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PHA6122 LEC Pharmaceutical Analysis 2 > Quality Management in the Drug Industry > Flashcards

Quality Management in the Drug Industry Flashcards

1
Q

aspect of management function that determines and implements “quality policy”

A

quality management

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2
Q

quality policy is formally expressed and authorized by _______________________________

A

top management

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3
Q

overall intention and direction of an organization regarding quality

A

quality policy

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4
Q

2 basic elements of quality mangement

A
  1. quality system
  2. quality assurance
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5
Q

organizational structure, procedures, processes, and resources

A

quality system

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6
Q

systematic action necessary to ensure adequate confidence that a product or service will satisfy given requirements for quality

A

quality assurance

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7
Q

part of quality system

A

quality assurance

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8
Q

quality assurance is an overall organizational body to assure ______________________

A

product quality

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9
Q

T/F: quality system pertains to the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended uses

A

F: quality assurance

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10
Q

____________________ must assume responsibility for the quality of the pharmaceutical products

A

manufacturer

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11
Q

the attainment of quality assurance is the responsibility of ___________________ and requires the participation and commitment of ____________

A

senior management; staff

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12
Q

to achieve quality objective reliably, there must be a _____________________ and _______________________ of quality assurance

A

comprehensively designed and correctly implemented system

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13
Q

part of quality assurance

A

GMP

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14
Q

ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use

A

GMP

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15
Q

GMP are aimed primarily at _____________________ inherent in any pharmaceutical production

A

diminishing the risks

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16
Q

two types of risks involved in GMP

A
  1. cross-contamination
  2. mix-ups (confusion)
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17
Q

unexpected contaminants

A

cross-contamination

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18
Q

false labels being put on containers

A

mix-ups

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19
Q

part of GMP

A

QC

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20
Q

QC is the ________________________ to ensure identity and purity of a particular pharmaceutical

A

sum of all procedures

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21
Q

a combination of attributes and characteristics then compared to a standard

A

quality

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22
Q

quality is used as a basis of _______________

A

uniformity

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23
Q

quality determines the degree of ____________________

A

acceptability

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24
Q

5 criteria for measuring quality

A
  1. conformance
  2. fitness for use
  3. reliability
  4. yield
  5. customer satisfaction
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25
Q

types of quality costs

A
  1. failure costs (cost of non-quality)
  2. appraisal costs
  3. prevention costs
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26
Q

failure cost is also referred as __________________________

A

cost of non-quality

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27
Q

what criteria is used:
ensures that product is within prescribed limits

A

conformance

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28
Q

what criteria is used:
ensures functionality of product

A

fitness for use

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29
Q

what criteria is used:
ensures function in specified environment for a prescribed time

A

reliability

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30
Q

what criteria is used:
ensures a high degree of acceptable units

A

yield

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31
Q

what criteria is used:
ensures safe, pure, effective product based on survey, safety, and toxicity monitoring

A

customer satisfaction

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32
Q

T/F: A satisfied customer indicates quality product

A

T

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33
Q

reporting responsibilities: higher management is composed of

A
  1. scientific vp
  2. manufacturing vp
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34
Q

reporting responsibilities: scientific vp is composed of

A
  1. R&D
  2. QC
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35
Q

reporting responsibilities: manufacturing vp is composed of

A
  1. purchasing
  2. production
  3. warehouse
  4. maintaining
36
Q

what is the overarching philosophy articulated in both the current GMP regulations and in robust modern quality systems?

A

quality should be built into the product, testing alone cannot be relied on to ensure product quality

37
Q

building quality into the product is the responsibility of _____________________ and ____________

A

quality assurance and GMP

38
Q

T/F: Building quality into the product is handled by Quality Assurance and GMP, but not Quality Control.

