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PHAN 211 - Pharmaceutical Analysis > Wk 1 - Introduction to Quality Control > Flashcards

Wk 1 - Introduction to Quality Control Flashcards

1
Q

the combination of attributes or characteristics of a product which, when compared to a standard, serves as a basis for measuring the uniformity of the product and determines its degree of acceptability

A

Quality

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2
Q
A

Control

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3
Q
A

Quality Control

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4
Q
A

Quality Assurance

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5
Q

QA vs QC

Quality Assurance

A
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6
Q

QA vs QC

Quality Control

A
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7
Q
A

Quality Control System

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8
Q

What are the benefits of establishing a Quality Control System?

A
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9
Q
A

Benchmarking

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10
Q

TQM

A

Total Quality Management

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11
Q

What are the primary elements of TQM?

A
  • Customer focused
  • Total employee involvement
  • Process-centered
  • Integrated system
  • Strategic and Systematic
  • Continual improvement
  • Fact-based decision making
  • Communications
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12
Q

quality assessment with an attached judgment that the evaluated unit is good enough to have the right to exist in a particular system.

A

Accreditaton

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13
Q

Accreditation is usually given for a limited amount of time and is renewed and repeated in a cyclical process. For how many years is accreditation valid?

A

4 to 10 years

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14
Q

A voluntary, non-treaty federation of standards setting bodies of some 130 countries, promoting the development of standardization and related activities to facilitate international trade in goods and services, and cooperation on economic, intellectual, scientific, and technological aspects

ISO

A

The International Organization for Standardization (ISO)

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15
Q

When and where was ISO first founded?

A

Geneva (1946-1947) as a UN agency

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16
Q

a public statement by a certified auditor that an organization lives up to the ISO standards.

A

ISO certification

17
Q

What aspects of organization of quality control should be defined by a manufacturing firms?

A
  • functions and responsibilities
  • effective coordination
  • all activities perforomed towards the production of the product (highest std, lowest cost)
18
Q

Common divisions of a Manufacturing firm

A
  1. Finance
  2. Production
  3. Quality Assurance and Control
  4. Marketing (but may be optional in 3rd party contract)
19
Q

Manufacturing process must be done in compliance with?

cGMP

A

Current Good Manufacturing Practice

(Administrative Order No. 220, s. 1974)

20
Q
A

Quality control department

21
Q

What are the control functions?

A
  • Analysis Function
  • Monitor Function
  • Record Review and Release Function
  • Audit Function

PHAN 211 - Pharmaceutical Analysis (2 decks)

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