QA

Question 1

Total features or conformance to SPECIFICATIONs of a product

Answer 1

Quality

Question 2

A list of detailed requirements with which a product has to conform (tests, references of procedures, and
acceptance criteria)

Answer 2

Specifications

Question 3

Quality is everybody’s business

Answer 3

Total Quality Management (TQM)

Question 4

Sum total of the organized activities made with the objective of ensuring that products are of quality required for
intended use

Answer 4

Quality Assurance

Question 5

Part of QA which ensures that products are consistently produced & controlled to quality standards appropriate to intended use

Answer 5

Current Good Manufacturing Practice (cGMP)

Question 6

PIC/S

Answer 6

Pharmaceutical Inspection Cooperation Scheme

Question 7

old cGMP

Answer 7

AO 220 S. 1974

Question 8

Part of cGMP concerned with sampling. specification, testing, organization, documentation, and release procedures

Answer 8

Quality Control

Question 9

“If it’s not written, It never happpened.”

Answer 9

Documentation

Question 10

It is the linkage between written records of action taken and the quality operation

Answer 10

Documentation

Question 11

Regular periodic quality review of all registered drug products to verify consistency of existing processes and to identify improvement

Answer 11

Product Quality Review

Question 12

Systematic process for the assessment, control, communication, and review of risks to the quality of the product

Answer 12

Quality Risk Management

Question 13

Combination of probability of the occurrence of harm and the severity of harm

Answer 13

Risk

Question 14

Aim to improve its performance by learning about good practices through working at those process in other, better-performing organizations, building on evaluation of relevant performances in own and other organizations

Answer 14

Benchmarking

Question 15

Portion of a batch

Answer 15

Lot

Question 16

An organizational unit independent of Production which fulfills both QA and QC responsibilities

Answer 16

Quality Unit

Question 17

A set of activities that ensures quality in the process by which the products are developed.

Answer 17

Quality Assurance

Question 18

Specific amount produced in a unit time or according to a single manufacturing order during the same cycle of manufacture, sharing the same production conditions and date

Answer 18

Batch

Question 19

A set of activities that ensures quality in the product

Answer 19

Quality Control

Question 20

Aims to prevent defects in the process used to make the products.

Answer 20

Quality Assurance

Question 21

Aims to identify and control defects in the finished product.

Answer 21

Quality Control

Question 22

Audit and Monitoring

Answer 22

Quality Assurance

Question 23

Primary contact with regulatory agency

Answer 23

Quality Assurance

Question 24

Prepares SOPs

Answer 24

Quality Assurance

Question 25

Conducts sampling and testing of RM and FP

Answer 25

Quality Control

Question 26

Inspects PM components

Answer 26

Quality Control

Question 27

Performs environmental monitoring

Answer 27

Quality Control

Question 28

Process-Oriented

Answer 28

Quality Assurance

Question 29

Product-Oriented

Answer 29

Quality Ciontrol

Question 30

Testing the quality of bulk ingredients and container

Answer 30

Raw Material QC

Question 31

Testing the quality of intermediate products (e.g. granules prior tablet compression)

Answer 31

In-process Material QC

Question 32

Testing the final dosage form in its container

Answer 32

Finished Product QC

Question 33

Written standard published in compendium (USP/BP/Eur/PP) that describes an article

Answer 33

Monograph

Question 34

Step-by-step instruction for doing a particular task or activity

Answer 34

Standard Operating Procedure (SOP)

Question 35

Show the actual results of all tests conducted to show compliance with standards

Answer 35

Certificate of Analysis

Question 36

Describe the tests conducted on a particular material, along with the acceptable criteria, results, and disposition.

Answer 36

Certificate of Analysis

Question 37

Quality attributes approved by a regulatory body

Answer 37

Monograph

Question 38

Information on potential health effects of exposure and safe working procedures when handling

Answer 38

Material Safety Data Sheet (MSDS)

Question 39

Properties of a particular hazardous substance or chemical

Answer 39

Material Safety Data Sheet (MSDS)

Question 40

Process of removal of an appropriate number of items (n) from a population (N) in order to make an inference to the entire population

Answer 40

Sampling

Question 40

Most common military standard sampling plans (old)

Answer 40

MIL-STD-105E

Question 41

is a widely used standard for inspection by variables

Answer 41

MIL-STD-144

Question 42

Common acceptance sampling system used for inspection by attributes (New)

Answer 42

ANSI/ASQ ZI.4-2008

Question 43

Used for measurable characteristics

Answer 43

X-BAR chart

Question 44

Alerts the operator to closely monitor the process

Answer 44

Warning Limit

Question 45

Stop the process and do corrective actions

Answer 45

Actions or Control

Question 46

Non-Proportion, Number of defects

Answer 46

np-Chart

Question 47

Most used chart. Proportion or percent of defects; versatile

Answer 47

p-Chart

Question 48

Proving and documenting that any process, procedure, or method actually leads to the expected results.

