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Phar Review & Comprehensive Examination > Pharmaceutical Manufacturing > Flashcards

Pharmaceutical Manufacturing Flashcards

1
Q

Preparation, processing, packaging, repacking, labelling, changing of container, wrapping or label.

A

PHARMACEUTICAL MANUFACTURING

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2
Q

manufacturing that involves the production of Active Pharmaceutical Ingredients (APIs) and excipients?

a) Primary Manufacturing
b) Secondary Manufacturing
c) Tertiary Manufacturing
d) Toll Manufacturing

A

a) Primary Manufacturing

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3
Q

manufacturing that involves the production of finished dosage forms?

a) Primary Manufacturing
b) Secondary Manufacturing
c) Tertiary Manufacturing
d) Toll Manufacturing

A

b) Secondary Manufacturing

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4
Q

manufacturing that involves packaging, repacking, and labeling of bulk finished products?

a) Primary Manufacturing
b) Secondary Manufacturing
c) Tertiary Manufacturing
d) Toll Manufacturing

A

c) Tertiary Manufacturing

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5
Q

a toll manufacturing arrangement?

a) A manufacturing process that produces APIs and excipients.
b) A process where finished dosage forms are produced.
c) A packaging and labeling process for bulk finished products.
d) An arrangement where a competent company manufactures products for another company.

A

d) An arrangement where a competent company manufactures products for another company.

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6
Q

Specific quantity of product produced during a single manufacturing process

Batch
Lot
Batch/ Lot Number

A

Batch

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7
Q

Specific portion of batch

Batch
Lot
Batch/ Lot Number

A

Lot

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8
Q

For identification and traceability of a single batch/ lot

Batch
Lot
Batch/ Lot Number

A

Batch/ Lot Number

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9
Q

Contains formulation, manufacturing procedures,
specifications, QA requirements, and labeling of a finished
product Master Batch Record or Batch Manufacturing

Master Formula
Batch Manufacturing Record (BMR)
Standard Operating Procedures (SOPs)
Manufacturing Order

A

Master Formula

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10
Q

Ensures that batches were properly made and QC tests were performed; also includes the actual yield

Master Formula
Batch Manufacturing Record (BMR)
Standard Operating Procedures (SOPs)
Manufacturing Order

A

Batch Manufacturing Record (BMR)

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11
Q

Step-by-step instruction for performing an operational task or activity

Master Formula
Batch Manufacturing Record (BMR)
Standard Operating Procedures (SOPs)
Manufacturing Order

A

Standard Operating Procedures (SOPs)

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12
Q

Give instructions to production department to produce product

Master Formula
Batch Manufacturing Record (BMR)
Standard Operating Procedures (SOPs)
Manufacturing Order

A

Manufacturing Order

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13
Q

Addition of API in an unstable preparation to compensate for loss during manufacture

A

Overaging

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14
Q

Designated area for holding of incoming components prior to acceptance testing and qualification for use

A

Quarantine

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15
Q

Yellow label

‘under quarantine’
‘approved’
‘rejected’

A

‘under quarantine’

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16
Q

Green label

‘under quarantine’
‘approved’
‘rejected’

A

‘approved’

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17
Q

Red label

‘under quarantine’
‘approved’
‘rejected’

A

‘rejected’

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18
Q

Documented evidence that a system does what it is
supposed to do for consistency and quality)

A

validation

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19
Q

Formulates new or reformulates existing products.
Facilities: Library, lab, animal house, pilot plant

Research and Development
Production Department
Quality Assurance Department
Quality Control Department

A

Research and Development

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20
Q

Activities: Manufacturing, warehousing (including inventory
control), and storage

Research and Development
Production Department
Quality Assurance Department
Quality Control Department

A

Production Department

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21
Q

Assures that all operations meet the required standards for safety and efficacy; ensures compliance to CGMP; conducts
quality audit and monitoring; cooperates with regulatory agencies; prepares SOPS.

