EU revises API certification doc to clarify appeal policy
Detection of manufacturing compliance failings during inspection can lead to suspension or withdrawal of European certification of the pharmaceutical ingredient. Now, the European Directorate for the Quality of Medicines and Healthcare (EDQM) has clarified the appeal process.
“The holder or intended holder of the CEP (certificate of suitability) should ask for a hearing in writing, for a reconsideration of the decision”, says the document. A hearing request should be sent within one month of receiving the EDQM decision and include reasons for the appeal.
Reasons included in the request should show that the EDQM’s decision was questionable and be supported by facts and figures. If a hearing is granted the CEP holder has the opportunity to state its case to a committee.
In the event the appeal is unsuccessful the CEP will be suspended or withdrawn. Suspensions are limited to two years. If a company fails to meet the conditions to lift the suspension the CEP may be withdrawn, after which a new application must be submitted to regain certification.
Manufacturers can choose to voluntarily withdraw a CEP and this is another area clarified in the new policy document. Reasons for submitting a voluntary withdrawal request include wanting to stop manufacturing the product and closure of the production facility.
The request must be made in a letter that explains the reasons for wanting to withdraw the CEP of an active pharmaceutical ingredient (API) or excipient.
EDQM suspensions
In a separate report published on the same day as the revised policy document, the EDQM detailed CEP-related activities that took place during April.
On April 12 EDQM suspended CEPs of four products: naltrexone hydrochloride, buprenorphine, fentanyl, and buprenorphine hydrochloride. The products were all manufactured by India-based Rusan Pharma and were suspended following a manufacturing inspection.
In the first four months of 2011 the EDQM conducted seven inspections, six of which were in Asia. This continues the trend seen in recent years for Asia, and China and India in particular, to account for a large proportion of EDQM inspections.
