BEC 475/575 Global
Regulatory Affairs for
Medical Products Midterm
Exam - Part A fully solved &
updated (graded A+)
If the batch record for steaming a pressure vessel indicates that the
temperature of the vessel must reach 123 +/- 2oC for 35 +/- 5 minutes,
which one set of worst-case conditions should be tested during performance
qualification studies to satisfy the EU regulations? - answer 121 C for 30 min,
125 C for 40 min
A manufacturer wants to implement a critical process change. The PPQ runs
using the change were completed 3 months ago and QA just approved the
last of the validation reports. The Manufacturing group started production
using the new process one month ago. Half of the drug product inventory is
stored in a Distribution Center (DC) in Tennessee and the other half of the
drug product inventory is still in the warehouse of the manufacturing plant.
Which of the following statements are true? - answer
FDA's Center for Drug Evaluation and Research monitors television
advertisements. Which of the following content would they find
objectionable. - answer Drug claim for a dietary supplement, No list of side
effects, Unapproved drug claim
Consider the following aseptic filling facilities. Select all facilities that are
considered "multi-purpose facilities". - answer Facility A and E
Why does the FDA recommend that medical centers doing R&D on new drugs
use disposable equipment during manufacture of Phase 1 investigational
drugs? - answer
Regulatory Affairs for
Medical Products Midterm
Exam - Part A fully solved &
updated (graded A+)
If the batch record for steaming a pressure vessel indicates that the
temperature of the vessel must reach 123 +/- 2oC for 35 +/- 5 minutes,
which one set of worst-case conditions should be tested during performance
qualification studies to satisfy the EU regulations? - answer 121 C for 30 min,
125 C for 40 min
A manufacturer wants to implement a critical process change. The PPQ runs
using the change were completed 3 months ago and QA just approved the
last of the validation reports. The Manufacturing group started production
using the new process one month ago. Half of the drug product inventory is
stored in a Distribution Center (DC) in Tennessee and the other half of the
drug product inventory is still in the warehouse of the manufacturing plant.
Which of the following statements are true? - answer
FDA's Center for Drug Evaluation and Research monitors television
advertisements. Which of the following content would they find
objectionable. - answer Drug claim for a dietary supplement, No list of side
effects, Unapproved drug claim
Consider the following aseptic filling facilities. Select all facilities that are
considered "multi-purpose facilities". - answer Facility A and E
Why does the FDA recommend that medical centers doing R&D on new drugs
use disposable equipment during manufacture of Phase 1 investigational
drugs? - answer