Research and Development
Production Department
Quality Assurance Department
Quality Control Department

A

Quality Assurance Department

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22
Q

Heart and soul of drug manufacturing; tests compliance of raw materials, packaging materials, In-process, and finished products (via inspection and assay); also conducts sampling and environmental testing

Research and Development
Production Department
Quality Assurance Department
Quality Control Department

A

Quality Control Department

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23
Q

Promotion and advertisement

Marketing Department
Regulatory Department
Engineering Department
Medical Department

A

Marketing Department

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24
Q

Ensures compliance with all pertinent laws and regulations (LTO and FDA registration, Batch certification of biologicals)

Marketing Department
Regulatory Department
Engineering Department
Medical Department

A

Regulatory Department

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25
Q

Locates, installs, repair, maintains equipment. Ensures plan and personnel.

Marketing Department
Regulatory Department
Engineering Department
Medical Department

A

Engineering Department

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26
Q

Physical and medical examination of employees and
applicants

Marketing Department
Regulatory Department
Engineering Department
Medical Department

A

Medical Department

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27
Q

Acquires and distributes raw materials or finished products on a wholesale basis

Drug Trader
Drug Importer
Drug Exporter
Drug Wholesaler
Drug Manufacturer

A

Drug Wholesaler

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28
Q

Distribute raw materials of finished products to other countries

Drug Trader
Drug Importer
Drug Exporter
Drug Wholesaler
Drug Manufacturer

A

Drug Exporter

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29
Q

Responsible for Drug production

Drug Trader
Drug Importer
Drug Exporter
Drug Wholesaler
Drug Manufacturer

A

Drug Manufacturer

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30
Q

Registered owner of drug product but subcontracts to toll manufacturer

Drug Trader
Drug Importer
Drug Exporter
Drug Wholesaler
Drug Manufacturer

A

Drug Trader

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31
Q

Distribute raw materials or finished products from other countries to other outlets

Drug Trader
Drug Importer
Drug Exporter
Drug Wholesaler
Drug Manufacturer

A

Drug Importer

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32
Q

temperature range for storage in a freezer?

a) -10 to 2 °C
b) 2 to 8 °C
c) -20 to -10 °C
d) 8 to 10 °C

A

c) -20 to -10 °C

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33
Q

ideal temperature range for storage in a refrigerator?

a) -10 to 2 °C
b) 2 to 8 °C
c) -20 to -10 °C
d) 8 to 10 °C

A

b) 2 to 8 °C

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34
Q

cold storage condition

a) -10 to 2 °C
b) 2 to 8 °C
c) -20 to -10 °C
d) NMT 8 °C

A

d) NMT 8 °C

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35
Q

cool condition

a) -10 to 2 °C
b) 2 to 8 °C
c) 8 to 15 °C
d) NMT 8 °C

A

c) 8 to 15 °C

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36
Q

prevailing temperature in the work area

A

Room Temperature

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37
Q

Controlled RT

20 to 25 °C
30 to 40 °C
>40 °C

A

20 to 25 °C

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38
Q

Warm Area

20 to 25 °C
30 to 40 °C
>40 °C

A

30 to 40 °C

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39
Q

Excessive heat

20 to 25 °C
30 to 40 °C
>40 °C

A

> 40 °C

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40
Q

Immediate container; has direct product contact; affects stability; may provide means of administration. Ex. Bottles, caps, cap liners, filler, desiccant

Primary Packaging
Secondary Packaging
Tertiary Packaging

A

Primary Packaging

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41
Q

Outer packaging; encloses primary packaging; optional. Ex. Pallets, shippers, carton box, conjugated box, label, inserts

Primary Packaging
Secondary Packaging
Tertiary Packaging

A

Secondary Packaging

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42
Q

encloses secondary packaging. Ex. Large boxes

Primary Packaging
Secondary Packaging
Tertiary Packaging

A

Tertiary Packaging

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43
Q

Impervious to air or any other gas

A

Hermetic packaging

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44
Q

contains Indicator in case of breach. seals are applied to the packaging in such a way that any attempt to open or tamper with the package will cause visible damage or alteration to the seal.

