This quiz covers the following material :
 Managing Variation
 Statistical Process Control Charts


Quality & Regulatory Relationships
 Food & Drug Administration
The Laws & Code of Federal Regulations
 Good ??? Practices (GXPs)
This quiz is open-book. You may used your notes, texts, other reference materials, and even the internet to answer the questions. However, you may not get assistance from another person. You are expected to complete this quiz on your own.
Have fun, and good luck!
Question 1: 2 pts
Which are the 2 main causes of variation? (select the 2 correct answers)
Common
Minor
Special
Unexpected
Question 2: 1 pts
Which ONE of these 2 causes of variation is inherent in practically all systems?
Common
Question 3: 2 pts
Which cause of variation is most difficult to eliminate?
Common
Why?
Accounts for 85% of variation
Harder to identify common causes
Often requires management input because variation is inherent feature of process

Question 4: 7 pts
For the example statistical control chart shown below, identify each of the parts marked A through G . lower CONTROL limit line axis to plot a particular sample or batch data line upper SPECIFICATION limit line axis to plot measurement for a particular sample or batch target line lower SPECIFICATION limit line
Part A
Part B
Part C
Part D
Part E
Part F
Part G
Question 5: 7 pts
For the different components of the quality and regulations relationship listed below, select the hierarchical level to which each component ties. quality management system organization level
ISO non-government body level
CFRs
FDA
ISO standards government level government level industry level
USC
GMPs/QSRs government level industry level

Question 6: 3 pts
Now that you have an understanding of the FDA regulations impacting the biotechnology industry, why is compliance so challenging?
FDA regulations are written somewhat vague on purpose so that they apply across the industry
The vagueness makes appropriate interpretation of the regulations challenging
The regulations do not tell you specifically what to do to be compliant or how to do it
Question 7: 2 pts
What is 21 CFR (hint: what does this stand for), and what does it have to do with the biotechnology industry?
Title 21 of the Code of Federal Regulations
Are the Food & Drug laws promulgated by the FDA that govern biotechnology companies
Question 8: 1 pts
How do 21 CFR and USC 21 differ?
USC 21 are codified laws put in place by the US government
21 CFR are promulgated by the FDA
Question 9: 13 pts
Indicate which FDA area has primary oversight responsibility for the following: biologics blood components combination products diagnostic test kits dietary supplements drugs
CBER
CBER
None of these
CDRH
CFSAN
CDER enforces FDA regulations Office of Regulatory Affairs food additives given to animals CVM food labeling & nutrition medical devices recalls
CFSAN
CDRH
Office of Regulatory Affairs therapeutic biological products CDER vaccines CBER

Question 10: 1 pts
What is the significance of 21 CFR 820 ?
Medical device GMPs (QSRs)
Question 11: 1 pts
What is the significance of 21 CFR 210 & 211 ?
Pharmaceutical GMPs
Question 12: 1 pts
What is the significance of 21 CFR 606 ?
Biological product GMPs
Question 13: 1 pts
What is the significance of 21 CFR 111 ?
Dietary supplement GMPs
Question 14: 2 pts
What is the significance of 21 CFR 58?
And, to what is it applicable?
GLPs
Nonclinical laboratory studies (i.e. animal studies) that support FDA approval applications
Question 15: 2 pts
You are now "enlightened" because you know about GXPs.
How would you describe, in big picture terms, what GXPs are to those who are not enlightened?
Best practices that define what compliance requires, but does not describe exactly how to do it

Question 16: 2 pts
How does an IND differ from a NDA ?
IND – application to request exemption of approved marketing application for shipping new drug within
US for clinical trials
NDA – application to request approval to sell and market new drug in US
Question 17: 2 pts
How does a 510(k) differ from a PMA ?
510(k) – application to request clearance to sell and market non-exempt Class I or Class II device in US that is substantially equivalent to a legally marketed (predicate) device
PMA – application to request approval to sell and market non-preamendment Class III device in US