In case you didn’t have the opportunity to attend the GRx+Biosims 2023 conference or were there and want to revisit the featured panel on nitrosamine impurities, here’s a quick recap and a link to the full Contract Pharma article, authored by Jennifer Leaming, Principal Consultant, Lachman Consultants.
Four presentations were made by FDA representatives on the panel including a review of the new Nitrosamine Drug Substance Related Impurities (NDSRI) guidance published in August of this year. Another presentation detailed where and how NDSRIs can occur and stressed the importance of including these nitrosamine impurities in the risk assessment for all drug substances and drug products. Also outlined was the work that FDA has been doing to determine the possible impacts of using some antioxidants recommended in earlier Nitrosamine guidance.
Industry presenters focused their comments on the challenges that were not adequately addressed with the NDSRI guidance and the opportunities for continued discussion and collaboration among FDA staff and other industry groups. The issues of data prioritization and assessment prioritization remain as challenges to be overcome as well. There were also signs of progress mentioned in a recent FDA letter sent to an applicant with an NDSRI deficiency.
For more details about these and other nitrosamine topics discussed at GRx+Biosims 2023, read the full Contract Pharma article here.
And for help incorporating NDSRIs into your nitrosamine risk assessments or crafting a regulatory strategy to address nitrosamine impurities, click here or contact us at LCS@lachmanconsultants.com.
