Q8 W9 Flashcards

1
Q

Computer Validation is similiar to:

Installation Qualification
Method Validation
Operational Qualification
Process Validation
Performance Qualification

A

Installation Qualification

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Which of these are true?

DQ OQ, IQ, PQ, RQ
DQ, IQ, PQ, OQ, RQ
DQ, RQ, IQ, OQ, PQ
DQ, IQ, OQ, PQ, RQ
DQ, PQ, OQ, IQ, RQ

A

DQ, IQ, OQ, PQ, RQ

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

At which stage will you need to circle back and review if an upgrade is necessary?

Installation Qualification
Operational Qualification
Re-Qualification
Performance Qualification
Design Qualification

A

Design Qualification

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

The root cause of the Devonport Incident of 1972 was:

Lack of validation of sterilization protocol
Inadequate equipment maintenance
Contamination of Dextrose IV bottles
Protocol Deviation
Oral communication on autoclaving procedure

A

Lack of validation of sterilization protocol

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Qualification and Process Validation are a part of CFR 21, however are not defined in Part 820.

True
False

A

False

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

ID #, Product and product part description, function, technical and software requirements can all be found on:

Internal User Document
Design Drawings
Instructions Manual
User requirements document
Vendor Information Sheet

A

Vendor Information Sheet

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Elisa PCR, Karl Fischer, Electron Microscopy, Western Blot are all analytical examples used in:

Computer Validation
Method Validation
Design Qualification
Performance Qualification
Operational Qualification

A

Method Validation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

________________ is the process of verifying and assuring instruments are operating properly and are cGMP compliant after a certain period of time.

Requalification
Operational Qualification
Installation Qualification
Design Qualification
Performance Qualification

A

Requalification

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

A _____________________ consist of a select few subject matter experts respective of their discipline to evaluate and approve validation documentation.

A

validation review board

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

List the 4 Q’s from the diagram and from that list choose just ONE of the layers to describe in your own words. Do not describe more than that or points will be taken off. Be secure in your answer.

A

The four layers of the diagram are analytical instrument qualification, analytical method validation, system suitability tests, and quality control check samples. Analytical instrument qualification involves DQ, IQ, OQ, and PQ. It helps ensure that the instruments used are suited for their intended use. (diagram in lecture 9)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly