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Pharm Ana 1 LEC > (Prelim) Introduction to Quality Control [Pharm Ana 1 LEC] > Flashcards

(Prelim) Introduction to Quality Control [Pharm Ana 1 LEC] Flashcards

1
Q

QUALITY

A

Degree of excellence (Webster’s Dictionary)

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2
Q

QUALITY

A

Sum of all factors which contribute directly or
indirectly to the safety, effectiveness, and
reliability of the product

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3
Q

QUALITY

A

“Doing it right the first time and all the time”.
(TQM)

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4
Q

QUALITY

A

Excellence that is better than a minimum standard

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5
Q

QUALITY

A

Drug quality is our main business.

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6
Q

QUALITY

A

Reality: Poor quality drugs do not meet official
standards for:
○ Strength
○ Quality
○ Purity
○ Packaging
○ Labelling

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7
Q

Poor quality drugs do not meet official
standards for:

A

○ Strength
○ Quality
○ Purity
○ Packaging
○ Labelling

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8
Q

DRUG QUALITY IN THE WORLD…

A

Availability of substandard and counterfeit drugs in disturbing proportion in many low-income countries

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9
Q

DRUG QUALITY IN THE WORLD…

A

Lack of reliable drug quality assurance systems in many developing countries

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10
Q

IMPLICATIONS

A

● Treatment failure
● Adverse effects
● Increased morbidity
● Mortality
● Development of drug resistance
● Wasted resources

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11
Q

2 types of Quality

A
  1. Quality Assurance
  2. Quality Control
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12
Q

QUALITY CONTROL (QC)

A

The sum of all tests performed to determine the conformance of the product to specification

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13
Q

ROUTINE of Quality Control

A
  • RM and Analysis
  • Intermediate stage analysis
  • Finished Product Analysis
  • Stability Studies
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14
Q

Quality Control

A
  • Guarantees that the product:
    ○ Is free of impurities
    ○ Physically and chemically stable
    ○ Contains the amount of active
    ingredients as stated in the label
    ○ Provides optimal release of active
    ingredients when the product is
    administered
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15
Q

NON- ROUTINE of Quality Control

A
  • Calibration & Preventive maintenance of instruments
  • Preparation of reference/ working standards
  • Method development and Validation
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16
Q

Quality Assurance

A

Over-all organizational body designed to assure product quality

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17
Q

Quality Assurance

A

Sum of all processes performed to ensure that
the product possess all the characteristics it is
intended to have

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18
Q

FOCUS QA

A

To prevent defects with a focus on process

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19
Q

FOCUS QC

A

To identify defects after in the product

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20
Q

GOAL QA

A

To improve development and test processes so that defects do not arise

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21
Q

GOAL QC

A

To identify defects after a product is developed and before it is released.

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22
Q

How QA

A

Establish a good QMS and assessment of its adequacy with continuous monitoring

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23
Q

How QC

A

Finding sources of quality problems to continually meet customer’s requirements

24
Q

Responsibility QA

A

Everyone on the team

24
Q

What QC

A

Analytical techniques used to maintain the product quality and process.

24
Q

What QA

A

Prevention of quality problems through planned and systematic activities

25
Q

Responsibility QC

A

Of a specific team that tests the product for defects

25
Q

As a tool QA

A

QA is a managerial tool

26
Q

As a tool

A

QC is a corrective tool

27
Q

QUALITY MANAGEMENT SYSTEM

A

All manufacturing activities of a laboratory are
based on cGMP, AO 43, WHO guidelines, ISO,
EU

28
Q

cGMP

A

Current Good Manufacturing Practices

29
Q

cGMP

A

These regulations, which have the force of law,
require that manufacturers, processors, and
packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective

30
Q

cGMP

A

This regulations require a quality approach to
manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups,
and error

31
Q

cGMP

A

This in turn, protects the consumer from
purchasing a product which is not effective or
even dangerous

32
Q

BENEFITS

A

● Eliminates the risk of marketing unsafe product
● Guarantees conformance to regulatory
requirement
● Guarantees product efficacy
● Reduces operating cost
● Reduces operating loses
● Produces higher employee morale
● Motivates health care professional to sell or
prescribed the product

33
Q

QUALITY RESPONSIBILITY

A

Quality is the collective responsibility of every
individuals in an organization

34
Q

QUALITY BY DESIGN (QbD APPROACH)

A

Quality is not an add-on

35
Q

QUALITY BY DESIGN (QbD APPROACH)

A

Product quality criteria must be established

36
Q

QUALITY BY DESIGN (QbD APPROACH)

A

Detailed specifications provide quantitative
parameters for measurement

37
Q

QUALITY BY DESIGN (QbD APPROACH)

A

Written procedures document how quality is
attained and maintained

38
Q

QUALITY BY DESIGN (QbD APPROACH)

A

Continuous monitoring to confirm quality is being built into the product

39
Q

ORGANIZATION OF QUALITY CONTROL

A

Quality Control Manager
- Materials Inspection Section
- Aanalytical Laboratory
- Biological Testing Laboratory
- Specifications & Analytical Development
- Quality Coordinating Office

40
Q

MATERIALS INSPECTION SECTION

A

To sample and examine all raw materials
received.

41
Q

MATERIALS INSPECTION SECTION

A

To sample and conduct physical tests on:
○ All shipments of packaging materials.
○ All manufacturing, filling, and packaging
operations

42
Q

ANALYTICAL LABORATORY

A

To assure the acceptability of a product, it is
essential that all materials are within specification

43
Q

ANALYTICAL LABORATORY

A

Tests are made not only to raw materials
and packaging components but also on
the bulk product during processing and
after packaging prior to its release to the
market

44
Q

BIOLOGICAL TESTING LABORATORY

A

To perform and evaluate microbiological and
pharmacological assays, sterility, pyrogen, and
bacteriological tests, irritation, safety, or acute
toxicity tests

45
Q

BIOLOGICAL TESTING LABORATORY

A

To conduct environmental monitoring

46
Q

SPECIFICATIONS AND ANALYTICAL
DEVELOPMENT

A

To coordinate with research, product
development, production sales and management towards improvement of a product.

47
Q

SPECIFICATIONS AND ANALYTICAL
DEVELOPMENT

A

To establish specifications for raw and packaging materials

48
Q

SPECIFICATIONS AND ANALYTICAL
DEVELOPMENT

A

To validate existing and tentative procedures of testing

49
Q
A
49
Q

SPECIFICATIONS AND ANALYTICAL
DEVELOPMENT

A

To establish specifications based on validated
procedures

49
Q

QUALITY COORDINATION OFFICE

A

To maintain and store records that represents the history of the batch from start to finish

49
Q

QUALITY COORDINATION OFFICE

A

These records include the batch and
master formula records, raw material
analytical records, printed and packaging
material inspection reports and retention
files

49
Q
A
50
Q

QUALITY COORDINATION OFFICE

A

To maintain and develop SOP’s.

Pharm Ana 1 LEC (5 decks)

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