EMA: Revised Nitrosamine Q&As
EMA published an updated question-and-answer document on nitrosamine impurities in human medicinal products.
The latest version of this document reflects several changes in the policies and recommendations published to date, such as:
- Higher acceptable intake (AI) limits for nitrosamines impurities, as a result of the full application of the less than lifetime (LTL) approach in ICH M7 for eligible medicines intended for treatments of duration of less than 10 years (see Q&A 24)
- Extension of the CAPA implementation period from 3 to 7 years, under certain conditions (see Q&A 22)
- Inclusion of a new risk factor for nitrosamine formation linked to parenteral products packaged in polymer bags (see Q&A 4)
- Applicability of the approach to establish AI limits for nitrosamines to other N-nitroso compounds (see Q&A 23)
- Update on limits for nitrosamines originating from excipients (see Q&A 10)
Source:
EMA: Nitrosamine impurities: guidance for marketing authorisation holders
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may Also be Interested in the Following Articles
