EDQM webinar on strategy for Control of Impurities in CEPs

EDQM conducted a webinar on Control of Impurities in CEPs on 8th July 2021.
Enclosed is the powerpoint of the session. Pg nos 25 to 45 elaborate on Mutagenic Impurities including Nitrosamines.

Module7_How_to_control_impurities.pdf (2.7 MB)


@DAB Thanks for sharing… it’s the first time I see quite a comprehensive step-by-step approach for impurity assessment, the case studies are truly illustrative of what manufacturers have to do.

One of the tools I believe we are lacking as a community is training / step-by-step / case studies on how to adopt or utilize the multiple guides that are out there related to risk assessment on Nitrosamines.

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@DAB Thank you for sharing the good powerpoint you mentioned in other topic. As Naiffer pointed out, the step-by-step approach makes how to assess different types of impurities under multiple guides clear and illustrated. I appreciate your help. And I add the link of this record.

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Thankyou @Naiffer_Host @Yosukemino .
I completely resonate with your feedback on this session. Had the oppurtunity to listen to the SMEs LIVE in this session & interact with them & it has been one of the best one hour comprehensive overview of Imps that I have attended.
Appreciate the efforts put in by EDQM & Ph Eur experts. Dr Ulrich Rose @Ulirose57, it is such a pleasure to listen to you and your team members. Thankyou!

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