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Quality Control > M1 INTRODUCTION TO QUALITY CONTROL AND QUALITY ASSURANCE OF PHARMACEUTICAL PRODUCTS > Flashcards

M1 INTRODUCTION TO QUALITY CONTROL AND QUALITY ASSURANCE OF PHARMACEUTICAL PRODUCTS Flashcards

1
Q

Dimensions of Quality (Garvin, 1987)

A

A. Aesthetics
B. Features
C. Perceived Quality
D. Conformance to Standards
E. Performance
F. Reliability
G. Durability
H. Serviceability

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2
Q

“How often does the product fail?”

A

Reliability

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3
Q

“Our internet connection never disappoints us.”

A

Reliability

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4
Q

“Will the product do the intended job?”

A

Performance

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5
Q

“The ballpen I bought writes smoothly”.

A

Performance

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6
Q

“How long does the product last?

A

Durability

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7
Q

“Our electric fan is still working since 1989.”

A

Durability

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8
Q

“How easy is it to repair the product?”

A

Serviceability

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9
Q

“I accidentally downloaded a malware in my phone. Good thing the Service Center was able to remove it.”

A

Serviceability

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10
Q

“What does the product look like?”

A

Aesthetics

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11
Q

“The shoes I purchased online looks authentic.”

A

Aesthetics

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12
Q

“Samsung S9 offers iris/fingerprint scanner and fast battery charging.”

A

Features

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13
Q

“What does the product do?”

A

Features

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14
Q

“What is the reputation of the company or its product?

A

Perceived Quality

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15
Q

“Where do you usually buy your medicines?”

A

Perceived Quality

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16
Q

“Is the product made exactly as the designer intended?”

A

Conformance to Standards

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17
Q

“The tailored uniform fits perfectly. ”

A

Conformance to Standards

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18
Q

Quality is fitness for use

A

– Juran, 1988
– It places emphasis on the consumer aspect of
quality.
– It emphasizes that requirements and
specifications translate fitness for use into
measurable quantities.
– Example: Glucometer

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19
Q

Quality is conformance to requirements or specifications.

A

– Gilmore, 1974
– In order to manage quality adequately, we must be able to quantify and measure it.
– Example: Labeled claim of medicines

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20
Q

consumer aspect of
quality

A

Quality is fitness for use.

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21
Q

Quality is fitness for use with customer satisfaction

A

– ISO 9000, 2000
– ISO- International Organization for standardization
* ISO is NOT an acronym.
* Greek word “isos” – “equal”
– Customer satisfaction is the main determinant of quality.
– Example: Quality education

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22
Q

ISO

A

International Organization for standardization

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23
Q

“isos”

A

“equal

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24
Q

Customer satisfaction is the main determinant of quality.

A

Quality is fitness for use with
customer satisfaction

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25
Q

Quality is inversely proportional to variability.

A

– Montgomery, 2013
– If the variability in a product’s important
characteristics decreases, the quality of the
product increases.
– Thus, quality improvement is the
reduction of variability in processes and
products.

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26
Q

If the variability in a product’s important characteristics decreases

A

the quality of the
product increases

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26
Q

is the reduction of variability in processes and products.

A

quality improvement

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27
Q

–Every product possesses a number of elements that jointly describe what the user or consumer thinks of as quality.

A

Quality Characteristics

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27
Q

no two products are ever identical (True or False)

A

True

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27
Q

– characteristics that have discrete values and can be
counted (Accept/Reject, Pass/Fail, Go/No-Go)

A

ATTRIBUTES

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28
Q

In order to manage quality adequately, we must be able to?

A

quantify and measure it.

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28
Q

– length, weight, diameter, time

A

VARIABLES

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29
Q

– “Measure”

A

VARIABLES

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29
Q

– “Classify

A

ATTRIBUTES

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29
Q

– characteristics that can be measured

A

VARIABLES

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29
Q

– % defective, number of flaws in a shirt, number of broken eggs in a box, etc.

A

ATTRIBUTES

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30
Q

are often evaluated relative to specifications

A

Quality Characteristics

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31
Q
  • the desired value for that quality characteristic
A

Nominal or target value

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31
Q

largest allowable
value

A

Upper specification limit (USL)

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32
Q

smallest allowable
value

A

Lower specification limit (LSL)

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32
Q

fail to meet one or more of its specifications

A

Nonconforming products

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33
Q

can be counted/classified

A

ATTRIBUTE

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34
Q

(a) Either a student PASS or FAIL

A

ATTRIBUTE

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35
Q

(b) Grades:
> 70%  PASS
< 70%  FAIL

A

VARIABLE

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36
Q

Accept/Reject

A

ATTRIBUTE

36
Q

can be measured

A

VARIABLE

36
Q

Length, width

A

VARIABLE

36
Q

The tablet is 24 mm thick

A

VARIABLE

37
Q

11 defective products were detected

A

ATTRIBUTE

38
Q

The weather can be sunny, cloudy, raining, or snowing.

