Quiz 2 - Bio-Link

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Quiz 2

Instructions:

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

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