A

Tamper-resistant

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45
Q

less subject to thermal stress. Used for aqueous non-buffer solutions

Type 1: Ultra-resistant borosilicate glass
Type 2: Treated Soda-lime glass
Type 3: Regular soda-lime glass
Type 4/NP: General purpose soda-lime glass

A

Type 1: Ultra-resistant borosilicate glass

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46
Q

not resistant to leeching, high temp, chemical attack

Type 1: Ultra-resistant borosilicate glass
Type 2: Treated Soda-lime glass
Type 3: Regular soda-lime glass
Type 4/NP: General purpose soda-lime glass

A

Type 3: Regular soda-lime glass

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47
Q

suitable for acid and neutral preparations both for parental and other use.

Type 1: Ultra-resistant borosilicate glass
Type 2: Treated Soda-lime glass
Type 3: Regular soda-lime glass
Type 4/NP: General purpose soda-lime glass

A

Type 2: Treated Soda-lime glass

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48
Q

low hydrolytic resistance; for oral and topical use preparatins

Type 1: Ultra-resistant borosilicate glass
Type 2: Treated Soda-lime glass
Type 3: Regular soda-lime glass
Type 4/NP: General purpose soda-lime glass

A

Type 4/NP: General purpose soda-lime glass

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49
Q

Non-autoclavable

Polypropylene (PP)
Polyethylene (PE)
Thermoplastic
Thermoset

A

Polyethylene (PE)

50
Q

For mineral water or beverage bottles, MOST COMMONLY USED

Low-density PE (LDPE)
PE Terephthalate (PET)
High-density PE (HDPE)
Polyvinyl Chloride (PVC)

A

PE Terephthalate (PET)

51
Q

Hard thermoset; for solid dosage forms

Low-density PE (LDPE)
PE Terephthalate (PET)
High-density PE (HDPE)
Polyvinyl Chloride (PVC)

A

High-density PE (HDPE)

52
Q

Flexible; for squeeze bottles, sprays bottles, and medicine
droppers

Low-density PE (LDPE)
PE Terephthalate (PET)
High-density PE (HDPE)
Polyvinyl Chloride (PVC)

A

Low-density PE (LDPE)

53
Q

Least resistant to permeation; for blister packs

Low-density PE (LDPE)
PE Terephthalate (PET)
High-density PE (HDPE)
Polyvinyl Chloride (PVC)

A

Polyvinyl Chloride (PVC)

54
Q

High temperature resistance; for autoclavable plastics

Polypropylene (PP)
Polyethylene (PE)
Thermoplastic
Thermoset

A

Polypropylene (PP)

55
Q

Soft: flexible and squeezable

Polypropylene (PP)
Polyethylene (PE)
Thermoplastic
Thermoset

A

Thermoplastic

56
Q

Hard: firm or rigid

Polypropylene (PP)
Polyethylene (PE)
Thermoplastic
Thermoset

A

Thermoset

57
Q

Flexibility, heat-sealability

A

Foils

58
Q

Contains isoprene or neoprene

A

Rubber

59
Q

Aluminum, tin, stainless steel

A

Metal

60
Q

◆ Cannot be resealed once opened
◆ No antimicrobial agent
◆ Water for injection or sterile water for injection
◆ USP Limit: 1 Liter

Single-dose container/Multiple-unit container

A

Single-dose container

61
Q

◆ Can be resealed once opened
◆ Has antimicrobial agent
◆ Bacteriostatic water for injection
◆ USP Limit: 30 ml

ingle-dose container/Multiple-unit container

A

Multiple-unit container

62
Q

Protection from extraneous solids.

