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Detect and quality variation.
  • Quinn Karylle Fuentes

  • 問題数 56 • 2/13/2024

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    問題一覧

  • 1

    Quality and characteristics are interpreted by descriptive word and measurements

    Specifications standard.

  • 2

    Subject variation.

    Specifications and standard

  • 3

    Not confine specific range and uncontrollably magnitude also proliferation error.

    quality variation.

  • 4

    Drug reference standard

    Specifications and standard.

  • 5

    Provides calibration level on biological effect against preparation can be compared.

    Reference standard.

  • 6

    Ingredients that comprise the product.

    Formula.

  • 7

    Characteristics range of urity of each ingredients.

    Raw material specifications.

  • 8

    Standard compedial like USP, NF AND BO

    Raw material specifications.

  • 9

    Step to step procedure how to go about the job.

    Standard operating procedure.

  • 10

    Spell imfo and. instructions from day-day to week-week.

    Standard operating procedure.

  • 11

    Cover all characteristics that affect proper performance depending on the nature situation.

    Finish products specifications.

  • 12

    Safety, purity. stability and tolerance.

    Finish products specifications.

  • 13

    Set everything that goes to the products Eg. Bottles, can, aluminum foil

    Packaging material standard.

  • 14

    Yield results of comparable precision and accuracy in the hand of diff operator and laboratories.

    Testing method.

  • 15

    Pharmacon means?

    Drug.

  • 16

    Poiein means?

    Make

  • 17

    A recipe or formula required to make or prepare standard

    Pharmacopeia.

  • 18

    Used by military hospital of army in year 1778 Pennsylvania.

    Lititz pharmacopeia.

  • 19

    A physician and created the national pharmacopeia and labeled as father of US Pharmacopeia.

    Dr. Lyman Spalding.

  • 20

    When was the first USP convention in Washington D.C

    January 1 1820.

  • 21

    When was the First USP published into latin nd English.

    December 15 1820.

  • 22

    Book for public pharmacopeia standard and contain standard medicine.

    USP/NF.

  • 23

    More on API

    USP.

  • 24

    More on excipient or inactive

    NF.

  • 25

    Dietary supplement and ingredients appear in separate section of USP.

    Monographs.

  • 26

    Sterility test.

    71

  • 27

    Bacterial endotoxin test.

    85.

  • 28

    Residue on ignition

    281

  • 29

    Bulk density and tapped density

    616

  • 30

    Chromatography

    621

  • 31

    Disintegrations

    701.

  • 32

    Dissolution

    711.

  • 33

    Particles size distribution

    786

  • 34

    Particulate contamination.

    708.

  • 35

    Powder finess

    811.

  • 36

    Uniformity dosage

    905.

  • 37

    Powder flow

    1174

  • 38

    Tablet friability

    1216.

  • 39

    Undesirable characteristics of product and failure to conform specifications.

    Defect.

  • 40

    Failure of entire products.

    Defective.

  • 41

    Measure directly by instrument.

    variable defect.

  • 42

    Cannot be measured by instrument judge only by odor and visual examination Eg: Color, clarity cleanliness and smoothness.

    attributes defect.

  • 43

    Endanger the life or may render products non functional

    Critical defect.

  • 44

    May affect the function and render products useless.

    Major defect.

  • 45

    Does not endanger a life and defect outside the prescribed unit.

    Minor defect.

  • 46

    Visible defect

    Ocular defect.

  • 47

    Defect cannot be seen even its present.

    internal defect

  • 48

    Defect function.

    Performance defect.

  • 49

    Method of withdrawing or correcting unsafe health products.

    Recall

  • 50

    Protect public and well being

    Recall.

  • 51

    Appropriate and good practice

    Recall.

  • 52

    Compliance with exist standard regulations.

    Recall.

  • 53

    will cause adverse health consequences or death.

    Class 1.

  • 54

    cause. temporary or medically reversible

    Class ll.

  • 55

    Not likely to cause. adverse health consequences.

    Class lll.

  • 56

    Tablet color, production pocket, pattrr color, brand seal and water mark

    Authenticity check.