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MANU > summary > Flashcards

summary Flashcards

1
Q

large-scale production of drug products’ preparation, processing, packaging, labeling, repacking, changing wrapper, label or container of any drug products

A

manufacturing

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2
Q

Stages of Manufacturing

A
  • Dispensing of Raw Materials
  • Processing of Dosage Forms
  • Filling
  • Packaging and Repacking
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3
Q

manufacture of raw material (APIs and
Excipients)

A

Primary Manufacturing

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4
Q

manufacture of finished dosage form

A

Secondary Manufacturing

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5
Q

packaging, labeling, and repacking of bulk finished product

A

Tertiary Manufacturing

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6
Q

an arrangement whereby a competent company manufactures products for another company

A

Toll Manufacturing

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7
Q

Revised Regulations for the Licensing of Drug Establishments and outlets

A

AO 56 s.1989

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8
Q

Rules and Regulations on the Licensing of Establishments Engaged in the Manufacture, Conduct of Clinical Trial, Distribution, Importation, Exportation, and Retailing of Drug Products, and Issuance of Other Related Authorization

A

AO 2014-0034

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9
Q

involved in production of drugs products (preparatory processing, compounding, formulating, filling, packaging, repackaging, altering, ornamenting, finishing, labeling)

A

Manufacturer

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10
Q

involved in packaging of bulk drug product to its immediate container

A

Packer

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11
Q

involved in repackaging of finished product into smaller quantities in a separate container and/ or secondary packaging

A

Repacker

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12
Q

Registered owner of drug product and formulation but subcontracts manufacturing

A

Trader

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13
Q
  • Procures RM and PM
  • Provides monographs and QC protocols
A

Trader

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14
Q

Drug Manufacturers:

A

Manufacturer
Packer
Repacker
Trader

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15
Q

imports RM, API, and/or finished products for wholesale distribution to other licensed established

A

Importer

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16
Q

exports RM, API, and/ or finished products for wholesale distribution to establishments outside the country

A

Exporter

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17
Q

procures RM, API, and/ or finished products from a local licensed establishment for local distribution in wholesale basis

A

Wholesaler

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18
Q

Drug Distributors

A

Importer
Exporter
Wholesaler

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19
Q

• formulates new products

• involved in process development and scale-up

• prepares Master formula

A

Research and Development Dept

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20
Q

Stages of Drug Development

A

1) Discovery and Development
2) Preclinical Research
3) Clinical Research
4) FDA Review
5) Post-market Surveillance

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21
Q

contains the formulation, specifications, manufacturing procedures, QA requirements, and labeling of a finished product

A

Master formula

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22
Q

addition of an excess amount of API in an unstable preparation

A

Overages

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23
Q

• prepares Master formula
• justifies overages in the formula

A

Research and Development Dept

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24
Q

• deals with all stages of manufacturing batches of finished drug products

• Plans the production according to MO

A

Production Dept

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25
Q

specific quantity of product intended to have uniform character and quality, produced during the same single cycle of manufacture

A

Batch

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26
Q

specific identified portion of a batch

A

Lot

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27
Q

gives instructions to manufacture a product

A

Manufacturing Order (MO)

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28
Q

• accomplish the BMR to ensure that batches were properly made and tests were conducted

A

Production Dept

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29
Q

document containing the details of the manufacture of each batch

A

Batch Manufacturing Record (BMR)

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30
Q

• stores materials and finished products

• holds incoming components in the quarantine area

• involved in purchasing and logistics

A

Warehouse Dept

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31
Q

status of materials which are isolated physically while a decision is awaited on their release, rejection, or reprocessing

A

Quarantine

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32
Q

• assures that all operations meet required standards for safety and efficacy, ensures compliance to cGMP

• conducts quality audit and monitoring

• prepares SOPs

A

Quality Assurance Dept

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33
Q

step-by- step instructions for performing operational tasks or activities

A

Standard Operating Procedures (SOP)

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34
Q

• tests compliance of raw materials, packaging materials, and finished products to specifications

• conducts sampling of materials to be tested

• performs IPQC and environmental testing

A

Quality Control Dept

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35
Q

• studies current market trends, consumer behavior and product status in market
• promote and advertisement

A

Marketing Department

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36
Q

ensures compliance of company and its products with all pertinent regulations and laws about drugs and their marketing

A

Regulatory Dept

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37
Q

• installs, maintains and repairs of equipment and premises
• conducts validation and qualification
• ensures safety

A

Engineering Department

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38
Q

action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results

A

Validation

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39
Q

action of proving that premises, systems or equipment work correctly and actually lead to expected results

A

Qualification

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40
Q

• concerned with physical examination and medical treatment of employees
• performs clinical studies
• publishes house organ/paper

A

Medical Dept

41
Q

• inert substance added to increase tablet size or fill the capsule body

A

Diluent (Filler/ Bulking Agent)

42
Q

• Most common diluent
• No reaction with most drugs
• Monohydrate, anhydrous, and spray-dried

