Q8 W9

Question 1

Computer Validation is similiar to:

Installation Qualification
Method Validation
Operational Qualification
Process Validation
Performance Qualification

Answer 1

Installation Qualification

Question 2

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

Answer 2

DQ, IQ, OQ, PQ, RQ

Question 3

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

Answer 3

Design Qualification

Question 4

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

Answer 4

Lack of validation of sterilization protocol

Question 5

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

True
False

Answer 5

False

Question 6

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

Answer 6

Vendor Information Sheet

Question 7

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

Computer Validation
Method Validation
Design Qualification
Performance Qualification
Operational Qualification

Answer 7

Method Validation

Question 8

________________ 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

Answer 8

Requalification

Question 9

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

Answer 9

validation review board

Question 10

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.

Answer 10

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)