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manufacturing
100問 • 1年前
  • Hannah Angelique Losaria
    • 通報

    問題一覧

  • 1

    large scale production of drug products' preparation, processing, packaging, labeling, repacking, chamging wrapper, label or container of any drug products

    manufacturing

  • 2

    manufacturing of APIs and exipients

    primary manfacturing

  • 3

    manufacture of finished dosage form

    seondary

  • 4

    packing, labeling, and repacking of bulk finished products

    tertiary

  • 5

    an arrangement whereby a competent company manufactures for another compnay

    toll

  • 6

    formulates new products; reformulates new products, does chemical, pharmaceutical and physiological research

    research and development department

  • 7

    manufactures products according to schedule; warehousing (inventory control) and storage

    production department

  • 8

    assures that all operations meet required standards for safety and efficacy; ensures compliance to cGMP; prepares SOPs

    QA department

  • 9

    test compliance of raw materials, packaging materials, and fnished products; conducts sampling of materials to be tested; performs IPQC and environmental testing

    QC department

  • 10

    specific quantity of products itended to have uniform character an dquality produced during a single manufacturing process

    batch

  • 11

    specific identified portion of a batch

    lot

  • 12

    for identification and traceability of a single batch

    batch number

  • 13

    contains formulation, manufacturing procedures, specifications, QA requirements, and labeling of finihsed products

    master formula

  • 14

    ensures that batches were properly made and qc tests were perormed; actual yield

    master bach record/ batch manufacturing record

  • 15

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

    SOP

  • 16

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

    overage

  • 17

    color of quarantined products

    yellow

  • 18

    color of approved products

    green

  • 19

    color of rejected products

    red

  • 20

    documented evidence that a system does what it is supposed to do

    validation

  • 21

    an economic way of protecting, preparing, identifing, an contaning prducts

    packaging

  • 22

    protects content from extraneous solids

    protects content from extraneous solids

  • 23

    protects content from extraneous solids, liqids, and vapors; protects from delinquescence, effflorescence, evaporation

    tight

  • 24

    impprevious to air or any other gas

    hermetic

  • 25

    type I glass: with boric acid; high resistance; for buffered and non buffered aqueous parenteral solution

    highly resistante borosilicate glass

  • 26

    type II glass surface is treated with SO2; dealkalized; for buffered acidic non aqueous solutions

    treated soda lme glass

  • 27

    type III glass low resistance; for reconstituted dry solids and non aqueous liquids

    soda llime glass

  • 28

    orgnic polymers of HMW

    plastic

  • 29

    type of plastic that is soft when heated and hard when cooled; flexible and squeezable

    thermoplastic

  • 30

    for beverages

    1. polyethylene terephthalate

  • 31

    hard thermoset for solid dosage froms

    2. high density polyethylene

  • 32

    for blister packs

    3. polyvinyl chloride

  • 33

    high temperature resistance

    5. polypropylene

  • 34

    display of written, printed, or graphic matter on immediate conatiner

    label

  • 35

    cold

    NMT 2-8

  • 36

    freezer

    -10 to -20

  • 37

    refrigerator

    2-8

  • 38

    cool

    8-15

  • 39

    controlled room temperature

    20-25

  • 40

    warm

    30-40

  • 41

    innert substance added to increase tablet size which is practical for compression

    diluent/filler

  • 42

    imparts cohesiveness to powders causing them to form granules

    binders

  • 43

    hydrophobic powders added prior to compression to reduce friction and improve flow properties

    antifrictions/flow activators

  • 44

    reduces sticking to punch faces or die walls

    anti adherent

  • 45

    blue no.1

    brilliant blue FCF

  • 46

    blue no.2

    indigoitne

  • 47

    green no.3

    fast green FCF

  • 48

    red no.3

    erythrosine

  • 49

    red no.40

    allura red

  • 50

    yellow no.5

    tartrazine

  • 51

    yellow no.6

    sunset yellow

  • 52

    water insoluble dies that had been absorbed on hydrous oxide usually alumina, used as dry powders

