BEC 475/575 GLOBAL REGULATORY AFFAIRS FOR
MEDICAL PRODUCTS MIDTERM EXAM - PART A UPDATED
ACTUAL QUESTIONS AND CORRECT ANSWERS
Question:
1. 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
Question:
2. 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:
Question:
3. 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
Question:
4. Consider the following aseptic filling facilities. Select all
facilities that are considered "multi-purpose facilities".
Answer:
Facility A and E
MEDICAL PRODUCTS MIDTERM EXAM - PART A UPDATED
ACTUAL QUESTIONS AND CORRECT ANSWERS
Question:
1. 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
Question:
2. 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:
Question:
3. 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
Question:
4. Consider the following aseptic filling facilities. Select all
facilities that are considered "multi-purpose facilities".
Answer:
Facility A and E
