EDQM Announces the Suspension of Further CEPs

As a result of an inspection at a manufacturing site in India and one in China, the EDQM announces the suspension of the following CEPs:

Date Substance name CEP Number
4/01/2010 Zidovudine CEP 2003-276
14/12/09 Carbamazepine CEP 2002-141

In addition the EDQM announces the withdrawal of two CEPs from Chinese manufacturers as a failure to fulfil, after a suspension, the requirements of the CEP procedure with regard to the updating of the application and compliance with GMP. The information is given below:

Date Substance name CEP Number
12/11/09 Doxycycline hyclate CEP 2003-225
12/11/09 Doxycycline monohydrate CEP 2003-226

In our previous GMP News we informed about further suspensions and about the EDQM Guideline that defines the criteria for suspensions and cancellations of CEPs.

The information is used by a number of EU authorities. Previous suspensions showed that some EU authorities took immediate measures after CEP suspensions.

The database of EDQM is accessible to the public. Industry and authority can search for the name and address of the CEP holders.

Source: EDQM webpage

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