    lakes

  • 53

    salty

    cinnamon; orange; cherry; butterscotch

  • 54

    bitter

    chocolate; cherry; raspberry; mint

  • 55

    sour

    raspberry; lemon; fruity

  • 56

    oily

    mint; lmeon; orange

  • 57

    unpleasantly sweet

    vanilla; fruity

  • 58

    sucrose

    1000x

  • 59

    saccharin

    500x

  • 60

    na saccharin

    300x

  • 61

    acesulfame K

    180-200x

  • 62

    na cyclamate

    30x

  • 63

    process in tabblet manufacturing

    dispensing-milling-mixing-granulation-tableting-coating

  • 64

    uses air with very high pressure

    fluid energy mill

  • 65

    all ingredients are loaded together , mixed and discharged as a single batch

    batch type mixer

  • 66

    for high volume products; materials travel from charging port to dischharge nozzle

    continuous mixer

  • 67

    fine granules

    pass through sieve no.40

  • 68

    good granules

    pass through seive no.20 but not 40

  • 69

    Heart of Production area • HEPA: 99.97% efficiency against 0.3 mcm or larger • QC test: DOP, Bubble point test, HC Emery 3004

    asceptc filling area

  • 70

    -most astringent control -class 100

    compounding area

  • 71

    -surfaces shoud be continuous -class 10,000

    materials support area

  • 72

    Hair should be covered • General protective suit

    GRADE D

  • 73

    • Hair should be covered • Single or two-piece suit gathered at the wrist and with high neck and appropriate shoes or overshoes should be worn • should shed virtually no fibers or particulate matter

    GRADE C

  • 74

    Background environment ofGradeA • Both Grade A and B should observe: o Headgear totally enclose hair o Face mask o Tucked trouser pants

    GRADE B

  • 75

    Local zone for high-risk operations • Filling zone, stopper, aseptic connections • Laminar air flow workstation with a HEPA • Compounding Area

    GRADE A

  • 76

    Components are combined by melting together (70-75C) and cooled with constant stirring until congealed • Equipment: Stem-jacketed Kettle

    FUSION

  • 77

    USES MOLD

    COMPRESSIO

  • 78

    MOLDING OF SUPPOSITORY BY USING FINGERS

    HAND ROLLING

  • 79

    Both cationic and anionic • Lecithin, Betaine

    AMPHOTERIC

  • 80

    Not affected by pH • Sorbitan esters/SPANS, Polysorbates/TWEENS

    NONIONIC

  • 81

    Positive, effective at acidic pH • Benzalkonium Cl, Cetylpyridinium Cl

    CATIONIC

  • 82

    Negative, effective at basic pH • SLS, soap, sarcosinates

    ANIONIC

  • 83

    Thickening agents and stabilizers for o/w emulsions of certain topical preparations • Ex.: Stearyl/cetyl ROH, glyceryl monostearate (O/W); Cholesterol derivatives (W/O)

    HIGH MOLECULAR WEIGHT ALCOHOLS

  • 84

    Form o/w emulsions when the insoluble material is added to the aq. Phase if there is a greater volume of the aqueous phase than of the oleaginous phase • Ex.: Bentonite magma, veegum

    finely divided powders

  • 85

    Finely divided solid drug is reacted with another substance, Ex.: Milk of Magnesia

    PRECIPITATION

  • 86

    Finely divided solid drug is wetted first before dispersion in the liquid vehicle

    DISPERSION

  • 87

    Decreases zeta potential of the suspended charged particles that cause aggregation.

    FLOCCULATING AGENTS

  • 88

    Agar, Gelatin, Pectin, Gelatinized starch

    OTHERS

  • 89

    Acacia, Tragacanth, Cellulose derivatives

    HYDROCOLLOIDS

  • 90

    Veegum, bentonite, kaolin

    CLAYS

  • 91

    Viscosity-increasing agents used to reduce sedimentation rate of particles in a vehicle

    SUSPENDING AGENTS

  • 92

    uses the container as the means for controlling the fill. Adjusted by height.

