The EDQM has released a report listing the top 10 deficiencies observed in new CEP applications for chemical purity assessed in 2023. Among them, one deficiency pertained to absent or deficient risk assessment related to Nitrosamines, which accounted for 4% of all deficiencies.
Refer the guidance for more details.
Top Ten Deficiencies in New Applications for Certificates of Suitability for Chemical Purity.pdf (271.1 KB)