Answer 48

Validation

Question 49

Proving that premises, systems, or equipment work correctly and actually lead to expected results.

Answer 49

Qualification

Question 50

Type of Data that is Continuous

Answer 50

Variable

Question 51

Type of Data that is Whole

Answer 51

Attribute

Question 52

The quality between supplier 1 and 2 are not the same

Answer 52

Material

Question 53

Some parts of the equipment are not well-maintained

Answer 53

Machine

Question 54

The working instruction is written in jargon

Answer 54

Method

Question 55

Overfatigue, lacking PPE

Answer 55

Man

Question 56

Non-conformance to a standard or requirement

Answer 56

Product Defects

Question 57

Graphs on which the quality of product is plotted as manufacturing is actually proceeding

Answer 57

Control Charts

Question 58

May endanger the life of patient and render the product non-functional

Answer 58

Critical Defect

Question 59

May affect the function of product and render it useless

Answer 59

Major Defect

Question 60

Defects in Neither, discoloration, labels

Answer 60

Minor Defect

Question 61

A defect measured by instrument

Answer 61

Variable Defect

Question 62

A defect by inspection (sense)

Answer 62

Attribute Defect

Question 63

A defect that is seen by the naked eye

Answer 63

Ocular Defect

Question 64

A defect that CANNOT be seen by the naked eye

Answer 64

Internal Defect

Question 65

Defect in which function is incorrect (MDI, dissol.)

Answer 65

Performance Defect

Question 66

Type of defect: The actuator of the MDI is stuck

Answer 66

Major Defect

Question 67

The type of defect: Metal Particles inside a parenteral vial

Answer 67

Clinical Defect

Question 68

Type of Defect: The sticker label was lighter in color when printed out

Answer 68

Minor Defect

Question 69

Type of Defect: Scratches on the amber bottle surface of an oral syrup

Answer 69

Minor Defect

Question 70

What class in product recall that is: Death or serious ADR

Answer 70

Class I

Question 70

A removal form market; either defective or potentially harmful

Answer 70

Product Recall

Question 71

What class in product recall that is: Temporary or medically reversible ADR

Answer 71

Class II

Question 72

What class in product recall that is: Not likely to cause any serious ADR

Answer 72

Class III

Question 73

It is the capacity of a drug to remain within specification

Answer 73

Stability

Question 74

What is the minimum acceptable potency of stability

Answer 74

90%

Question 75

Prevented by reduction/elimination of water from preparation

Answer 75

Hydrolysis

Question 76

Prevented by antioxidants

Answer 76

Oxidation

Question 77

Prevented by using light-resistant container

Answer 77

Photolysis

Question 78

Period of time during a product remains within specification

Answer 78

Shelf-Life

Question 79

Shelf-life is estimated using what equation?

Answer 79

Arrhenius equation

Question 80

Time or date prior to which product is expected to remain stable and after which it must not be used

Answer 80

Expiration Date

Question 81

Risk of rejecting a true null hypothesis

Answer 81

Alpha risk, type I error

Question 82

An inspection/test may indicate that a product or process is defective when it is actually acceptable.

Answer 82

Alpha risk, type I error

Question 83

Harms the company

Answer 83

Alpha risk, type I error

Question 84

Accepting a false null hypothesis

Answer 84

Beta risk, type II error

Question 85

An inspection/test may indicate that a product or process is acceptable when it is actually defective

Answer 85

Beta risk, type II error

Question 86

i can be reduced by increasing sample size or improving the accuracy of the measurement tool.

Answer 86

Beta risk, type II error

Question 87

Zone I

Answer 87

Temperate

Question 88

Zone II

Answer 88

Subtropical/Mediterranean

Question 89

Zone III

Answer 89

Hot and Dry

Question 90

Zone IVa

Answer 90

Hot and Humid

Question 91

Zone IVb

Answer 91

Hot and very humid

Question 92

Temperature of Zone I

Answer 92

21 ± 2°C

Question 93

Temperature of Zone II

Answer 93

25 ± 2°C

Question 94

Temperature of Zone III, IVa, and IVb

Answer 94

30 ± 2°C

Question 95

Relative Humidity: Zone I

Answer 95

45 ± 5%

Question 96

Relative Humidity: Zone II

Answer 96

60 ± 5%

Question 97

Relative Humidity: Zone III

Answer 97

35 ± 5%

Question 98

Relative Humidity: Zone IVa

Answer 98

65 ± 5%

Question 99

Relative Humidity: Zone IVb

Answer 99

75 ± 5%

Question 100

Elucidates intrinsic stability of drug & identify the likely degradation products

Answer 100

Stress Testing

Question 101

Conducted under normal conditions

Answer 101

Long-term/Real Time Studies

Question 102

Follows Zero-order kinetics

Answer 102

Long-term/Real Time Studies

Question 103

Designed to increase rate of chemical degradation by using Exaggerated storage conditions

Answer 103

Short-Term/Accelerated Studies

Question 104

Follows First order kinetics

Answer 104

Short-Term/Accelerated Studies