A

T

39
Q

7 benefits from a quality control system

A
  1. minimizes or eliminates risk of marketing unsafe products
  2. guarantees conformance to regulatory requirements
  3. guarantees product efficacy
  4. reduces operating costs
  5. reduces operating losses
  6. produces higher employee morale
  7. motivates the pharmaceutical/medical professions to sell or prescribe the product
40
Q

tool that has been used in many industries, usually within a total quality management or performance improvement programme

A

cost of quality

41
Q

failure costs can be categorized as _____________ and _______________

A
  1. tangible costs
  2. intangible costs
42
Q

cost associated with getting things wrong

A

failure cost

43
Q

cost of rejects or reworks (e.g., did not follow the manufacturing batch records)

A

tangible cost

44
Q

lost sales, damage to image, or problems with regulatory authorities

A

intangible costs

45
Q

costs associated with checking that things were done correctly

A

appraisal costs

46
Q

cost you spend in quality control for testing your product

A

appraisal costs

47
Q

costs associated with making sure that things will be done right

A

prevention costs

48
Q

cost that you can spend on

A

prevention costs

49
Q

considered a value adding cost

A

preventive costs

50
Q

part of a standard

A

specifications

51
Q

specifications is defined as (3)

A
  1. lists of tests
  2. references to analytical procedures
  3. appropriate acceptance criteria
52
Q

contains the specifications (i.e., list of tests, references of analytical procedures, and acceptance criteria specific to the test)

A

specification sheet

53
Q

type of standards

A
  1. pharmacopeial standards
  2. in-house standards
  3. regulatory standards
54
Q

found in published monographs

A

pharmacopeial standards

55
Q

unofficial standards; official only to the manufacturer

A

in-house standards

56
Q

mandated by regulatory agencies (e.g., FDA, WHO, US FDA)

A

regulatory standards

57
Q

addresses various aspects of quality management and contains some of ISO’s best known standards

A

ISO 9000 family

58
Q

ISO 9000 family includes

A
  1. ISO 9001:2008
  2. ISO 9000:2005
  3. ISO 9004:2009
  4. ISO 9011:2011
59
Q

sets out the requirements of a quality management system (QMS)

A

ISO 9001:2008

60
Q

covers the basic concepts and language

A

ISO 9000:2005

61
Q

focuses on how to make a QMS more efficient and effective

A

ISO 9004:2009

62
Q

sets out guidance on internal and external audits of quality management systems

A

ISO 9011:2011

63
Q

correct the occurrence

A

corrective action

64
Q

prevent the recurrence

A

preventive action

65
Q

allowable variation or deviation of products

A

quality variation

66
Q

subject to variation

A

quality characteristics

67
Q

undesirable characteristic of a product

A

defect

68
Q

failure to conform to specifications

A

defect

69
Q

unit of a product, which contains one or more defects

A

defective

70
Q

how are defects classified

A
  1. according to measurability
  2. according to seriousness or gravity
  3. according to nature
71
Q

enumerate the defects according to measurability

A
  1. variable defect - measured directly by instruments
  2. attribute defect - not measured directly by instruments
72
Q

enumerate defects according to seriousness/gravity

A
  1. critical defect - endanger life or property
  2. major defect - affect function and may render it useless
  3. minor defect - does not endanger life nor affect function
73
Q

enumerate defects according to nature

A
  1. ocular defect - visible
  2. internal defect - cannot be seen but present and detectable
  3. performance defect - function defect
74
Q

may be due to chance or assignable causes

A

errors

75
Q

T/F: Increase use of materials, decrease risk of errors

A

F (increase risk of errors)

76
Q

sources of variation (4Ms)

A
  1. materials
  2. machines
  3. methods
  4. men
77
Q

alert individuals who have experience and who are familiar with the physical characteristics of the materials they sample and are well versed in sampling techniques

A

inspectors

78
Q

area of operation that inspect the deliveries and inventory

A

warehouse

79
Q

area of operation that check the quality of the manufactured products; in-process testing

A

manufacturing

80
Q

area of operation where packaged products are checked

A

packaging areas

81
Q

enumerate microbiological tests

A
  1. antimicrobial effectiveness testing
  2. microbial enumeration/limit test
  3. sterility tests
82
Q

test organisms involved in antimicrobial effectiveness testing

A
  1. C. albicans
  2. A. niger
  3. E. coli
  4. P. aeruginosa
  5. S. aureus
83
Q

culture media that can be used for microbial enumeration/limit test

A
  1. pH 7.2 phosphate buffer
  2. fluid soybean-casein digest
  3. fluid lactose medium
84
Q

test organisms involved in microbial enumeration/limit test

A
  1. A. brasiliensis
  2. Bacillus subtilis
  3. C. albicans
  4. S. aureus
  5. E. coli
  6. Salmonella typhimurium
85
Q

2 techniques involved in sterility tests

A
  1. membrane filtration
  2. direct inoculation into the medium

PHA6122 LEC Pharmaceutical Analysis 2 (2 decks)

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