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QC2 LECTURE > MODULE 7 > Flashcards

MODULE 7 Flashcards

1
Q

The activities of designing and
producing the container for a product.

A

PACKAGING

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2
Q

Types of packaging materials.

A

Primary packaging materials
Secondary packaging materials
Tertiary packaging materials

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3
Q

Types of packaging materials which do
not come in direct contact with the product and serve as accessory to
the primary packaging component.

A

Secondary packaging materials

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4
Q

Types of packaging materials that is used for bulk handling, warehouse storage and transport shipping

A

Tertiary packaging materials

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5
Q

Types of packaging materials which come in
direct contact with the product itself.

A

Primary packaging materials

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6
Q

Two types of special packaging.

A

Unit-dose packaging
Device packaging

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7
Q

This type of packaging permits easier administration by means of devices
such as pre-filled syringes, droppers, transdermal delivery systems, pumps
and aerosol sprays.

A

Device packaging

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8
Q

This packaging guarantees safer medication by reducing medication errors.

A

Unit-dose packaging

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9
Q

This packaging materials may be very useful in improving compliance with treatment.

A

Unit-dose packaging

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10
Q

Objectives of Packaging

A

Physical protection
Barrier protection
Containment or Agglomeration
Marketing
Security
Convenience
Portion control

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11
Q

The science, art and technology of
enclosing or protecting products for distribution, storage, sale, and use.

A

PACKAGING

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12
Q

The packaging and labels can be used by
marketers to encourage potential buyers to purchase the product.

A

MARKETING

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13
Q

This packaging objectives used to control usage.

A

Portion Control

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14
Q

Packages can have
features that add convenience in
distribution, handling, stacking, display, sale, opening, reclosing, use, dispensing, and reuse.

A

CONVENIENCE

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15
Q

Packages can be made with improved tamper resistance to deter tampering and also can have tamper evident features to help indicate tampering

A

SECURITY

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16
Q

Small objects are typically grouped together in
one package.

A

Containment or Agglomeration

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17
Q

A barrier from oxygen, water vapor, dust, etc., is often required

A

Barrier Protection

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18
Q

The objects
enclosed in the package may
require protection from, among
other things, shock, vibration, compression, temperature etc.

A

Physical Protection

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19
Q

They are subject to inspection by an experienced proofreader for graphical errors, for compliance with specifications as to
type and grade of stock printing quality and dimensional
tolerance.

A

Printed Materials

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20
Q

Label includes all written, printed or graphic
materials accompanying a product.

A

Printed Materials

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21
Q

Objectives of Labeling

A

Brand Identification
Description
Promotion

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22
Q

This labeling helps in
the identification and principal place of business of the person by or for whom the prepackaged product was
manufactured, processed, produced or
packaged for resale

A

Brand Identification

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23
Q

Labels provide the information regarding the product

A

DESCRIPTION

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24
Q

These labels help in promoting the product.

A

PROMOTION

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25
Q

Production control issues a packaging form that
carries the name of the product; item number;
lot number; number of labels, inserts and
packaging materials to be used; operations to be performed, and the quantity to be packaged

A

Labelling Control

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26
Q

Minimum requirements for package insert.

A
  1. Product name
  2. Strength or quantity of the active substance contained
    per unit dosage form
  3. Description
  4. Action
  5. Indication
  6. Contraindications
  7. Warnings & Precautions
  8. Caution
  9. Side effect
  10. Dosage and administration
  11. Overdosage
  12. How supplied
  13. Manufacturer/packer/distributor
  14. Business address
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27
Q

Minimum criteria for acceptance of printed
materials consists of:

A
  1. Text
  2. Color
  3. Size
  4. Thickness
  5. Grain direction
  6. Sealability
  7. Cleanliness
  8. Surface finish
  9. Adequate paste
  10. Shape
28
Q

The USP defines the container closure
system as the device that holds the drug and
is or maybe in direct contact with the drug.

A

CONTAINERS

29
Q

Criteria for the physical inspections of
container:

A
  1. Shape
  2. Volume
  3. Finish
  4. Opening
  5. Diameter
  6. Height
  7. Thickness
  8. Color
  9. Clarity
  10. Leak
  11. Torque
  12. Print
  13. Peeling
  14. Cleanliness
  15. Light transmission
  16. Stress crack resistance
30
Q

The physicochemical tests for the containers
include:

A
  1. Identification
  2. Infra-red properties
  3. Thermal analysis
  4. Extractable substance
  5. Non-volatile residue
  6. Water vapor permeation/transmission
  7. Moisture
  8. Resistance to water attack
31
Q

The integrity of the seal between the
closure and container depends on the
geometry of the two, the materials
used in their construction, the
composition of the cap liner and the
tightness with which the cap has been
applied.

A

Container and closure control

32
Q

Closure should fit the thread of the
container. It should sit on a container
without tilting, produce no leaks, should not
rotate continuously, be reasonably tight and
look elegant.

A

Container and closure control

33
Q

Chest tightness also known as ____________.

A

TORQUE TESTER

34
Q

The unit of force is in terms of ___________.

