Skip to main content Skip to search Skip to main navigation

EMA: 13 New Nitrosamines for Appendix 1

Appendix 1 of EMA’s Questions and Answers on nitrosamine impurities has been updated. This appendix contains acceptable intakes (AIs) established for N-nitrosamines.

13 new nitrosamines have been added.


Source:

EMA: Appendix 1: Acceptable intakes established for N-nitrosamines


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.

Test it now for free

You may also be interested in the following articles:

What are the Core Tasks of Human Resource Management?

What are the Core Tasks of Human Resource Management?

Here's the answer:
Read more
European GMP Regulations: Ongoing Changes and What Lies Ahead

European GMP Regulations: Ongoing Changes and What Lies Ahead

At the 2026 ISPE European Annual Conference in Copenhagen, Brendan Cuddy (EMA) provided a concise update on current European GMP regulatory developments and the work of the GMP/GDP Inspectors Working Group (GMDP IWG).
Read more
EMA: Scientific Guideline on Development and Manufacture of Synthetic Peptides

EMA: Scientific Guideline on Development and Manufacture of Synthetic Peptides

The EMA has published the final version of the scientific guideline „Development and manufacture of synthetic peptides“.
Read more
EU: Strengthening Pharmaceutical Supply Chains and Global Health Resilience

EU: Strengthening Pharmaceutical Supply Chains and Global Health Resilience

The European Commission has published a new communication on reinforcing global health resilience, with a strong focus on resilient pharmaceutical supply chains, expanded manufacturing capacity, and security of supply for critical health products.
Read more
Annex 22: EMA Workshop on AI in GMP

Annex 22: EMA Workshop on AI in GMP

The European Medicines Agency (EMA) will hold a two-day multistakeholder workshop on 30 June and 1 July 2026 to gather expert input for the development of Annex 22 of the EU GMP Guide on the use of artificial intelligence (AI) in medicines manufacturing.
Read more
EU: Commission Implementing Regulation on QM and Conformity Assessment Activities of Notified Bodies

EU: Commission Implementing Regulation on QM and Conformity Assessment Activities of Notified Bodies

Commission Implementing Regulation (EU) 2026/977 of 4 May 2026 further specifies requirements for notified bodies under the MDR and IVDR frameworks and aims to promote a more harmonised implementation across the European Union.
Read more
Previous
Next