ASMF: Two API Manufacturing Sites Listed - Only One to Be Registered?

Recommendation

5/6 December 2023

Setting Specifications and Acceptance Criteria - Live Online Training
How to Achieve Regulatory Compliance for APIs, Biological Substances and Drug Products

The Q&A document "QP Declaration" of the CMDh, last revised in December 2018, was updated again in July 2020. Question No. 5, which previously referred to CEPs (Certificates of Suitability of Monographs of the European Pharmacopoeia), has been extended and is now also valid for ASMFs (Active Substance Master Files).

Accordingly, ASMFs that list two different manufacturing sites for the production of an API, but only one of these manufacturing sites is to be registered, require a QP Declaration only for this manufacturing site. In addition, it must be documented that the API is produced exclusively in the same manufacturing site. If the second production site is to be added at a later date, this must be done via a variation and also requires a QP Declaration.

The Q&A document "QP Declaration" including updates can be found on the HMA (Heads of Medicines Agencies) website in the section "CMDh". General information on "How to submit an Active Substance Master File?" can be found here.