    CONSTANT-LEVEL

  • 93

    Positive displacement of piston action or by the pumping of a liquid at a constant pressure and gives constant volume

    VOLUMETRIC

  • 94

    Weighing according to weight • For large containers, highly viscous liquids, mobile and frothy solutions

    GRAVIMETRIC

  • 95

    Should be carefully monitored and allow constant mixing

    Filling and Packaging

  • 96

    Compresses liquid with high pressure by a strong spring mechanism for emulsification

    HOMOGENIZER

  • 97

    Comminution of solids and dispersions of suspension

    COLLOID MILL

  • 98

    Mixers with various impellers mounted on shafts, PROBLEM: Vortex formation

    MECHANICAL STIRRER

  • 99

    detachment of the film due to the entrapment of gas

    BLISTERING

  • 100

    cratter appear exposing the tabllet surface due to coating solution penetratiing parts of the surface where it is more porous

    CRATERING

    • gastro

    gastro

    Hannah Angelique Losaria · 100問 · 2年前

    gastro

    gastro

    100問 • 2年前
    Hannah Angelique Losaria

    gastro m

    gastro m

    Hannah Angelique Losaria · 7問 · 2年前

    gastro m

    gastro m

    7問 • 2年前
    Hannah Angelique Losaria

    lab

    lab

    Hannah Angelique Losaria · 13問 · 2年前

    lab

    lab

    13問 • 2年前
    Hannah Angelique Losaria

    m2

    m2

    Hannah Angelique Losaria · 94問 · 2年前

    m2

    m2

    94問 • 2年前
    Hannah Angelique Losaria

    m1

    m1

    Hannah Angelique Losaria · 88問 · 2年前

    m1

    m1

    88問 • 2年前
    Hannah Angelique Losaria

    poisons

    poisons

    Hannah Angelique Losaria · 50問 · 1年前

    poisons

    poisons

    50問 • 1年前
    Hannah Angelique Losaria

    lec

    lec

    Hannah Angelique Losaria · 19問 · 1年前

    lec

    lec

    19問 • 1年前
    Hannah Angelique Losaria

    exam

    exam

    Hannah Angelique Losaria · 16問 · 1年前

    exam

    exam

    16問 • 1年前
    Hannah Angelique Losaria

    spec

    spec

    Hannah Angelique Losaria · 41問 · 1年前

    spec

    spec

    41問 • 1年前
    Hannah Angelique Losaria

    midterm

    midterm

    Hannah Angelique Losaria · 55問 · 1年前

    midterm

    midterm

    55問 • 1年前
    Hannah Angelique Losaria

    PHYSICAL PHARMACY

    PHYSICAL PHARMACY

    Hannah Angelique Losaria · 54問 · 1年前

    PHYSICAL PHARMACY

    PHYSICAL PHARMACY

    54問 • 1年前
    Hannah Angelique Losaria

    PHYSICAL PHARMACY II

    PHYSICAL PHARMACY II

    Hannah Angelique Losaria · 29問 · 1年前

    PHYSICAL PHARMACY II

    PHYSICAL PHARMACY II

    29問 • 1年前
    Hannah Angelique Losaria

    DDS

    DDS

    Hannah Angelique Losaria · 33問 · 1年前

    DDS

    DDS

    33問 • 1年前
    Hannah Angelique Losaria

    hallucinogens

    hallucinogens

    Hannah Angelique Losaria · 22問 · 1年前

    hallucinogens

    hallucinogens

    22問 • 1年前
    Hannah Angelique Losaria

    non volatile poisons

    non volatile poisons

    Hannah Angelique Losaria · 42問 · 1年前

    non volatile poisons

    non volatile poisons

    42問 • 1年前
    Hannah Angelique Losaria

    endterm

    endterm

    Hannah Angelique Losaria · 63問 · 1年前

    endterm

    endterm

    63問 • 1年前
    Hannah Angelique Losaria

    q3 endterm

    q3 endterm

    Hannah Angelique Losaria · 17問 · 1年前

    q3 endterm

    q3 endterm

    17問 • 1年前
    Hannah Angelique Losaria

    mockboard 2019

    mockboard 2019

    Hannah Angelique Losaria · 65問 · 1年前

    mockboard 2019

    mockboard 2019

    65問 • 1年前
    Hannah Angelique Losaria

    mockboard 2019 II

    mockboard 2019 II

    Hannah Angelique Losaria · 39問 · 1年前

    mockboard 2019 II

    mockboard 2019 II

    39問 • 1年前
    Hannah Angelique Losaria

    問題一覧

  • 1

    large scale production of drug products' preparation, processing, packaging, labeling, repacking, chamging wrapper, label or container of any drug products

    manufacturing

  • 2

    manufacturing of APIs and exipients

    primary manfacturing

  • 3

    manufacture of finished dosage form

    seondary

  • 4

    packing, labeling, and repacking of bulk finished products

    tertiary

  • 5

    an arrangement whereby a competent company manufactures for another compnay

    toll

  • 6

    formulates new products; reformulates new products, does chemical, pharmaceutical and physiological research

    research and development department

  • 7

    manufactures products according to schedule; warehousing (inventory control) and storage

    production department

  • 8

    assures that all operations meet required standards for safety and efficacy; ensures compliance to cGMP; prepares SOPs

