GMP Problems cause the Suspension and Withdrawal of further CEPs

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

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