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67問 • 1年前
  • Hannah Angelique Losaria
    • 通報

    問題一覧

  • 1

    totality features or conformmance to specifications of a product

    quality

  • 2

    quality is everybody's business

    total quality management

  • 3

    part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate for their intended use

    cGMP

  • 4

    regular periodic quality reviews of all registereddrug products to verify consistency of the existing process and to identify product and process improvements

    product quality review

  • 5

    a systematic process for the assessment, control, communication, and review of risks to the quality of the product

    quality risk management

  • 6

    selecting appropriate number from the population

    sampling

  • 7

    contains the detailed requirements and must be confirmed

    specification

  • 8

    -conducts the required test -inspects raw materials, in-process produtcs, fiinished products

    quality control

  • 9

    -audit and monitoring -ensures policies are followed -cooperates with regulatory agencies -prepares SOP

    qquality assurance

  • 10

    undesirable characteristics of a raw material or product which indicates that it failed t conform to the standard

    defect

  • 11

    defect is visible

    occular

  • 12

    defect is not visible

    internaal

  • 13

    funtional defect

    performance

  • 14

    directly measured by instruments; height, eight, concentration, thickness, volume

    variable

  • 15

    cannot b directly measured; color, density

    attribute

  • 16

    no harm to consumer, no problem in function

    minnor

  • 17

    no harm to consumer, product is useless

    major

  • 18

    harms consumer, product is useless

    critical

  • 19

    removal of the product from the market because it is either defective of harmful

    product recall

  • 20

    may cause death o serious adverse health consequences

    class 1

  • 21

    ma cause temporary/ medically eversible adverse health consequences

    class 2

  • 22

    not likely to cause adverse health consequences

    class 3

  • 23

    -extent to which a product remains stable and within specifications -retains original characterisics nlt 90%

    stability

  • 24

    period of time during which a product is expected to remain within specification

    shelf life

  • 25

    date beyond which product loses stability and after whic it mus not be used

    expiration date

  • 26

    -conducte under normal conditions -testing period: 0,3,6,9,12,15,18,24,3

    long term

  • 27

    -designed to increase the rate of chemical degradationby using exagerrated storage conditions -testing period:0,3,6

    accelerated

  • 28

    -elucidates the intrinsic stability of the drug substance and identify the likely degradation products -ccarried out uner more severe conditions

    stress testing

  • 29

    glucagon, atropine

    cat

  • 30

    oxytocin

    chicken

  • 31

    PTH

    dog

  • 32

    digitalis

    [igeon

  • 33

    cod liver oil chorionic gonadotropin corticotropin vasopressin

    rats

  • 34

    heparin, protamin sulfate

    sheep

  • 35

    insulin, tobocurarine

    rabbit

  • 36

    systemic injection test -parenteral containers

    albino mice

  • 37

    intracutaneous tets -parenteral containers

    albino rabbits

  • 38

    eye irritation test -opthalmic cntainers

    albino rabbits

  • 39

    implantation test -material in direct contact with tissues

    rabbits

  • 40

    heavy metals

    hydrogen sulfide ts

  • 41

    arsenic

    silver diethyldithiocarbamate ts

  • 42

    iron

    ammonium thiocyanate ts

  • 43

    chloride

    silver nitrate ts

  • 44

    sulfate

    barium chloride ts

  • 45

    2 tangents seprated by the longest distance

    feret

  • 46

    distance thatwill bisent the particles

    martin

  • 47

    -diameter of the circle that will enclose the particles -same as field microscope

    projected areaof the circle

  • 48

    sieve #

    the square openings in every linear inch of the seive

  • 49

    retained by #20 seive

    coarse

  • 50

    passes #20 but not #40 seive

    good

  • 51

    pases #40 seive

    fine

  • 52

    method 1 of bulk density

    graduated cylinder

  • 53

    method 2 of bulk density

    scott vilumeter

  • 54

    method 3 of bulk density

    vessel

  • 55

    method 1 of tapped density

    graduated cyliner

  • 56

    mmethod 2 of tapped density

    graduated cyliinder

  • 57

    method 3 of tapped density

    vessel

  • 58

    -measure of flowability -maximum angle possible between the surface of the pile of powder nd he horiizontal plane

    angle of repose

  • 59

    measure of compressibility

    carr's compressibility index

  • 60

    measure of flowability

    hausner's ratio

  • 61

    measure of dissolution, disintegration, and bioavailablity

    hardness

  • 62

    crude method/ sharp snap (acceptable)

    rule oof thumb

  • 63

    spring

    stokes (monsanto)