    QA department

  • 9

    test compliance of raw materials, packaging materials, and fnished products; conducts sampling of materials to be tested; performs IPQC and environmental testing

    QC department

  • 10

    specific quantity of products itended to have uniform character an dquality produced during a single manufacturing process

    batch

  • 11

    specific identified portion of a batch

    lot

  • 12

    for identification and traceability of a single batch

    batch number

  • 13

    contains formulation, manufacturing procedures, specifications, QA requirements, and labeling of finihsed products

    master formula

  • 14

    ensures that batches were properly made and qc tests were perormed; actual yield

    master bach record/ batch manufacturing record

  • 15

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

    SOP

  • 16

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

    overage

  • 17

    color of quarantined products

    yellow

  • 18

    color of approved products

    green

  • 19

    color of rejected products

    red

  • 20

    documented evidence that a system does what it is supposed to do

    validation

  • 21

    an economic way of protecting, preparing, identifing, an contaning prducts

    packaging

  • 22

    protects content from extraneous solids

    protects content from extraneous solids

  • 23

    protects content from extraneous solids, liqids, and vapors; protects from delinquescence, effflorescence, evaporation

    tight

  • 24

    impprevious to air or any other gas

    hermetic

  • 25

    type I glass: with boric acid; high resistance; for buffered and non buffered aqueous parenteral solution

    highly resistante borosilicate glass

  • 26

    type II glass surface is treated with SO2; dealkalized; for buffered acidic non aqueous solutions

    treated soda lme glass

  • 27

    type III glass low resistance; for reconstituted dry solids and non aqueous liquids

    soda llime glass

  • 28

    orgnic polymers of HMW

    plastic

  • 29

    type of plastic that is soft when heated and hard when cooled; flexible and squeezable

    thermoplastic

  • 30

    for beverages

    1. polyethylene terephthalate

  • 31

    hard thermoset for solid dosage froms

    2. high density polyethylene

  • 32

    for blister packs

    3. polyvinyl chloride

  • 33

    high temperature resistance

    5. polypropylene

  • 34

    display of written, printed, or graphic matter on immediate conatiner

    label

  • 35

    cold

    NMT 2-8

  • 36

    freezer

    -10 to -20

  • 37

    refrigerator

    2-8

  • 38

    cool

    8-15

  • 39

    controlled room temperature

    20-25

  • 40

    warm

    30-40

  • 41

    innert substance added to increase tablet size which is practical for compression

    diluent/filler

  • 42

    imparts cohesiveness to powders causing them to form granules

    binders

  • 43

    hydrophobic powders added prior to compression to reduce friction and improve flow properties

    antifrictions/flow activators

  • 44

    reduces sticking to punch faces or die walls

    anti adherent

  • 45

    blue no.1

    brilliant blue FCF

  • 46

    blue no.2

    indigoitne

  • 47

    green no.3

    fast green FCF

  • 48

    red no.3

    erythrosine

  • 49

    red no.40

    allura red

  • 50

    yellow no.5

    tartrazine

  • 51

    yellow no.6

    sunset yellow

  • 52

    water insoluble dies that had been absorbed on hydrous oxide usually alumina, used as dry powders

    lakes

  • 53

    salty

    cinnamon; orange; cherry; butterscotch

  • 54

    bitter

    chocolate; cherry; raspberry; mint

  • 55

    sour

    raspberry; lemon; fruity

  • 56

    oily

    mint; lmeon; orange

  • 57

    unpleasantly sweet

    vanilla; fruity

  • 58

    sucrose

    1000x

  • 59

    saccharin

    500x

  • 60

    na saccharin

    300x

  • 61

    acesulfame K

    180-200x

  • 62

    na cyclamate

    30x

  • 63

    process in tabblet manufacturing

    dispensing-milling-mixing-granulation-tableting-coating

  • 64

    uses air with very high pressure

    fluid energy mill

  • 65

    all ingredients are loaded together , mixed and discharged as a single batch

    batch type mixer

  • 66

    for high volume products; materials travel from charging port to dischharge nozzle

