Spring Intro 2023
28/03/2023
NDMA (and related N-Nitrosamine Compounds) is a carcinogenic compound that was identified as a contaminant or potential contaminant in valsartan and related (sartan) medications in 2018/2019 Led to worldwide batch recalls and product shortages Subsequently identified in some sources of Ranitidine and Metformin May arise from synthetic route, cross-contamination (e.g. recycled solvents), drug product excipients or packaging Full risk analysis required for all synthetic chemistry APIs & Products was mandated in Europe to be completed by March 26 th 2020, subsequently extended to March 2021 If risk is identified, testing to be implemented by September 2022, manufacturing processes must be amended to eliminate risk with variations filed by October 2023 Nitrosamine issue
The Organisation for Professionals in Regulatory Affairs
23
3.2.S.3.2 Impurities (Elemental)
• Existing EU guidance was focussed on ‘metals added during manufacture’
• EU and USP actions postponed awaiting Q3D
• Q3D is MUCH broader and more complex – All elements potentially present in manufacture, API, excipients, equipment, facilities, packaging – Different PDEs based on whether product is oral, parenteral or inhaled – Different elements in risk assessment dependent upon route of administration – When will test data and specification testing be needed – e.g. For Class1’s
The Organisation for Professionals in Regulatory Affairs
24
Made with FlippingBook Annual report maker