News about GMP/cGMP

25.06.2020

Nitrosamines: Lessons learnt from sartan medicines

On 23 June 2020, the European medicines regulatory network published the outcome of a lessons learned exercise on the presence of nitrosamines in sartan medicines. This includes recommendations to help reduce the risk of impurities in medicines, and to ensure that regulators are better prepared to manage cases of unexpected impurities. The report is called "Lessons learnt from presence of N-nitrosamine impurities in sartan medicines".

The recommendations include:

  • developing additional guidance on:
    • the roles and responsibilities of companies involved in the manufacture of medicines;
    • controlling impurities;
    • good manufacturing practice (GMP);
    • sampling and testing.
  • improving communication with patients and healthcare professionals;
  • expanding cooperation with international partners;
  • further developing information technology systems.

These recommendations apply to all medicines.


Source:

EMA: Nitrosamin Impurities

 



Comments

No comment has yet been written about this news


Write your comment about this news