    continuous mixer

  • 67

    fine granules

    pass through sieve no.40

  • 68

    good granules

    pass through seive no.20 but not 40

  • 69

    Heart of Production area • HEPA: 99.97% efficiency against 0.3 mcm or larger • QC test: DOP, Bubble point test, HC Emery 3004

    asceptc filling area

  • 70

    -most astringent control -class 100

    compounding area

  • 71

    -surfaces shoud be continuous -class 10,000

    materials support area

  • 72

    Hair should be covered • General protective suit

    GRADE D

  • 73

    • Hair should be covered • Single or two-piece suit gathered at the wrist and with high neck and appropriate shoes or overshoes should be worn • should shed virtually no fibers or particulate matter

    GRADE C

  • 74

    Background environment ofGradeA • Both Grade A and B should observe: o Headgear totally enclose hair o Face mask o Tucked trouser pants

    GRADE B

  • 75

    Local zone for high-risk operations • Filling zone, stopper, aseptic connections • Laminar air flow workstation with a HEPA • Compounding Area

    GRADE A

  • 76

    Components are combined by melting together (70-75C) and cooled with constant stirring until congealed • Equipment: Stem-jacketed Kettle

    FUSION

  • 77

    USES MOLD

    COMPRESSIO

  • 78

    MOLDING OF SUPPOSITORY BY USING FINGERS

    HAND ROLLING

  • 79

    Both cationic and anionic • Lecithin, Betaine

    AMPHOTERIC

  • 80

    Not affected by pH • Sorbitan esters/SPANS, Polysorbates/TWEENS

    NONIONIC

  • 81

    Positive, effective at acidic pH • Benzalkonium Cl, Cetylpyridinium Cl

    CATIONIC

  • 82

    Negative, effective at basic pH • SLS, soap, sarcosinates

    ANIONIC

  • 83

    Thickening agents and stabilizers for o/w emulsions of certain topical preparations • Ex.: Stearyl/cetyl ROH, glyceryl monostearate (O/W); Cholesterol derivatives (W/O)

    HIGH MOLECULAR WEIGHT ALCOHOLS

  • 84

    Form o/w emulsions when the insoluble material is added to the aq. Phase if there is a greater volume of the aqueous phase than of the oleaginous phase • Ex.: Bentonite magma, veegum

    finely divided powders

  • 85

    Finely divided solid drug is reacted with another substance, Ex.: Milk of Magnesia

    PRECIPITATION

  • 86

    Finely divided solid drug is wetted first before dispersion in the liquid vehicle

    DISPERSION

  • 87

    Decreases zeta potential of the suspended charged particles that cause aggregation.

    FLOCCULATING AGENTS

  • 88

    Agar, Gelatin, Pectin, Gelatinized starch

    OTHERS

  • 89

    Acacia, Tragacanth, Cellulose derivatives

    HYDROCOLLOIDS

  • 90

    Veegum, bentonite, kaolin

    CLAYS

  • 91

    Viscosity-increasing agents used to reduce sedimentation rate of particles in a vehicle

    SUSPENDING AGENTS

  • 92

    uses the container as the means for controlling the fill. Adjusted by height.

    CONSTANT-LEVEL

  • 93

    Positive displacement of piston action or by the pumping of a liquid at a constant pressure and gives constant volume

    VOLUMETRIC

  • 94

    Weighing according to weight • For large containers, highly viscous liquids, mobile and frothy solutions

    GRAVIMETRIC

  • 95

    Should be carefully monitored and allow constant mixing

    Filling and Packaging

  • 96

    Compresses liquid with high pressure by a strong spring mechanism for emulsification

    HOMOGENIZER

  • 97

    Comminution of solids and dispersions of suspension

    COLLOID MILL

  • 98

    Mixers with various impellers mounted on shafts, PROBLEM: Vortex formation

    MECHANICAL STIRRER

  • 99

    detachment of the film due to the entrapment of gas

    BLISTERING

  • 100

    cratter appear exposing the tabllet surface due to coating solution penetratiing parts of the surface where it is more porous

    CRATERING