Module 9 2021

19/03/2021

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GBR assessments

OIE Criteria

Presence of one or more cattle clinically or pre-clinically infected with BSE in a geographical region/country Unlikely but not excluded Likely but not confirmed or confirmed at a lower level Confirmed at a higher level (> 100 cases/1 Million adult cattle per year) Highly unlikely

GBR level

Classification Criteria A

Countries or regions with a negligible BSE risk Countries or regions with a controlled BSE risk Countries or regions with an undetermined BSE risk

I

B

II

III

C

IV

• Category A- New Zealand, USA • Category B- Great Britain

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Examples of TSE assessment for Rawmaterials

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Material

Manufacturing Process Decolorized using bovine charcoal

Risk Assessment/Compliance Carbonization of animal tissues (bone) using temperatures >800 o C Treatment at pH > 13 (NaOH concentration of at least 0.1M) at 60 o C for 1 hour Sourced from category A countries and supported by an EDQM Certificate of Suitability In Compliance with Note for Guidance

Sucrose used as an excipient in Drug Product

Cholesterol used in cell culture media as an additive

Extracted from sheep wool (lanolin)

Foetal Bovine Serum

Extracted from bovine blood

Tallow used in plastics during manufacturing

Hydrolysis at not less than 200 o C for not less than 20 minutes

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