A

Well-closed container

63
Q

Protection from solids, liquids and vapors

A

Tight container

64
Q

Protection from phytochemical deterioration

A

Light-resistant container

65
Q

PRINCIPAL DISPLAY PANEL

A

40%

66
Q

Widely used because of its physiological compatibility, lack of toxicity and high dielectric constant.

A

Water

67
Q

alternation of the polarity of solvent decreasing dielectric constant by the addition of another solvent that is both miscible with water and in which the compound is soluble.

A

Cosolvency

68
Q

solubility of a weak base is increased by decreasing the pH; solubility of weak acid is increased by increasing the
pH;

A

Control of pH

69
Q

may enhanced solubility but may cause a decrease in the activity.

Chemical modification
Complexation
Micellation

A

Chemical modification

70
Q

leads to the formation of soluble intramolecular complex which Is usually macromolecular

Chemical modification
Complexation
Micellation

A

Complexation

71
Q

spontaneous passage of poorly water soluble solute molecules into an aqueous solution of a soap or a detergent in which a thermodynamically stable solution Is formed.

Chemical modification
Complexation
Micellation

A

Micellation

72
Q

for dimercaprolin

A

arachis oil

73
Q

for miconazole eye drops and triamcinotone ear drops;

A

castor oil

74
Q

alcohol limit for children under 6 yrs old

0.5%
5%
10%

A

0.5%

75
Q

alcohol limit for children between 6-12 yrs old

0.5%
5%
10%

A

5%

76
Q

alcohol limit for children over 12 yrs old

0.5%
5%
10%

A

10%

77
Q

clear, syrup liquid; with sweet taste; miscible with water and alcohol

Dimethyl Sulphoxide
Propylene Glycol
Liquid Paraffin
Glycerol

A

Glycerol

78
Q

viscous fluid miscible with water and alcohol;

Dimethyl Sulphoxide
Propylene Glycol
Liquid Paraffin
Glycerol

A

Propylene Glycol

79
Q

polar that is thought to aid in the penetration of drug
(idoxuridine) through the skin

Dimethyl Sulphoxide
Propylene Glycol
Liquid Paraffin
Glycerol

A

Dimethyl Sulphoxide

80
Q

mineral oil; thus used for topical preparation in emulsion form;

Dimethyl Sulphoxide
Propylene Glycol
Liquid Paraffin
Glycerol

A

Liquid Paraffin

81
Q

solvents for cosmetics

Xylene
Glycofurol
Isopropyl myristate & isopropyl palmitate

A

Isopropyl myristate & isopropyl palmitate

82
Q

solvents for ear drops to dissolve earwax

Xylene
Glycofurol
Isopropyl myristate & isopropyl palmitate

A

Xylene

83
Q

solvents for parenteral products

Xylene
Glycofurol
Isopropyl myristate & isopropyl palmitate

A

Glycofurol

84
Q

added to resist change in the pH of the preparation; important to maintain pH

Chelating Agents
Preservatives
Buffers
Antioxidants

A

Buffers

85
Q

provide electrons and easily available hydrogen atoms that are accepted more readily by the free radicals; involve in quenching (delay or retard oxidation by rapidly reacting with free radicals as they are formed)

Chelating Agents
Preservatives
Buffers
Antioxidants

A

Antioxidants

86
Q

Sulfites, hydrophosphorous acids, and ascorbic acid

A

for aqueous solutions

87
Q

BHT BHA, alpha-tocopherois, ascorbyl palmitate

A

for oleaginous preparation

88
Q

complex or bind the metals to make them unavailable for participation in the oxidative process; calcium disodium edetate or EDTA

