News about GMP/cGMP

30.10.2020

EMA: Implementation plan to reduce nitrosamine impurities

On 27 October 2020, the European Medicines Agency (EMA) published an implementation plan to reduce nitrosamine impurities in medicinal products.

Already in June 2020, the recommendations were issued by the EMA as "Lessons learnt" (we reported). The comprehensible implementation plan now provides a time frame for implementing the recommendations. On 17 pages 40 recommendations are presented in a table form. It is clarified:  

  • who is responsible for which implementation as the leading authority/working group   
  • which other parties are involved in the implementation   
  • and how the time frame for implementation will look like.   

The following steps are planned, among others:   

  • Supplementing the EU GMP Guideline Part I, Chapter 7 to clarify how marketing authorisation holders can take full responsibility for product quality throughout the entire life cycle, including that of active ingredients. The GMDP-IWG is working on a Q&A and also a GMP guideline for marketing authorization holders, considering relevant aspects as well. For example, the qualification of suppliers or the transfer of technologies are mentioned here.  
  • Supplementing the ICH Q7 guideline on GMP for active ingredients in order to limit the use of reprocessed material, especially if reprocessing is outsourced to third parties  
  • Preparation of a Q&A and related training materials on ICH Q9 quality risk management to eliminate uncertainties regarding the conduct of risk assessments.  

Source:

EMA: Lessons learnt from presence of N-nitrosamine impurities in sartan medicines



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