Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Pharmaceutical Analysis II (Lec) > Concepts in Pharmaceutical Quality Assurance > Flashcards

Concepts in Pharmaceutical Quality Assurance Flashcards

1
Q

Refers to the action of proving that any procedure, process, equipment, material, activity, or system actually and consistently leads to the expected results

A

Validation

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

This team’s responsibility is to identify needs, develop protocols, and conduct validation/qualification

A

Validation team

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

Is a high-level document that establishes an umbrella validation plan for the entire product

A

Validation master plan (VMP)

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

Refers to the process of establishing documented evidence that a process used in manufacture does what it purports to do

A

Prospective validation

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

Refers to validation carried during routine production of products intended for sale

A

Concurrent validation

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

Refers to validation of a process for a product that has been marketed based upon accumulated manufacturing

A

Retrospective validation

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

Refers to repeated validation of an approved process to ensure continued compliance with established requirements

A

Revalidation

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

Refers to the action of proving and documenting that premises, systems, and equipment are properly installed

A

Qualification

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

Validation that demonstrates that an analytical procedure is suitable for its intended purpose

A

Analytical method validation

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

The ability to assess unequivocally the analyte in the presence of components which may be expected to be present

A

Specificity

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

The ability to obtain test results which are directly proportional to the concentration of analyte in the sample

A

Linearity

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

The interval between the upper and lower concentration of analyte in the sample

A

Range

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Expresses the closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value

A

Accuracy/Trueness

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Expresses the closeness of agreement between a series of measurements obtained from multiple sampling of the same homogenous sample

A

Precision

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Expresses the precision under the same operating conditions over a short interval of time

A

Repeatability/Intra-assay precision

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Expresses within-laboratories variations: different days, different analysts, different equipment, etc.

A

Intermediate precision

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

Expresses the precision between laboratories (collaborative studies, usually applied to standardization of methodology)

A

Reproducibility

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

A limit that refers to the lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value

A

Detection limit

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

A measure of the capacity to remain unaffected by small, but deliberate variations in method parameters

A

Robustness

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

Type of testing based on the concept that the equipment, electronics, analytical operations and samples to be analyzed constitute an integral system that can be evaluated as such

A

System suitability testing

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

Refers to the actions taken to remove a product from the market

A

Product recall

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

An NSAID and a prescription painkiller that was recalled in 2004 due to risk of deadly heart attacks

A

Rofecoxib (Vioxx)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

An alert issued within 24 hours after the FDA director general approves a product recall order

A

Public health alert

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

Situation in which there is a reasonable probability that the use
or exposure to the product will cause serious adverse health
consequences or death (Recall classification)

A

Class 1

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

Situation in which use or exposure to the product may cause
temporary or medically reversible adverse health consequences (Recall classification)

A

Class 2

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

Situation in which use or exposure to the product is not likely to
cause adverse health consequences (Recall classification)

A

Class 3

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

Refers to the ability to discover or determine the existence, presence, or fact of a hazard

A

Detectability

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

Refers to damage to health, including the damage that can occur from loss of product quality or availability

A

Harm

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
29
Q

Refers to the potential source of harm

A

Hazard

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
30
Q

Refers to all phases in the life of the product from the initial development through marketing until the product’s discontinuation

A

Product lifecycle

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
31
Q

Refers to the degree to which a set of inherent properties of a product, system, or process fulfills requirements

A

Quality

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
32
Q

Refers to the combination of the probability of occurrence of harm and the severity of that harm

A

Risk

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
33
Q

A systematic process for the assessment, control, communication, and review of risks to the quality of the drug product across the product lifecycle

A

Quality risk management

34
Q

The sum of all aspects of a system
that implements quality policy and ensures that quality objectives are met

A

Quality system

35
Q

Assessment that consists of the process of the identification of hazards and the analysis and evaluation of risks associated
with exposure to those hazards

A

Risk assessment

36
Q

Refers to the systematic use of information to identify hazards referring to the risk question or problem description

A

Risk identification

37
Q

Refers to the estimation of the risk associated with the identified hazard

A

Risk analysis

38
Q

An evaluation that compares the identified and analyzed risk against given risk criteria

A

Risk evaluation

39
Q

Refers to the decision making to reduce and/or to accept risks

A

Risk control

40
Q

Reduction that focuses on the process for mitigation or avoidance of quality risk when it exceeds a specified level

A

Risk reduction

41
Q

Refers to a decision to accept risk; can be a formal or passive decision

A

Risk acceptance

42
Q

Refers to the sharing of information about risk and risk management between the decision makers and other parties

