Q9 W11

Question 1

Your process must be reliable, reproducible, and robust in order to be compliant and validated.

True
False

Answer 1

True

Question 2

__________________ is a deviation measure that charts the behavior process variation from normal behavior pver a fixed period of time.

Quality By Design
Quality Target Product Profile
Critical Quality Attributes
Process Drift
Critical Process Parameters

Answer 2

Process Drift

Question 3

Batch history, distribution, range are specifications regarding:

Computer Validation
Drug Product Critical Quality Attributes
Tableting Steps
Quality Target Product Profile
Process Validation Control Procedures

Answer 3

Drug Product Critical Quality Attributes

Question 4

__________________ establishes performance characteristics and identifies factors that may change results.

Method Validation
Utility Validation
Computer Validation
Equipment Validation
Facility Validation

Answer 4

Method Validation

Question 5

The collection of data and evaulation of data from the process to commercial manufacturing stage while providing scientific evidence of quality is known as_________________________.

Process Validation
Validation Master Plan
Continued Process Verification
Method Validation
Drug Production Process

Answer 5

Process Validation

Question 6

____________________ is the research and development phase where you get to define the process of product manufacturing.

Continued Process Verification
Process Design
Method Validation
Process Validation
Process Qualification

Answer 6

Process Design

Question 7

Major projects, validation issues, and requalification activies are identified as ___________________

Process Qualification Stage
Facility Validation
Process Design Stage
Time based
Project based

Answer 7

Time based

Question 8

During process qualification you want to have more runs commercially than initially.

True
False

Answer 8

False

Question 9

Sensors, air supply, agitators, and the control panel are considered _____________________________

Answer 9

Critical Key Process Parameters/Critical Process Parameters

Question 10

In your own words, explain what makes an operator valid if you can’t technically validate an operator.

Answer 10

An operator can be valid if they have the necessary education, training, and experience.