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83問 • 1年前
  • Hannah Angelique Losaria
    • 通報

    問題一覧

  • 1

    totality features or conformance to specifications of a product

    quality

  • 2

    quality is everybody's business

    total quality management

  • 3

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

    cGMP

  • 4

    regular periodic quality reviews of al registered drug products to verify consistency of the existing process and to ientify product and process improvements

    product quality review

  • 5

    a systematic process for the assessment, control, comunication, 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 tests -inspects raw materials, in process products, finished products

    quality control

  • 9

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

    quality assurance

  • 10

    udesired characteristic of a raw material or product which indicates that it failed to conform to rhe standards

    defect

  • 11

    removal of the product from themarket because it is either defective or harmful

    product recall

  • 12

    glucagon, atropine

    cat

  • 13

    oxytocin

    chicken

  • 14

    PTH

    dog

  • 15

    digitalis

    pigeon

  • 16

    cod liver oil chorionic gonadotropin corticotropin vasopressin

    rats

  • 17

    heparin, protamin sulfate

    sheep

  • 18

    insulin, tobocurarine

    rabbit

  • 19

    lacrobacillus plantarum

    niacin b3, pantothenic acid b5

  • 20

    lactobacillus leichmannii

    cobalamin b12

  • 21

    micrococcus luteus

    bacitracin

  • 22

    e. coli

    chloramphenicol

  • 23

    s. aureus

    pen g

  • 24

    k. pneumoniae

    streptomycin

  • 25

    b. subtilis med

    vancomycin

  • 26

    hydrogen sulfide ts

    heavy metals

  • 27

    silver diethyldithiocarbamate ts

    arsenic

  • 28

    ammonium thiocanite ts

    iron

  • 29

    silver nitrate ts

    chloride

  • 30

    barium chloride ts

    sulfate

  • 31

    -fastest -used at least 25g of sample

    seive analysis

  • 32

    measure of flowability -maximum angle potential between the surface of the pile of the powder and the horizontal plane

    angle of repose

  • 33

    measure of compressibility

    carr's compressibility index

  • 34

    measure of flowability

    hausner's ratio

  • 35

    measure dissolution, disintegration, and bioavailability

    hardness

  • 36

    4-10 kg

    coated tablet

  • 37

    2-3 kg

    sl, chewable

  • 38

    7/8-10kg

    buccal

  • 39

    >10kg

    mr tablet

  • 40

    crude method/ sharp snap

    rule of thumb

  • 41

    spring

    stokes monsanto

  • 42

    air pump// hydraulic pressure

    strong cobb

  • 43

    pliers llike

    pfizer

  • 44

    suspended motor driven weight

    erweka

  • 45

    motor-driven anvil cushes tablet horizontally

    schleuniger/ heberlein

  • 46

    -identical appearance -faciliitate packaging -accuray for tablet counting machines

    thickness

  • 47

    uncoated/ir tablet in water

    30mins

  • 48

    capsule in water

    2-3 mins

  • 49

    sl tablet in water

    2 mins

  • 50

    buccal tablets in water

    4 hrs

  • 51

    ECT in water

    5 mins

  • 52

    ETC in stimulated gastric fluid

    1 hr, no sign

  • 53

    ETC in stimulated intestinal fluid

    immediately

  • 54

    • Test for measuring the amount of time required for a given % of drug substance in a tablet to go into solution • Equipment: Vessel with cover, water bath maintained at 37±0.5 °C metallic drive shaft or Paddle.

    dissolution

  • 55

    1

    basket

  • 56

    2

    paddle

  • 57

    3

    reciprocating cylinder

  • 58

    4

    flow through cell

  • 59

    5

    paddle over disk

  • 60

    6

    revolving cylinder

  • 61

    7

    reciprocating holder

  • 62

    o ≥ 25mg API per dose and comprising ≥ 25% by wt. of dosage unit o Sample: 20 uncoated compressed tablets

    weight variation

  • 63

    o Ensures formulation potency o <25 mg API per dose and comprising <25% by wt. of dosage unit o Sample: 10 units (assay individually); 20 units on retest o Acceptance Criteria: 85-115% API (100±15)

