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