Test 1

Question 1

When did cGMP become prevelent

Answer 1

K-Harris Amendments 1962

Question 2

What is ISO internal market certification

Answer 2

Increased market share
Higher quality
Reduced customer quality audits
Greater competition

Question 3

Evidence based decision making is what

Answer 3

Sound Quality management principle

Question 4

Technical requirements for the registration of pharmaceutical for human use is what

Answer 4

Main objective of ICH

Question 5

ISO provides what

Answer 5

Standardization

Question 6

ICH guidelines that cover cGMP followed in the manufacture of AIP are found where

Answer 6

ICHQ7A

Question 7

What is the primary focus of QMP

Answer 7

To meet or exceed customer expectations

Question 8

What is design validation?

Answer 8

involves ensuring the design conforms to it’s intended use by testing performance

Question 9

The FDA’s CDRH compliance inspection which one is the most important

Answer 9

management

Question 10

Component of design control that involves – Large scale to small scale translations

Answer 10

Design Transfer

Question 11

CFR 211 PART 820

Answer 11

cGMP pharmaceuticals, quality system regulation for devices

Question 12

device history and the master record have what in common?

Answer 12

Procedures and specifications

Question 13

the consideration of human factor in device design

Answer 13

Design Input

Question 14

Center for Device and Radiological Health

Answer 14

CDRH

Question 15

Design and Dev. Planning

Answer 15

involves assigning personnel and responsibilities ans setting timeline

Question 16

What is pre-market authorization

Answer 16

is required if a new device is not substantially equivalent to other devices and has not passed the 510K process

Question 17

Most critical parameters for assisting purity

Answer 17

Cleaning procedures

Question 18

Clinical Trial phase that testing out if the drug product will work for it’s intended use in humans?

Answer 18

Phase 2

Question 19

What is the identity attribute of a drug

Answer 19

chemical or biological fingerprint of an active pharm. drug

Question 20

3 is the minimum number of batches to prove product and process consistency for what?

Answer 20

when submitting NDA to the FDA

Question 21

QC more than QA

Answer 21

conducts environmental monitoring

Question 22

Consistency means?

Answer 22

quality should be maintained with each of the batch or lot manufactured

Question 23

What is the stability of a drug

Answer 23

the quality of a drug does not change from the time the drug is manufactured to the time it expires

Question 24

consistency of the ongoing process

Answer 24

Documentation
continuous improvement
testing
validation

Question 25

ICH9 has what?

Answer 25

contains guidelines fro quality risk management

Question 26

Quality by design is in what portion of the ICH

Answer 26

ICH 8

Question 27

reaching a max # of ____causes the FDA to shut down the drug manufacturing company

Answer 27

27

Question 28

What is process risk

Answer 28

concerns issues that can cause the product of failed specification during manufacturing

Question 29

What is Product risk?

Answer 29

issues that can affect the success of the drug in the market place

Question 30

Smoke studies

Answer 30

Hospira

Question 31

bio burden

Answer 31

Alexicon

Question 32

What is the 80/20 rule

Answer 32

avoid 80% of the fails by addressing 20% of the causes

Question 33

What is Risk Mitigation

Answer 33

reduce or minimize the risk

Question 34

What is detection

Answer 34

(check quiz 4 Q8)

Question 35

Severity does what?

Answer 35

Measures the hazards to patients health

Question 36

FMEA

Answer 36

Failure modes and Effect Analysis

Question 37

A process that involves stating the product requirements and the assessing ways by which the product may fail

Answer 37

FMEA