FAQs regarding the revisement of CEP Cholesterol HP of CARBOGEN AMCIS
Regulatory affairs
Quality assurance
This is not a recall, but we advise you strongly not to use the product. Since there is no valid CEP, you cannot use the Cholesterol HP in your drug product if you make reference to the CEP in your registration files.
In the end, the MAH has the final decision.
We are in close contact with DISHMAN CARBOGEN AMCIS Ltd. They are primarily responsible for the CAPA plan to be sent to the EDQM. We are involved in drawing up the CAPA plan.
We expect the submission of a CAPA plan within 3 weeks.
After submitting and executing the CAPA plan, a re-inspection of the EQDM is necessary in order to qualify for lifting the removal of the site. Given the current developments with COVID-19, it is very uncertain what the timelines can be.
No, but that is not necessary either. The purchase of wool grease and the starting material is done by CGAM BV. This can guarantee that the wool grease is BSE / TSE free. We can demonstrate the traceability.
FAQs regarding the suspension of CEP Dihydrotachysterol of CARBOGEN AMCIS
Regulatory affairs
We are in close contact with DISHMAN CARBOGEN AMCIS Ltd. They are primarily responsible for the CAPA plan to be sent to the EDQM. We are involved in drawing up the CAPA plan.
We expect the submission of a CAPA plan within 3 weeks.
After submitting and executing the CAPA plan, a re-inspection of the EQDM is necessary in order to qualify for lifting the suspension of the CEP. Given the current developments with COVID-19, it is very uncertain what the timelines can be.
The other CEPs in the name of Carbogen Amcis B.V. remain valid, except for the Cholesterol HP which will be revised (deletion of one of the production locations).
As MAH you are responsible with regard to the substance concerned and any related marketing authorisation or marketing authorisation application.
We will help you as much as possible, for instance with the risk assessment. Therefore we created a document in which we have related the findings to the product. This will help you with the risk assessment. You can find this document below.
Quality assurance
This is not a recall, but we advise you strongly not to use the product. Since there is no valid CEP, you cannot use the Dihydrotachysterol in your drug product if you make reference to the CEP in your registration files.
In the end, the MAH has the final decision.
We are in close contact with DISHMAN CARBOGEN AMCIS Ltd. They are primarily responsible for the CAPA plan to be sent to the EDQM. We are involved in drawing up the CAPA plan.
We expect the submission of a CAPA plan within 3 weeks.
After submitting and executing the CAPA plan, a re-inspection of the EQDM is necessary in order to qualify for lifting the suspension of the CEP. Given the current developments with COVID-19, it is very uncertain what the timelines can be.
Yes, you can download the copy below.