The suspension of CEPs due to non-GMP-compliance in API (active pharmaceutical ingredients) production becomes more and more frequent, and this concerns above all manufacturers from third countries, like India and China. The EMEA has reacted to this situation and issued standard operating procedures for the authorities of the EC member states obliging them to take co-ordinated measures in the case of grave GMP deviations in API manufacture and CEP suspension. We reported about this in our news issue of 22 July.
Not long ago, the following case of a targeted official action after a CEP suspension by the EDQM due to non-GMP-compliance became known:
On 27 August this year, the Dutch supervisory medicines authority MEB (Medicines Evaluation Board) removed the Indian API manufacturer Glochem from all marketing authorisation files in which amlodipine besylate and cetirizine were used as an API. The EDQM had suspended the CEPs for these substances 10 weeks and more than 1 year before, respectively. The marketing authorisation holders were informed immediately. Because of this official measure, at least in the Netherlands, Glochem is no longer an authorised API manufacturer, and the marketing authorisation holders have to establish alternative sources for the APIs in question - if they have not yet done so.
This publication of the Dutch authority on its website is of a new kind. It does not only mention the names of the substances whose CEPs lost their validity; one is also shown a list with the names of the marketing authorisation holders after entering the substance name "Amlodipine" into the search engine on the MEB homepage!
Dr Gerhard Becker
On behalf of the European Compliance Academy (ECA)