News about GMP/cGMP

16.04.2021

Swissmedic: Harmonization of requirements on nitrosamines with EU

Swissmedic: Harmonization of requirements on nitrosamines with EU

On 16 April 2021, Swissmedic announced that it is seeking harmonization with EU regulations regarding the handling of nitrosamine impurities.


Swissmedic refers to the corresponding documents of the EMA:

However, the following exceptions exist:  

  • For medicinal products with biological and biotechnological active substances, Swissmedic only expects further investigations if risk factors exist in excipients or manufacturing conditions. 
     
  • Step 1: In Switzerland, no documents have to be submitted to Swissmedic once Step 1 "Risk Evaluation" has been completed with no risks identified. In the EU, documents must be submitted after this step. This exception also applies to medicinal products that have already been authorized.
     
  • In the case of metformin preparations, the previous regulations remain in place for the time being due to the unresolved reasons for NDMA contamination.   

So far, Swissmedic required the use of a method with a Limit of Quantification (LOQ) of 30 ppb. This requirement does not apply any longer. 


Swissmedic: Potential nitrosamine contamination


 

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