The Ph. Eur. Commission proposes to revise the general monograph on Substances for pharmaceutical use (2034). This proposal has been made further to the European Commission referral C(2019)2698 of 2 April 2019 and the review initiated by the European Medicines Agency (EMA) in September 2019 under Article 5(3) of Regulation (EC) No. 726/2004 to provide guidance to marketing authorisation holders on how to avoid the presence of N‑nitrosamine impurities in human medicines.
The text will therefore be revised to include a requirement to perform a risk assessment of the manufacturing process and implement a control strategy for the detection and control of N-nitrosamine impurities in the Production section.
In view of the impact of such a change, the Commission seeks the opinion of users on the proposed application of those requirements to all substances for pharmaceutical use, whether they are:
- active substances (or intermediates, if justified) or excipients;
- substances for human use or for veterinary use;
- produced by chemical synthesis or obtained from natural sources, or produced by extraction from raw materials or fermentation.
The revised general monograph will be published in Pharmeuropa 32.1 for public consultation from January to March 2020. Your valuable comments on the proposed revision would be highly appreciated (How to comment).
In the absence of response, the proposed revision will be considered as acceptable.