    content uniformity

  • 64

    microbial content for opthalmic

    sterile

  • 65

    mirobial content for topica dosage forms

    no p. auruginosa, s. aureus

  • 66

    microbal content for urethral, vaginal

    no molds and yeast

  • 67

    • For semisolids with labeled content of NMT 150g or 150ml • Sample: 10 containers (assay individually); 20 containers on retest 𝑛𝑒𝑡 𝑐𝑜𝑛𝑡𝑒𝑛𝑡 = 𝑖𝑛𝑖𝑡𝑖𝑎𝑙 𝑤𝑒𝑖𝑔ℎ𝑡 − 𝑓𝑖𝑛𝑎𝑙 𝑤𝑒𝑖𝑔ℎ𝑡 • Initial wt.: container with sample (unlabeled, cleansed, then dried) • Final wt.: empty container (heated at 100°C for 5 mins then cooled) • Acceptance Criteria: o Aerosols ▪ <60 g or 60 ml: >90% ▪ ≥ 60 g or 60 ml: > 95% o Non-aerosols ▪ Net content > labeled content

    minimum full

  • 68

    • Applicable for liquid products NMT 250mL • Sample size: 10 containers; 20 containers on retest • Procedure: (Angle: 30°; prevent air-bubble formation) • Single unit: drain in 5 seconds • Multiple unit: drain in ≤30 mins

    deliverable volume

  • 69

    ideal: 100% with minimum agitation

    redispersibility

  • 70

    measure of resistance to flow -should not be too fluid nor too viscous

    viscosity

  • 71

    reulsive forces between particles

    zeta potential

  • 72

    dye solubility in o/w

    amaranth green, methyl red

  • 73

    dye solubility in w/o

    sudan red

  • 74

    uv flourencence in w/o

    yes

  • 75

    uv flourencence in o/w

    no

  • 76

    conductivity in w/o

    no

  • 77

    conductivity in o/w

    yes

  • 78

    cobalt chloride in w/o

    blue

  • 79

    cobalt chloride in o/w

    pink

  • 80

    b. stearothermophilus

    steam/ moist heat

  • 81

    b. subtilis

    dry heat

  • 82

    b. pumillus

    ionizing radiation

  • 83

    p. diminuta

    sterilizing membrane filter

    • 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 conformance to specifications of a product

    quality

  • 2

    quality is everybody's business

    total quality management

  • 3

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

    cGMP

  • 4

    regular periodic quality reviews of al registered drug products to verify consistency of the existing process and to ientify product and process improvements

    product quality review

  • 5

    a systematic process for the assessment, control, comunication, 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 tests -inspects raw materials, in process products, finished products

    quality control

  • 9

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

    quality assurance

  • 10

    udesired characteristic of a raw material or product which indicates that it failed to conform to rhe standards

    defect

  • 11

    removal of the product from themarket because it is either defective or harmful

    product recall

  • 12

    glucagon, atropine

    cat

  • 13

    oxytocin

    chicken

  • 14

    PTH

    dog

  • 15

    digitalis

    pigeon

  • 16

    cod liver oil chorionic gonadotropin corticotropin vasopressin

    rats

  • 17

    heparin, protamin sulfate

    sheep

  • 18

    insulin, tobocurarine

    rabbit

  • 19

    lacrobacillus plantarum

    niacin b3, pantothenic acid b5

  • 20

    lactobacillus leichmannii

    cobalamin b12

  • 21

    micrococcus luteus

    bacitracin

  • 22

    e. coli

    chloramphenicol

  • 23

    s. aureus

    pen g

  • 24

    k. pneumoniae

    streptomycin

  • 25

    b. subtilis med

    vancomycin

  • 26

    hydrogen sulfide ts

    heavy metals

  • 27

    silver diethyldithiocarbamate ts

    arsenic

  • 28

    ammonium thiocanite ts

    iron

  • 29

    silver nitrate ts

    chloride

  • 30

    barium chloride ts

    sulfate

  • 31

    -fastest -used at least 25g of sample

    seive analysis

  • 32

    measure of flowability -maximum angle potential between the surface of the pile of the powder and the horizontal plane

