refusal, of inspection, reconstruction/restoration of site(s), to achieve GMP level, and temporary closure):
| Date | Substance name | CEP Number | | 22/10/10 | Rifampicin | CEP 2004-295 | | 09/07/10 | Oxytetracyline Dihydrate | CEP 2004-177 | | 09/07/10 | Oxytetracyline Hydrochloride | CEP 2008-165 | CEP Withdrawals: Due to a failure to fulfill, after a suspension, the requirements of the CEP procedure with regards to updating the application and complying with GMP: | Date | Substance name | CEP Number | | 22/10/10 | Doxycycline Hyclate | CEP 1992-018 | | 22/10/10 | Doxycycline Monohydrate | CEP 1996-064 | | 04/10/10 | Allopurinol | CEP 2004-189 | | 12/07/10 | Ceftriaxone Sodium | CEP 2000-017 | | 12/07/10 | Cefuroxime Sodium | CEP 2004-050 | Again all of the CEP owners are Indian and Chinese companies. Pharmaceutical companies who use these APIs need to verify what consequences this may have for those products already released for the market. In addition, the competent authorities in the different EU Member States will also consult about the consequences. Source: EDQM Webpage www.edqm.eu Previous reports about the suspension of CEPs: GMP News 5 May 2010, GMP News 20 January 2010, GMP News 29 April 2010
|
