Module 9 2021

19/03/2021

Major categories of infectivity (WHO Report 2010)

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Category IA: High-Infectivity tissues ● Brain, Spinal cord, Retina, spinal ganglia. Category IB: Lower Infectivity Tissues

● Spleen, Lymph nodes, appendix, Liver, blood, saliva Category IC:Tissues with no detectable infectivity ● Milk, Saliva

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The picture can't be displayed. TSE Risk Assessment Guidance Facility and patient safety is paramount and involves mitigating the risk of TSE for raw materials, components and product contact materials via the Risk Assessment process Remove risk of ADRM and Specified Risk Materials (SRM) from processes as far as possible Ensure Company procedures detail the TSE requirements and are followed Ensure adequate tracing systems are in place and IT solutions are available for storage of certificates (evidence for the Regulatory Agencies) Consistent approach for Regulatory submissions ● How far back to go in terms of Tracing (Research/Development /GMP) ● Transfection of the host cell line forward or further back in Research (In House documents detailing the evidence versus Regulatory submissions/Requirements) ● Primary, Secondary and Tertiary raw materials – Recombinant Insulin as an example – Media used to generate recombinant insulin may contain supplements – Processing of insulin (i.e. cleavage may involve animal derived enzymes) Regulatory requirements and expectations are Country specific (Germany, France, US, Japan)

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