43
Q

• Used as sweetener

A

Sucrose and Dextrose

44
Q

• Good flow and very compressible
• Disintegrates rapidly in water

A

Microcrystalline Cellulose (Avicel®)

45
Q

• Used as diluent, binder and disintegrant

46
Q

• Only inorganic salt used as diluent

A

Dibasic calcium Phosphate

47
Q

• Used in chewable tablet s
• Negative heat of solution

A

Mannitol and xylitol

48
Q

• Imparts cohesiveness to powders causing them to from granules

49
Q

• Binder of choice for wet gran

A

Starch Paste

50
Q

• Natural guns

A

Acacia & Tragacanth

51
Q

• an economic way of protecting, preparing, identifying, and containing the drug products
• composed of container and closure

52
Q

• in direct contact with product
• immediate container
• affects stability
• may provide means of administration

A

Primary Packaging

53
Q

Examples of Primary Packaging

A

bottles, caps, liners, filler, desiccant

54
Q

• outer packaging (not always present)
• encloses primary packaging

A

Secondary Packaging

55
Q

Examples of Secondary Packaging

A

carton box, sticker label, inserts, conjugated box

56
Q

Types of Packaging

A

Primary
Secondary

57
Q

• protects content from extraneous solids

A

Well-closed

58
Q

• protects contents from extraneous solids, liquids, and vapors
• protects from deliquescence, efflorescence, evaporation

59
Q

• impervious to air or any other gas

60
Q

• protects from photochemical degradation

• amber bottles

A

Light-Resistant

61
Q

• difficult for children under 5 years of age to open

• press down and turn 1.
• squeeze and turn
• alight the arrows
• latch top

A

Child-Resistant

62
Q

• uses an indicator which if breached or missing can provide evidence that tampering has occurred

A

Tamper-resistant

63
Q

• shrink seal/ wrap
• breakable caps
• tape seal
• bottle seal
• aerosol

A

Tamper-resistant

64
Q

only true temper-resistant packaging

65
Q

Containers According to Protection Ability

A

• Well-closed
• Tight
• Hermetic
• Light-Resistant
• Child-resistant
• Tamper-resistant

66
Q

• contains a single dose only and packaged in non- resealable containers

• no antimicrobial agent; water: WFI or SWFI; USP limit: 1000 mL

• ampoules, prefilled syringes

A

Single Unit

67
Q

Advantages of Single Unit container

A
  • low cost
  • not breakable
  • light weight
  • chemically inert
68
Q

Disadvantages of single unit container

A
  • permeable
  • low heat resistance
  • not as clear as glass
  • poor physical stability
69
Q

• contains multiple doses and packaged in resealable containers
• with antimicrobial agent; water: BWFI; USP limit: 30 mL
• vials

A

Multiple unit

70
Q

• most widely used, made up of inorganic compounds (major component: SiO2)

71
Q

Advantages of Glass

A
  • rigid and transparent
  • impermeable
  • chemically resistant
  • can be easily sterilized
72
Q

Disadvantages of Glass

A
  • high cost
  • fragile
  • relatively heavy
  • prone to leaching
73
Q

• organic polymers of HMW

74
Q

Types of Glass

A

• Highly Resistant Borosilicate (Pyrex, Borosil)
• Treated Soda Lime Glass
• Soda Lime Glass
• General Soda Lime Glass

75
Q

soft when heated and hard when cooled; flexible and squeezable

A

Thermoplastic

76
Q

permanently hard; rigid

77
Q

Types of Plastic

A

Thermoplastic
Thermoset

78
Q

decrease coefficient of expansion

79
Q

Types of Polymers for Plastic

A

• Polyethylene Terephthalate
• High-density Polyethylene
• Polyvinyl Chloride
• Low-density Polyethylene
• Polypropylene

80
Q

used for beverages

A

Polyethylene Terephthalate

81
Q

hard thermoset for solid dosage forms

A

High Density Polyethylene

82
Q

used for blister packs

A

Polyvinyl Chloride

83
Q

thermoplastic for squeeze bottles and medicine droppers

A

Low-density Polyethylene

84
Q

used for autoclave containers

A

Polypropylene

85
Q

Used in aerosol cans and collapsible tubes

86
Q

• Used in blister packs and strip packs

A

Foils, Films and Laminates

87
Q

• Used in vial stoppers and syringe plugs

88
Q

• Used in vial stoppers and syringe plugs

89
Q

Storage Condition: Cold

A

NMT 2 to 8°C

90
Q

Refrigerator SC

A

2 to 8 degrees C

91
Q

Freezer SC

A

-20 to -10°C

92
Q

Cool SC

A

8 to 15°C

93
Q

Cool SC

A

8 to 15°C

94
Q

Room Temperature SC

A

temperature prevailing in the area

95
Q

Controlled Room Temperature

A

20 to 25°C

96
Q

Warm SC

A

30 to 40°C

97
Q

Controlled Room Temperature

A

20 to 25°C

98
Q

used for divided powders

99
Q

Excessive Heat

MANU (13 decks)

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