A

Inch pound

35
Q

Packaging operation checklist. (PRODUCT)

A
  1. Product mixed with another product
  2. Wrong product or strength
  3. Homogeneity
  4. Appearance/color/odor
  5. Contamination with foreign matter
  6. Fill/weight/volume
  7. Heat marks on product
  8. Freedom from chips, cracks
36
Q

Packaging operation checklist. (CONTAINERS)

A
  1. Freedom from cracks, chips
  2. Freedom from dents, distortions
  3. Contamination with foreign matter
  4. Leakage
  5. Fill/weight/volume
37
Q

Packaging operation checklist.(Strips/Pouches)

A
  1. Product name/strength
  2. Control code
  3. Expiration date
  4. Rx symbol
  5. Leakers in vacuum test
  6. Weak seal
  7. Empty or wrong count
  8. Torn strip of pouch
  9. Freedom from dust or smears
  10. Correct cutting
  11. Powder in pouches and seals
  12. Perforations of tear notches non-functional
  13. Fill/weight/volume
38
Q

Packaging operation checklist. (CLOSURES)

A
  1. Sealing lightness
  2. Freedom from dust/smears
  3. Crimping
  4. Correct design/colo
39
Q

Packaging operation checklist. (LABELS)

A
  1. Product name/strength
  2. Control code
  3. Expiration date
  4. Rx symbol
  5. Registration number
  6. Incorrect
  7. Glueing
  8. Alignment
  9. Torn/soiled
  10. Freedom from dust/smears
  11. Missing
40
Q

TYPES OF GLASS

A

TYPE 1 - Highly Resistant Borosilicate Glass
TYPE 2 - Treated Soda Lime Glass
TYPE 3 - SODA LIME
TYPE 4 - Sodalime Glass that is not suitable as container for Parenterals

41
Q

USP TEST FOR GLASS

A

TYPE 1 - Highly Resistant Borosilicate Glass
TYPE 2 - Treated Sodalime Glass
TYPE 3 - Sodalime Glass

42
Q

Types of Error in Experimental Data:

A

Random or Indeterminate Error
Systematic or Determinate Errors
Gross Errors

43
Q

2 Problems with Container

A

Leaching
Sorption

44
Q
  • These are errors that affects the
    precision of measurements.
  • An accidental and
    more or less intangible errors, over
    which the operator has little or any control.
A

Random or Indeterminate Error

45
Q

These are errors that affects the
accuracy of the results.
○ A tangible one,
the magnitude of which can be
determined or approximated.

A

Systematic or Determinate Error

46
Q

Sources of Systematic Errors

A

A. Instrumental Errors
B. Methodic Errors
C. Personal Errors

47
Q

Errors leads to outliers (results that appear to
differ markedly from all other data in a set of replicate
measurements.
○ It is usually occasional.
○ It is often large and may cause a result to be either high or low.

A

GROSS ERROR

48
Q

These result from
the carelessness,
inattention, or
personal limitations
of the analyst.

A

PERSONAL ERROR

49
Q

• These are the most common and the most
troublesome.
● These arise from nonideal chemical or
physical behavior of analytical systems.

A

METHODIC ERROR

50
Q

These errors are caused by
imperfections in measuring
devices and instabilities in
their power supplies

A

INSTRUMENTAL ERROR

51
Q

It has a definite value, an
assignable cause, and are of the same magnitude for replicate measurements made in the same way.
○ They lead to bias measurement technique

A

ERROR

52
Q

Systematic Errors may be either;

A

Constant or Proportional

53
Q

Systematic errors that decrease or increase in
proportion to the size of the sample

A

Proportional Error

54
Q

Systematic errors that are independent of the size of
the sample being analyze

A

Constant Error

55
Q

Quality Control Test for Plastics

A
  1. Leakage Test
  2. Collapsibility Test
  3. Clarity Aqueous Extract
  4. Water Vapor Permeability Test
  5. Transparency Test
  6. Biological Test
56
Q

Test is passed if no sign of leakage from container.

A

LEAKAGE TEST

57
Q

o Applicable to containers which are squeezed for
removing the contents

A

COLLAPSIBILITY TEST

58
Q

o Random selection of unlabeled, unmarked and non laminated
portions from suitable container

A

CLARITY AQUEOUS EXTRACT

59
Q

Acceptance criteria of Water Vapor Permiability test

A

NMT 0.2%

60
Q

2 test solutions used in TRANSPARENCY test

A

Hydrazine sulfate and Hexamine

61
Q

Types of Biological Test

A

❑Systemic Injection
❑Intra-cutaneous Test
❑Eye Irritation Test
❑Resistance to Stress

62
Q

Animals used in Systemic Injection test

A

ALBINO MICE

63
Q

Animals used in Intra-cutaneous and Eye irritation test.

A

RABBIT

64
Q

oAcceptance Criteria: No break, or deterioration should occur for the sample to pass the test.

A

Resistance to Stress

65
Q

Quality variation which is not confined within a
specific range; tolerance or limit, will grow to
uncontrollable magnitude and will encourage the
proliferation of errors, thus producing a defective
product.

A

ERRORS AND DEFECTS

66
Q

Tester used to check tightness of the container.

A

TORQUE TESTER

QC2 LECTURE (5 decks)

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