A

Risk communication

43
Q

Refers to reviewing outputs/results of the risk management process

A

Risk review

44
Q

Meaning of FMEA

A

Failure mode effects analysis

45
Q

Meaning of FMECA

A

Failure mode, effects, and criticality analysis

46
Q

Meaning of FTA

A

Fault tree analysis

47
Q

Meaning of HACCP

A

Hazard analysis and critical control points

48
Q

Meaning of HAZOP

A

Hazard operability analysis

49
Q

Meaning of PHA

A

Preliminary hazard analysis

50
Q

Refers to a systematic analysis of potential failure modes aimed at preventing failures

A

Failure mode and effect analysis

51
Q

A number that is simply calculated by multiplying the severity rating, times the occurrence probability rating, times the detection probability rating of all the items

A

Risk priority number (RPN)

52
Q

Refers to the ability of a drug to retain its chemical, physical, microbiological, and biopharmaceutical properties within specified limits throughout its shelf-life

A

Stability

53
Q

The period of time during which a drug product is expected, if stored correctly, to remain within
specification as determined by stability studies on a number of batches of the product

A

Shelf life/Expiration dating period/Validity period

54
Q

Refers to a series of tests designed to obtain information on the stability of a pharmaceutical product

A

Stability tests

55
Q

Refers to the date indicating the completion date of the manufacture of a batch

A

Date of manufacture

56
Q

Refers to the date placed on the container of a drug product that designates the date up to and
including which the product is expected to remain within specification if stored correctly

A

Expiration date

57
Q

Refers to the period of time for which the API remains within specification when stored under the recommended conditions in the proposed bulk storage container

A

Re-test period

58
Q

Refers to the shelf-life determined by projecting results from accelerated stability studies

A

Provisional shelf-life

59
Q

Refers to the period of time during which a reconstituted preparation or the finished dosage form in an opened multidose container can be used

A

Utilization period

60
Q

Type of testing that establishes the “period of time during which a multidose product can be used while retaining quality within an accepted specification once the container is opened”

A

In-use stability testing

61
Q

Refers to conditions that involve storage in dry, well-ventilated premises at temperatures of 15-25°C, or depending on climatic conditions, up to 30°C

A

Normal storage conditions

62
Q

Type of testing designed to increase the rate of chemical degradation and physical change of a drug by using exaggerated storage conditions

A

Accelerated stability testing

63
Q

Studies on the physical, chemical, biological, biopharmaceutical, and microbiological characteristics of a drug, during and beyond the expected shelf-life

A

Real-time stability studies

64
Q

Refers to a list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical in limits, ranges, or other criteria for the tests described

A

Specifications

65
Q

Refers to the specifications that determine the suitability of a drug substance throughout its retest period

A

Shelf-life specifications

66
Q

Refers to the specifications that determine the suitability of a drug product at the time of its release

A

Release specifications

67
Q

Stability tests are performed to provide a means of comparing alternative formulations (Phases of development)

A

Product development phase

68
Q

The drug regulatory authority will require the manufacturer to submit information on the stability of the product (Phases of development)

A

Registration phase

69
Q

The manufacturer carries out on-going real-time stability studies to substantiate the expiry date and the storage conditions previously projected (Phases of development)

A

Post-registration phase

70
Q

Each active ingredient retains its chemical integrity and labeled potency within the specified limits (Type of stability)

A

Chemical stability

71
Q

The original physical properties, including appearance, palatability, uniformity, dissolution, and suspendability, are retained (Type of stability)

A

Physical stability

72
Q

Sterility or resistance to microbial growth is retained according to the specified requirements (Type of stability)

A

Microbiological stability

73
Q

The therapeutic effect remains unchanged (Type of stability)

A

Therapeutic stability

74
Q

No significant increase in toxicity occurs (Type of stability)

A

Toxicological stability

75
Q

Temperate (International climactic zone)

A

Zone I

76
Q

Subtropical, with possible high humidity (International climactic zone)

A

Zone II

77
Q

Hot/dry (International climactic zone)

A

Zone III

78
Q

Hot/humid (International climactic zone)

A

Zone IV

79
Q

ASEAN nations & Brazil have adopted __________°C & __________% RH

A

30°C & 75% RH

80
Q

A design in which only the extremes are tested at all time points (Types of reduced study designs)

A

Bracketing

81
Q

A design in which a selected subset of samples is tested (Types of reduced study designs)

A

Matrixing

Pharmaceutical Analysis II (Lec) (8 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2025 Bold Learning Solutions. Terms and Conditions