Q2

Question 1

Which of these are not a regulatory agency?

Pharmaceutical and Medical Safety Bureau
Food and Drug Administration
Therapeutics Products Division
Department of Human Biological Testing
European Medicines Agency

Answer 1

Department of Human Biological Testing

Question 2

Strictness of cGMPS increase as drug product advances through clinical trials to commercial release.

False
True

Answer 2

True

Question 3

What is the umbrella term that we used to speak of any current good practice?

GDP
GCP
CMP
GxP
GLP

Answer 3

GxP

Question 4

Personnel qualifications can be found in 21CFR Part?

210.2
211.22
211.25
210.3
211.28

Answer 4

211.25

Question 5

______________________ consists of any component that is produced with pharmacological activity that would affect the structure or any function of the body of man or other animals.​

Drug Product
Strength
Active Ingredient
Component

Answer 5

Active Ingredient

Question 6

While laws are written and created by Congress, Regulatory laws are passed by Agencies.

False
True

Answer 6

False

Question 7

If you wanted to find more guidances or definitions on cGMPs which CFR title would you find it under?

11
210
32
211
21

Answer 7

21

Question 8

To be qualified to perform functions in a cGMP facility, what are the three things you need?

Answer 8

You need to have the necessary education, training, and experience.

Question 9

In order to stay compliant and perform the job such as supervise, manufacture, packing and holding of the drug product or any other task in good faith there must be an _____________ number of people available.

Answer 9

adequate

Question 10

In your own words, explain the difference between guidelines/guidances and regulation.

Answer 10

Regulations are rules that are mandatory to follow. Guidelines/guidances are recommended but not necessary.