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QC2 LECTURE > MODULE 7 > Flashcards

MODULE 7 Flashcards

(66 cards)

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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
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
Labelling Control
26
Minimum requirements for package insert.
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
27
Minimum criteria for acceptance of printed materials consists of:
1. Text 2. Color 3. Size 4. Thickness 5. Grain direction 6. Sealability 7. Cleanliness 8. Surface finish 9. Adequate paste 10. Shape
28
The USP defines the container closure system as the device that holds the drug and is or maybe in direct contact with the drug.
CONTAINERS
29
Criteria for the physical inspections of container:
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
The physicochemical tests for the containers include:
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
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.
Container and closure control
32
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.
Container and closure control
33
Chest tightness also known as ____________.
TORQUE TESTER
34
The unit of force is in terms of ___________.
Inch pound
35
Packaging operation checklist. (PRODUCT)
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
Packaging operation checklist. (CONTAINERS)
1. Freedom from cracks, chips 2. Freedom from dents, distortions 3. Contamination with foreign matter 4. Leakage 5. Fill/weight/volume
37
Packaging operation checklist.(Strips/Pouches)
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
Packaging operation checklist. (CLOSURES)
1. Sealing lightness 2. Freedom from dust/smears 3. Crimping 4. Correct design/colo
39
Packaging operation checklist. (LABELS)
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
TYPES OF GLASS
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
USP TEST FOR GLASS
TYPE 1 - Highly Resistant Borosilicate Glass TYPE 2 - Treated Sodalime Glass TYPE 3 - Sodalime Glass
42
Types of Error in Experimental Data:
Random or Indeterminate Error Systematic or Determinate Errors Gross Errors
43
2 Problems with Container
Leaching Sorption
44
- 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.
Random or Indeterminate Error
45
These are errors that affects the accuracy of the results. ○ A tangible one, the magnitude of which can be determined or approximated.
Systematic or Determinate Error
46
Sources of Systematic Errors
A. Instrumental Errors B. Methodic Errors C. Personal Errors
47
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.
GROSS ERROR
48
These result from the carelessness, inattention, or personal limitations of the analyst.
PERSONAL ERROR
49
• These are the most common and the most troublesome. ● These arise from nonideal chemical or physical behavior of analytical systems.
METHODIC ERROR
50
These errors are caused by imperfections in measuring devices and instabilities in their power supplies
INSTRUMENTAL ERROR
51
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
ERROR
52
Systematic Errors may be either;
Constant or Proportional
53
Systematic errors that decrease or increase in proportion to the size of the sample
Proportional Error
54
Systematic errors that are independent of the size of the sample being analyze
Constant Error
55
Quality Control Test for Plastics
1. Leakage Test 2. Collapsibility Test 3. Clarity Aqueous Extract 4. Water Vapor Permeability Test 5. Transparency Test 6. Biological Test
56
Test is passed if no sign of leakage from container.
LEAKAGE TEST
57
o Applicable to containers which are squeezed for removing the contents
COLLAPSIBILITY TEST
58
o Random selection of unlabeled, unmarked and non laminated portions from suitable container
CLARITY AQUEOUS EXTRACT
59
Acceptance criteria of Water Vapor Permiability test
NMT 0.2%
60
2 test solutions used in TRANSPARENCY test
Hydrazine sulfate and Hexamine
61
Types of Biological Test
❑Systemic Injection ❑Intra-cutaneous Test ❑Eye Irritation Test ❑Resistance to Stress
62
Animals used in Systemic Injection test
ALBINO MICE
63
Animals used in Intra-cutaneous and Eye irritation test.
RABBIT
64
oAcceptance Criteria: No break, or deterioration should occur for the sample to pass the test.
Resistance to Stress
65
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.
ERRORS AND DEFECTS
66
Tester used to check tightness of the container.
TORQUE TESTER

QC2 LECTURE (5 decks)

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