News about GMP/cGMP


EMA: How can a GMP non-compliance statement be lifted?

The European Medicines Agency EMA has clarified its process for lifting a GMP non-compliance statement. The new process is outlined in an update to the question and answer document on GMP of the EMA.

Regarding the question on how a GMP non-compliance statement can be lifted the newly added question/answer 5 in the section on “GMP certificates, non-compliance statements and manufacturing authorisations” says:

In principle, a GMP non-compliance statement can only be lifted following a new inspection by an EU authority that results in the issue of a GMP certificate. In practice, this can present difficulties for manufacturers located in third countries.

For sites located in third countries the GMP non-compliance statement may mean that the site is no longer listed in marketing authorisations or applications and therefore there will be no reason for a new EU inspection. However, EU inspectorates acknowledge that the manufacturer may subsequently take remedial measures to bring the site into an acceptable level of compliance. As there is no intention to convey that the site continues to operate to an unacceptable level of non-compliance and given the absence of a new inspection trigger, the issuing authority will add a clarifying remark where a non-compliance statement appears in EudraGMDP over a prolonged period of time.