Q5 W6

Question 1

Yield calculated electronically do not require second person verification.

False
True

Answer 1

False

Question 2

Deviation description, justification, investigation of root causes, CAPAs, and evaluations are all a part of:

Investigation Report
AQL
Batch Record
Nonconformance
Statistical Sampling

Answer 2

Investigation Report

Question 3

______________________was made to specify the acceptable positions of the spray nozzles on the spray arm.

Equipment Master File
Master Batch Record
Deviation Report Form
SOP
Executed Batch Record

Answer 3

Equipment Master File

Question 4

Theoretical and expected yields are to be included in:

Master Batch Record
Executed Batch Record
SOP
Batch Record
Conclusion of Process

Answer 4

Master Batch Record

Question 5

AQL stands for:

Acceptable Quality Limit
Acceptable Quantity Limit
Acceptable Quality List
Acceptable Quantity Level
Assurance Quality Limit

Answer 5

Acceptable Quality Limit

Question 6

The weight of a in-process material removed from a reactor was 1.2 kg greater than the weight of materials charged because…

Condense toluene increased vent pressure
Calculations were off
Verifier wasn’t paying attention
Scale calibration was off
Disharged material Toluene was not accounted for in the process

Answer 6

Condense toluene increased vent pressure

Question 7

If a result falls outside of established acceptance criteria or set specifications then this is called:

Out of specification
Deviation
Investigation
Nonconformance
Defect

Answer 7

Out of specification

Question 8

Which of these is considered a Major defect?

Low tablet count
Wrong lot number
Crooked label
Wrong tablets
Too many tablets per blister

Answer 8

Low tablet count

Question 9

The total number of defects must be ___________ the limit as defined by AQL ANSI.

Answer 9

less than

Question 10

Please read carefully…Only choose one to answer…DO NOT ANSWER BOTH or YOU WILL NOT GET FULL POINTS.

A. What does CAPA stand for AND what is the purpose of them? OR

B. In your own words, describe how the thermocouple got coated.

Answer 10

CAPA stands for “Corrective Action Preventative Action” or “Corrective And Preventative Action.” They are used when there are deviations and are put into Investigation Reports. The purpose of CAPA is to first correct issues with a current batch and then figure out how to prevent issues in future batches.