A

ATTRIBUTE

39
Q

“regulatory process” through which we measure actual quality performance.
(Juran, 1974)

A

Quality Control

40
Q

Reliance on appropriate “analytical tests”

A

Quality Control

41
Q

Product Oriented

A

Quality Control

41
Q

Operational techniques

A

Quality Control

42
Q

l “planned and systematic activities” implemented within the quality system that can be demonstrated “to provide confidence” that a product or service will fulfill requirements for quality

A

Quality Assurance (QA)

43
Q

Process

A

Quality Assurance (QA)

44
Q

Applies at all stages of the manufacturing
process.

A

Quality Assurance (QA)

44
Q

Features of QA Systems
- inspection/checking

A

Audit Process

45
Q

Features of QA Systems
- purpose and objective

A

Quality Policy

45
Q

Features of QA Systems
- materials, equipment, personnel

A

Resources

46
Q

Features of QA Systems
– procedures and standards

A

Documentation

46
Q

Benefits of QA

A
  1. higher standards of production,
  2. compliance with regulatory requirements,
  3. reduced waste, and
  4. loss risk of product defects
47
Q

makes sure that quality control is doing what it should be doing.

A

Quality assurance

48
Q

proactive

A

Quality assurance

49
Q

audits

A

Quality assurance

50
Q

focused on process

A

Quality assurance

51
Q

prevents defects

A

Quality assurance

52
Q

focused on products

A

Quality Control

52
Q

finds defects

A

Quality Control

53
Q

testing

A

Quality Control

54
Q

reactive

A

Quality Control

55
Q

Types of Product

A
  1. Raw material
  2. In-process material
  3. Finish product
55
Q

“Development of strategic activities”
designed to improve the quality of a
product.

A

Quality Planning

55
Q

Drugs are special
(True or False)

A

True

56
Q

Manufacturing Process

A
  1. Personnel
  2. Premises & Equipment
  3. Procedure
  4. Product
57
Q

Warehouse (Stickers)

A
  1. Quarantine (Orange)
  2. Approved (Green)
  3. Rejected (Red)
58
Q

should not induce further harm

A

drugs

59
Q

Confirms the existence of active
ingredient/s

A

Identity

60
Q

Should not have significant quantities
of other products from cross-contamination

A

Purity

61
Q

Should contain the declared amount
of API

A

Strength or Potency

62
Q

Specified average content range

A

Strength or Potency

63
Q

OVERAGE - To ensure long shelf-life,
products contain with maximum
allowable amount
– Margin or safety for slight losses over time

A

Strength or Potency

64
Q

Consistency, colors, shape and sizes should not vary significantly.

A

Uniformity of Dosage Forms

65
Q

– may suggest problems with quality parameters.
–May not reflect safety or efficacy but could influence product acceptability.

A

Variation

66
Q

Speed and completeness with which a pharmaceutical administered in a specific form enters the bloodstream.

A

Bioavailability

67
Q

(rate and extent)

A

Bioavailability

68
Q

Absorption

A

Bioavailability

69
Q

– Comparative bioavailability

A

BIOEQUIVALENCE

70
Q

A pharmaceutical product must retain its properties within specified limits

A

Stability

71
Q
  • Expiration Date
  • Depends on API
    – Formulation
    – packaging
A

Stability

72
Q

– Physical and chemical deterioration
– Reduced potency
– Formation of toxic by-products

A
  • Improper storage and distribution
72
Q

LADMER

A

Liberation
Absorption
Distribution
Metabolism
Excretion
Response

73
Q

Formulation of dosage form

A

Liberation

74
Q

Absorption

A

Bioavailability

75
Q

Efficacy to go to the site of action - active

A

Distribution

75
Q

to inactivate the drug

A

Metabolism

76
Q

Removed from the body after deactivating the drug

A

Excretion

76
Q

Pharmacologic Action
- activated drug distribution

A

Response

77
Q
  • Starting materials
  • Manufacturing process
  • Equipment
  • Packaging
  • Storage
  • Transportation
A

Pharmaceutical Quality

78
Q
  • Where quality standards are “published periodically”
  • Provide detailed descriptions of pharmaceutical “characteristics and analytical techniques.”
A

Pharmacopeias

79
Q

– Major manufacturing and exporting countries in EU

A
  • European Pharmacopeia
80
Q

Includes monographs on finished dosage
forms

A
  • WHO International Pharmacopeia
80
Q

Qualitative test

A

Identification

81
Q

– Complex and expensive analytical procedures

A
  • United States Pharmacopeia
81
Q

Provides “detailed parameters” that are used to determine whether a medicine meets key quality attributes
1. the name of the ingredient or preparation;
2. the definition;
3. packaging, storage, and labeling
requirements; and
4. the specification.

A

Pharmacopeial Monograph

82
Q

Quantitative test

A

Assay

82
Q

Contaminants in trace amounts

A

Impurities

83
Q

NMT

A

Not more than

84
Q

NLT

A

Not less than

85
Q

To ensure that each medicine reaching a patient is
–SAFE
–EFFECTIVE, and of
–ACCEPTABLE QUALITY

A

Pharmaceutical QA

86
Q
  • Toxicity or ADRs
  • Prolonged illness
  • Death
  • Wastes money
  • Affect health system credibility
A

Consequences of Poor Quality Pharmaceuticals

87
Q

Most counterfeiting cases occur in
less developed and developing
countries, where poverty and loose
regulatory oversight make marketing
counterfeits easier.

A

Prevalence of Poor Quality
Pharmaceuticals

Quality Control (4 decks)

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