Q7 W8

Question 1

_____________ are promptly informed of recall.

Consignees
Directors
FDA
Consumer
QC Personnel

Answer 1

Consignees

Question 2

CFR 21 Part 211 Subpart H Section 211.150 covers:

Distribution Procedures
Warehousing Procedures
Qualified Personnel
Change Process
Change Controls

Answer 2

Distribution Procedures

Question 3

Sales of drug product can be made only to qualified wholesalers.

True
False

Answer 3

False (only licensed wholesalers)

Question 4

The purpose of GDP is to:

Ensure Personnel has education, training, and experience
Describe guidelines for wholesale distribution
Ensuring quality systems are implemented
Bridge gap between Manufacturers and Pharmacists
Provide traceability of all sales and operations

Answer 4

Bridge gap between Manufacturers and Pharmacists

Question 5

Change controls are solely triggered by deviations and CAPAs.

True
False

Answer 5

False

Question 6

CFR 21 Part 820 covers:

Records and Reports
Change Controls
Biologics
Holding and Distribution
Validation Change Request

Answer 6

Change Controls

Question 7

In a product lifecycle, time increases from preclinical phase onward as does effort and formality until product discontinuation.

False
True

Answer 7

True

Question 8

From the link provided: which code covers GDP guidelines?

2001/85/EC
2001/84/EC
2001/83/EC
2013/c 68/01

Answer 8

2001/83/EC

Question 9

Data Security, Complexity with Data exchange in large amounts, accommodations to regulatory changes, ability or inability for infrastructure to scale info, use of data and speed for user friendly databases are all issues significant to _______________________.

Answer 9

serialization

Question 10

What are the three kinds of change controls? Give an example of one of them. Do not describe more than that or points will be taken off. Be secure in your answer.

Answer 10

The three kinds of change controls are major, minor, and critical. An example of a major change control would be changing the incubation time.

Question 11

major change control

Answer 11

affects product process, facility system, or equipment process (ex. incubation time would affect product quality)

Question 12

minor change control

Answer 12

impact some of the process but not the final product characteristics (ex. new equipment affects production time but not product)

Question 13

critical change control

Answer 13

alters product all together and/or impact product process quality (ex. product formulation changes)