Chelating Agents
Preservatives
Buffers
Antioxidants

A

Chelating Agents

89
Q

prevent the growth of microorganism

Chelating Agents
Preservatives
Buffers
Antioxidants

A

Preservatives

90
Q

Aspartame; from Methyl ester dipeptide and aspartic acid

180-200

A

180-200 relative sweetnes

91
Q

Saccharin from Phthalic anhydride a petroleum product

A

300 relative sweetnes

92
Q

Sodium Cyclamate from Sulfonation of cyclohexylanine

A

30 relative sweetnes

93
Q

Apricot, butterscotch, liquorice, peach, vanilla, maple, wintergreen

A

Salty

94
Q

Anise, chocolate, mint, passion fruit, wild cherry, walnut

A

Bitter

95
Q

Vanilla, fruits, berries

A

Sweet

96
Q

Citrus fruits, liquorice, raspberry, root beet

A

Sour

97
Q

Grape, lemon lime, barberry

A

Metallic

98
Q

Alkaline, chocolate, cream, vanilla, mint combination

A

Alkaline

99
Q

(water-soluble)

A

dyes

100
Q

(water insoluble)

A

lakes

101
Q

Acacia, bentonite, tragacanth , alginates, xanthan gum, cellulose derivates

A

as suspending agent; produce deflocculated system at low
concentrations

102
Q

inorganic used to alter zeta potential;

A

electrolytes

103
Q

added to form tablets of a suitable size for handling

A

Filler (diluent)

104
Q

added to drug filler mixture to ensure that granules and tablets can be formed with the required mechanical strength

A

Binder (adhesive)

105
Q

to ensure that the tablet, when in contact with liquid, breaks up into small fragments, which promotes rapid drug dissolution

A

Disintegrant

106
Q

to improve flowability of the powder

A

Glidant

107
Q

to ensure that the tablet formation and ejection can occur with low friction between the solid and the die wall

A

Lubricant

108
Q

for oils or oil drug solutions to compacted into tablets; microcrystalline cellulose and silica

A

Sorbents

109
Q

to produce flexibility and elasticity of the coating and thus provide durability; 20-30%; glycerol, sorbitol, PEG, propylene glycol, diethyl phthalate, dibutyl subacetate, castor

A

Plasticizers

110
Q

titanium dioxide; water gel

A

Opacifiers

111
Q

to produce smooth, thin films reproducible under conventional coating conditions; cellulose acetate phthalate, HPMC, hydroxypropyl cellulose, methyl cellulose

A

Film Former

112
Q

to provide luster to the tablet without a separate polishing operation; beeswax, carnauba wax

A

Glossant

113
Q

oleaginous bases; with emollient effects; effective as occlusive dressings; difficult to wash off; limited amount of water and aqueous preparations may be incorporate
◆ Petrolatum
◆ White petrolatum
◆ White ointment
◆ Yellow ointment

A

Hydrocarbon Bases

114
Q

→ Those that permit the incorporation of aqueous solutions resulting in the formation of w/o
emulsion; hydrophilic petrolatum
→ Those that are w/o emulsions and permit incorporation of additional quantities of aqueous
solutions; Lanolin

A

Absorption Bases

115
Q

o/w emulsions resembling creams; easily washed; may be dilute with water or aqueous solutions, have the ability to absorb serous discharges; hydrophilic ointment. completely water washable; no oil; greaseless; not used to incorporate aqueous solutions; polyethylene glycol

A

Water Removal Bases

116
Q

hydrogenated fatty acids of vegetable oils; glyceryl monostearate and glyceryl monopalminate

A

Fatty or Oleaginous Bases

117
Q

melts between 30-60°C ; exhibit polymorphism; B form is stable; phenol and chloral hydrate may lower the melting point thus solidifying agents like cetyl ester wax (20%) or beeswax (4%) may be added

A

Cocoa Butter

118
Q

triglycerides from palm, palm kernel and coconut oils with self-emulsifying glyceryl monostearate and polyoxyl stearate

A

Fattibase

119
Q

triglycerides of saturated fatty acids C12 – C18 with varied portions of the corresponding partial glyceride

A

Witepsol Bases

120
Q

to reduce adhesion or sticking between the powder and the punch face

A

Anti-adherent

Phar Review & Comprehensive Examination (17 decks)

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