    angle of repose

  • 33

    measure of compressibility

    carr's compressibility index

  • 34

    measure of flowability

    hausner's ratio

  • 35

    measure dissolution, disintegration, and bioavailability

    hardness

  • 36

    4-10 kg

    coated tablet

  • 37

    2-3 kg

    sl, chewable

  • 38

    7/8-10kg

    buccal

  • 39

    >10kg

    mr tablet

  • 40

    crude method/ sharp snap

    rule of thumb

  • 41

    spring

    stokes monsanto

  • 42

    air pump// hydraulic pressure

    strong cobb

  • 43

    pliers llike

    pfizer

  • 44

    suspended motor driven weight

    erweka

  • 45

    motor-driven anvil cushes tablet horizontally

    schleuniger/ heberlein

  • 46

    -identical appearance -faciliitate packaging -accuray for tablet counting machines

    thickness

  • 47

    uncoated/ir tablet in water

    30mins

  • 48

    capsule in water

    2-3 mins

  • 49

    sl tablet in water

    2 mins

  • 50

    buccal tablets in water

    4 hrs

  • 51

    ECT in water

    5 mins

  • 52

    ETC in stimulated gastric fluid

    1 hr, no sign

  • 53

    ETC in stimulated intestinal fluid

    immediately

  • 54

    • Test for measuring the amount of time required for a given % of drug substance in a tablet to go into solution • Equipment: Vessel with cover, water bath maintained at 37±0.5 °C metallic drive shaft or Paddle.

    dissolution

  • 55

    1

    basket

  • 56

    2

    paddle

  • 57

    3

    reciprocating cylinder

  • 58

    4

    flow through cell

  • 59

    5

    paddle over disk

  • 60

    6

    revolving cylinder

  • 61

    7

    reciprocating holder

  • 62

    o ≥ 25mg API per dose and comprising ≥ 25% by wt. of dosage unit o Sample: 20 uncoated compressed tablets

    weight variation

  • 63

    o Ensures formulation potency o <25 mg API per dose and comprising <25% by wt. of dosage unit o Sample: 10 units (assay individually); 20 units on retest o Acceptance Criteria: 85-115% API (100±15)

    content uniformity

  • 64

    microbial content for opthalmic

    sterile

  • 65

    mirobial content for topica dosage forms

    no p. auruginosa, s. aureus

  • 66

    microbal content for urethral, vaginal

    no molds and yeast

  • 67

    • For semisolids with labeled content of NMT 150g or 150ml • Sample: 10 containers (assay individually); 20 containers on retest 𝑛𝑒𝑡 𝑐𝑜𝑛𝑡𝑒𝑛𝑡 = 𝑖𝑛𝑖𝑡𝑖𝑎𝑙 𝑤𝑒𝑖𝑔ℎ𝑡 − 𝑓𝑖𝑛𝑎𝑙 𝑤𝑒𝑖𝑔ℎ𝑡 • Initial wt.: container with sample (unlabeled, cleansed, then dried) • Final wt.: empty container (heated at 100°C for 5 mins then cooled) • Acceptance Criteria: o Aerosols ▪ <60 g or 60 ml: >90% ▪ ≥ 60 g or 60 ml: > 95% o Non-aerosols ▪ Net content > labeled content

    minimum full

  • 68

    • Applicable for liquid products NMT 250mL • Sample size: 10 containers; 20 containers on retest • Procedure: (Angle: 30°; prevent air-bubble formation) • Single unit: drain in 5 seconds • Multiple unit: drain in ≤30 mins

    deliverable volume

  • 69

    ideal: 100% with minimum agitation

    redispersibility

  • 70

    measure of resistance to flow -should not be too fluid nor too viscous

    viscosity

  • 71

    reulsive forces between particles

    zeta potential

  • 72

    dye solubility in o/w

    amaranth green, methyl red

  • 73

    dye solubility in w/o

    sudan red

  • 74

    uv flourencence in w/o

    yes

  • 75

    uv flourencence in o/w

    no

  • 76

    conductivity in w/o

    no

  • 77

    conductivity in o/w

    yes

  • 78

    cobalt chloride in w/o

    blue

  • 79

    cobalt chloride in o/w

    pink

  • 80

    b. stearothermophilus

    steam/ moist heat

  • 81

    b. subtilis

    dry heat

  • 82

    b. pumillus

    ionizing radiation

  • 83

    p. diminuta

    sterilizing membrane filter