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.

Question $8$ options:

Prior approval supplement

None

Risk level $1$

CBE$-30$

Risk Level $2$

Risk Level $3$

$1.$

Change manufacturing site to a different building on the same site

$2.$

Change manufacturing site to another plant site

$3.$

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

$4.$

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

$5.$

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

$6.$

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