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Interview consisted of a written exam which had a diagram of a tablet manufacturing process flow and a box showing IPC's carried out at compression stage. One question was what kind of IPC's could you have at this stage. Then from your answer you needed to further elaborate on why these IPC's were important to have. Another Question was pick an analytical method of your choice. How would you demonstrate / consider that the analytical method was considered fully validated. Further elaborate on 2 of the criteria you have mentioned above. Q; Describe how you would apply for an MAA in Europe Q: Are there any Quality Aspects of Module 3 which could present a potential risk to public health. Q: Describe what you would find in module 3.2.S, 3.2P. Module 1.
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Pharmaeutcal Assesor

Interviewed at Health Products Regulatory Authority

3.9★
Aug 9, 2018

Interview consisted of a written exam which had a diagram of a tablet manufacturing process flow and a box showing IPC's carried out at compression stage. One question was what kind of IPC's could you have at this stage. Then from your answer you needed to further elaborate on why these IPC's were important to have. Another Question was pick an analytical method of your choice. How would you demonstrate / consider that the analytical method was considered fully validated. Further elaborate on 2 of the criteria you have mentioned above. Q; Describe how you would apply for an MAA in Europe Q: Are there any Quality Aspects of Module 3 which could present a potential risk to public health. Q: Describe what you would find in module 3.2.S, 3.2P. Module 1.

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