Paper details: Risk Assessment Assignment
You are the Quality Manager at an manufacturing site that makes a Biological Product– Bio-X. Bio-X is manufactured by CHO cell growth production, cell separation, Downstream Processing (Protein A, CAT-X, An-X, Viral Filtration), formulation and filling into injectable syringe and packaging.
The product is sold in the EU only.
As part of an assurance of supply program to increase supply of Bio-X, you plan to transfer manufacture of Bio-X to a sister site in your network in Italy
The sister site in your network are going to complete Downstream Processing (Protein A, CAT-X, An-X, Viral Filtration), formulation and filling of the process only – your site will export the cell separated protein to Italy
As part of your assignment provide the following:
They have asked your team you to assist them in this task by performing a risk assessment for this product transfer.
Use Eudralex Volume 4 to identify 5 key areas to evaluate for risks associated with such a transfer and see how they can impact the process. (hint look at chapters 2,3, and 5)
Use any risk assessment tool per ICH Q9 you deem appropriate to evaluate the risks with this project.
• Evaluate 2-3 failure modes/risaqwks for each of the 5 areas identified.
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