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Pharma Analysis I > Quality Control > Flashcards

Quality Control Flashcards

1
Q

Sum total of the organized arrangements made w/ the object of ensuring that products will be consistently of the quality required by their intended use

A

Quality Assurance

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2
Q

Totality of characteristics or features of a product that bear on its capacity to satisfy stated or implied needs
It is the combination of attributes or characteristics of a product which when compared to a standard, serves as a basis for reassuring the uniformity of the product and determines its degree of acceptability

A

Quality

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3
Q

Part of GMP concerned w/ sampling, specifications, testing organization, documentations, and release procedures.

A

Quality Control

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4
Q

Production of a drug or cosmetics of the HIGHEST STANDARD at the LOWEST COST

A

Goal

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5
Q

In manufacturing firm it is common

A
  • Financing
  • Production
  • QA/QC
  • Marketing
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6
Q

All manufacturing must be done in compliance _______________

A

w/ CURRENT GOOD MANUFACTURING PRACTICE or cGMP.

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7
Q

For this reason, _________________ is included in its Appendix

A

ADMINISTRATIVE ORDER NO. 220 S 1974

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8
Q

The Potential Benefits from QC System

A
  • The system minimizes or eliminates the risk of marketing unsafe products
  • It guarantees conformance to regulatory requirements
  • It guarantees product efficacy
  • It reduces operating costs
  • It reduces operating losses
  • It produces higher employee morale
  • It motivates the pharmaceutical and medical professionals to sell the product
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9
Q

Quality Assurance VS Quality Control

A

QA
- Describe the overall organizational body designed to assure the quality of the product

QC
- Function within the total control effort responsible for in-line or in-process testing

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10
Q

QA Functions

A
  • Testing & acceptance of only highly quality raw materials, representative samples.
  • IP tests against criteria
  • Monitors environmental conditions (depends on products)
  • Control packing components
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11
Q

3 Main Areas of QC (Analytical Test)

A
  • Raw Materials Quality Control
  • In - Process Quality Control
  • Finished Producy Quality Control
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12
Q

Volume fill
Detection of particles

A

In-Process Quality Control

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13
Q

ACTIVE INGREDIENT: ID TEST
SOLVENT: PYROGEN TEST
GLASS: WATER ATTACK/POWDERED GLASS TEST
RUBBER: DUROMETER TEST (also in plastics)

A

Raw Material Quality Control

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14
Q

Stability test
Leaker test
Sterility test

A

Finished Product Quality Control

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15
Q

Quality characteristics are interpreted by descriptive words and measurements however are subject to variation

A

Standards and Specifications

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16
Q

Quality variation, which is not confined within specific range, tolerance/limit will grow to uncontrollable magnitude and encourage _________

A

ERRORS

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17
Q

may be due to assignable cause such as materials, machines, methods and men

A

ERRORS

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18
Q

To avoid producing defective products, standards, and specifications are developed to serve as a basis for accepting or rejecting a product. These are some of the ff. points

A
  • Formula
  • Raw materials specification
  • Standard operating procedure
  • Finished product specification
  • Packaging material standard
  • Testing materials
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19
Q

concise and precise statement of the ingredients that comprise the product, together with the percentage and or the weight of each.

A

Formula

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20
Q

enumerate the characteristics of all the materials that go into the product and the permissible range of purity of each ingredient.

A

Raw materials specification

21
Q

step by step method on how to go about a job

A

Standard operating procedure

22
Q

cover of characteristics that affect the proper performance, purity, safety, and stability of the product

A

Finished product specification

23
Q

set of everything that goes around the product (ex. Bottles, cans, aluminum foil).

A

Packaging material standard

24
Q

Packaging must be considered with the following points in mind.

A
  • Units must run-on high-speed line
  • Involve complicated assembly
  • The package must be functional
  • Package must be completely compatible w/ the product
  • The package must protect the product and assure its stability
  • The package must ship well
25
Q

indispensable in ensuring conformity to

A

Testing materials

26
Q
  • Undesirable characteristics of a product
  • Failure to conform to specifications
A

Defects

27
Q

A unit of a product that contains one or more defects is called ___________

A

Defective

28
Q

Characteristics of Defect

A

ACCORDING TO MEASURABILITY
ACCORDING TO NATURE
ACCORDING TO SERIOUSNESS OR GRAVITY

29
Q

ACCORDING TO SERIOUSNESS OR GRAVITY

A

Minor defect
Major defect
Critical defect

30
Q

ACCORDING TO NATURE

A

Ocular defect
Internal defect
Performance defect

31
Q

ACCORDING TO MEASURABILITY

A

Attribute defect
Variable defect

32
Q

endanger life or property and may render the product non-functional

Examples: absence of warning label of a potent drug, disintegration time of one hour for an analgesic

A

Critical defect

33
Q

will not endanger life nor affect the function of product but still consider the product defective. Does not affect the efficacy of the drug.

Examples: slight deviation of color label from color standard

A

Minor defect

34
Q

affect the function of the product, rendering the product useless
Examples: cracks in the bottle

A

Major defect

35
Q

defect in function

Examples: suppository does not melt at body temp.

A

Performance defect

36
Q

visible

Example: contamination

A

Ocular defect

37
Q

not seen but present

Example: sub-potent drug

A

Internal defect

38
Q

measured dreadly by the instruments (objective)

Examples: length, weight, height, thickness, concentration, volume, viscosity, pH or size particles

A

Variable defect

39
Q

cannot be measured directly by instruments (subjective)

Examples: odor, visual examinations, clarity, sheen, cleanliness, smoothness, taste

A

Attribute defect

40
Q

Sources of Variation

A

MATERIALS
MACHINES
METHODS
MEN

41
Q
  • Variation between suppliers of same substance
  • Variation between batches from same supplier
  • Variation within batch
A

MATERIALS

42
Q

Inexact procedures
Inadequate procedures
Negligence by chance

A

METHODS

43
Q

Improper working conditions
Inadequate training, and understanding
Dishonesty, fatigue, and carelessness

A

MEN

44
Q

Variation of equipment for the same process
Difference in adjustment of equipment

A

MACHINES

45
Q

To sample and examine all raw materials received
To maintain periodic examination on quality of inventories
To perform an adult which is independent of the work done by production personnel
To sample and conduct physical tests on

A

Materials Inspection Section

46
Q
  • Protected from noise & vibration
  • Perform physical & chemical analysis (gravimetric and volumetric)
A

Analytical Laboratory

47
Q
  • Perform simple & complex microbiological procedures and biological interactions
  • Evaluate microbiological & pharmacological assays, sterility, pyrogen, and bacteriological tests, irrigation, safety or acute toxicity tests.
  • Conduct environmental monitoring
A

Biological Testing Laboratory

48
Q
  • To coordinate w/ research, product development, production sales, & management towards improvement of a product
    To establish specifications of raw and packaging materials
    To validate existing and tentative procedures of testing
    To establish specifications based on validated procedures
    To develop new assay methods for in-house use
    To develop and improve specifications for quality characteristics of the final product being manufactured
A

Specification & Analytical Development

49
Q

To maintain and store records that present the history of the batch from to start to finish
Furnish data will aid in analyzing product performance in the market
Investigate customer complaints or inquiries on product quality and toward feedback to sales organization
Call the attention of the appropriate development group any aspect in product development
Provide data that give scientific and legal status
Maintain and develop SOP

A

Quality Coordination Office

Pharma Analysis I (9 decks)

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