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:

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:

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