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Match the descriptions to the correct terms. (3 points) Rank the 3 manufactu...

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Match the descriptions to the correct terms.

(3 points) Rank the 3 manufacturing change examples from lowest risk (Level 1) to highest risk (Level 3) based on the risk the change could pose to the product quality.
(3 points) All three situations must be included in the site's Annual Product Review report to the FDA. What additional report, if any, is needed? Select from Pre-market Approval, CBE-30, or no additional report needed.

Report needed for Risk Level 1 Change (in addition to an Annual Report)

Change manufacturing site to another plant site

Change manufacturing site to a different building on the same site

Change manufacturing within a single building, using same equipment, utilities, SOPs

Report needed for Risk Level 2 Change (in addition to an Annual Report)

Report needed for Risk Level 3 Change (in addition to an Annual Report)

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