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The EU's Top Valsartan Lesson: Closely Examine Active Substance Manufacturing Processes

 
• By Joanne S. Eglovitch

EU report on “lessons learnt” from the valsartan crisis calls for tighter GMP controls on API suppliers.

Blood pressure
EU Lessons Learnt Report On Valsartan Crisis Focuses On Supply Chain • Source: Shutterstock

Active pharmaceutical ingredient manufacturers should be required to collect and report information on manufacturing process development in good manufacturing practice (GMP) inspections to ensure that process risks stemming from potential impurities such as nitrosamines are effectively controlled, recommends the European medicines regulatory network.

This recommendation was made in a “lessons learnt” report stemming from the network's 2019 initiative to explore the reasons for the recent valsartan crisis and to recommend steps to prevent such a crisis from occurring again. (Also see "EU Takes Action To Prevent Further Impurities After Sartans" - Generics Bulletin, 7 May, 2019

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