  • 64

    air pump/ hydraulic pressure

    strong cobb

  • 65

    pliers (like)

    pfizer

  • 66

    suspended motor-driven weight

    erweka

  • 67

    motor driven anvil crushes tablet horizontally; most widely use (eliminates operator vaiability)

    schleuniger/ heberlein

    • 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

    totality features or conformmance to specifications of a product

    quality

  • 2

    quality is everybody's business

    total quality management

  • 3

    part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate for their intended use

    cGMP

  • 4

    regular periodic quality reviews of all registereddrug products to verify consistency of the existing process and to identify product and process improvements

    product quality review

  • 5

    a systematic process for the assessment, control, communication, and review of risks to the quality of the product

    quality risk management

  • 6

    selecting appropriate number from the population

    sampling

  • 7

    contains the detailed requirements and must be confirmed

    specification

  • 8

    -conducts the required test -inspects raw materials, in-process produtcs, fiinished products

    quality control

  • 9

    -audit and monitoring -ensures policies are followed -cooperates with regulatory agencies -prepares SOP

    qquality assurance

  • 10

    undesirable characteristics of a raw material or product which indicates that it failed t conform to the standard

    defect

  • 11

    defect is visible

    occular

  • 12

    defect is not visible

    internaal

  • 13

    funtional defect

    performance

  • 14

    directly measured by instruments; height, eight, concentration, thickness, volume

    variable

  • 15

    cannot b directly measured; color, density

    attribute

  • 16

    no harm to consumer, no problem in function

    minnor

  • 17

    no harm to consumer, product is useless

    major

  • 18

    harms consumer, product is useless

    critical

  • 19

    removal of the product from the market because it is either defective of harmful

    product recall

  • 20

    may cause death o serious adverse health consequences

    class 1

  • 21

    ma cause temporary/ medically eversible adverse health consequences

    class 2

  • 22

    not likely to cause adverse health consequences

    class 3

  • 23

    -extent to which a product remains stable and within specifications -retains original characterisics nlt 90%

    stability

  • 24

    period of time during which a product is expected to remain within specification

    shelf life

  • 25

    date beyond which product loses stability and after whic it mus not be used

    expiration date

  • 26

    -conducte under normal conditions -testing period: 0,3,6,9,12,15,18,24,3

    long term

  • 27

    -designed to increase the rate of chemical degradationby using exagerrated storage conditions -testing period:0,3,6

    accelerated

  • 28

    -elucidates the intrinsic stability of the drug substance and identify the likely degradation products -ccarried out uner more severe conditions

    stress testing

  • 29

    glucagon, atropine

    cat

  • 30

    oxytocin

    chicken

  • 31

    PTH

    dog

  • 32

    digitalis

    [igeon

  • 33

    cod liver oil chorionic gonadotropin corticotropin vasopressin

    rats

  • 34

    heparin, protamin sulfate

    sheep

  • 35

    insulin, tobocurarine

    rabbit

  • 36

    systemic injection test -parenteral containers

    albino mice

  • 37

    intracutaneous tets -parenteral containers

    albino rabbits

  • 38

    eye irritation test -opthalmic cntainers

    albino rabbits

  • 39

    implantation test -material in direct contact with tissues

    rabbits

  • 40

    heavy metals

    hydrogen sulfide ts

  • 41

    arsenic

    silver diethyldithiocarbamate ts

  • 42

    iron

    ammonium thiocyanate ts

  • 43

    chloride

    silver nitrate ts

  • 44

    sulfate

    barium chloride ts

  • 45

    2 tangents seprated by the longest distance

    feret

  • 46

    distance thatwill bisent the particles

    martin

  • 47

    -diameter of the circle that will enclose the particles -same as field microscope

    projected areaof the circle

  • 48

    sieve #

    the square openings in every linear inch of the seive

  • 49

    retained by #20 seive

    coarse

  • 50

    passes #20 but not #40 seive

    good

  • 51

    pases #40 seive

    fine

  • 52

    method 1 of bulk density

    graduated cylinder

  • 53

    method 2 of bulk density

    scott vilumeter

  • 54

    method 3 of bulk density

    vessel

  • 55

    method 1 of tapped density

    graduated cyliner

  • 56

    mmethod 2 of tapped density

    graduated cyliinder

  • 57

    method 3 of tapped density

    vessel

  • 58

    -measure of flowability -maximum angle possible between the surface of the pile of powder nd he horiizontal plane

    angle of repose

  • 59

    measure of compressibility

    carr's compressibility index

  • 60

    measure of flowability

    hausner's ratio

  • 61

    measure of dissolution, disintegration, and bioavailablity

    hardness

  • 62

    crude method/ sharp snap (acceptable)

    rule oof thumb

  • 63

    spring

    stokes (monsanto)

  • 64

    air pump/ hydraulic pressure

    strong cobb

  • 65

    pliers (like)

    pfizer

  • 66

    suspended motor-driven weight

    erweka

  • 67

    motor driven anvil crushes tablet horizontally; most widely use (eliminates operator vaiability)

    schleuniger/ heberlein