Q6 W7

Question 1

QA is who designates a batch Approved or Rejected.

False
True

Answer 1

False

Question 2

Date, Time, Lot number, Product, signature are all a part of:

Equipment Logs
Inventory Logs
Facility Logs
Calibration Log
Equipment ID Log

Answer 2

Equipment Logs

Question 3

Batch distribution records must be retained on file __________ after distribution.

3 years
1 year
2 years
6 years
7 years

Answer 3

3 years

Question 4

Annual review of records are also a part of _____________ process:

Post-Market Surveillance
Production and Process Controls
Documentation Controls
Laboratory Records
Records and Reports

Answer 4

?

Question 5

The reworking or repeating of documented steps to ensure batches will conform to standard is known as ______________

Reprocessing
Recall
Salvaging
Stability Testing
Acceptance/Rejection Criteria

Answer 5

Reprocessing

Question 6

Quarantine batches can be reprocessed at a later date

True
False

Answer 6

True

Question 7

Complaints, recalls, and returned goods are responsiblities that ____________should be aware of.

Responsible Officials
FDA
CEO
Director of QC
The Public

Answer 7

Responsible Officials

Question 8

CFR 21 Part 211 Subpart F, Section 211.105 covers:

Equipment Identification
Equipment Logs
Inventory Logs
Laboratory Records
Reprocessing

Answer 8

Equipment Identification

Question 9

Records should be readily ________________ at site where activities transpired, or electronically

Answer 9

retrievable

Question 10

What is the purpose of microbial contamination controls? ALSO give an example of a physical control.

Answer 10

The purpose of microbial contamination controls is to help prevent microbial contamination in the product. An example of a physical control is non-sterile equipment like hair nets, gloves, and PPE.