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Manuf > (Lab) Act 1-5 > Flashcards

(Lab) Act 1-5 Flashcards

1
Q

cGMP stands for

A

Current Good Manufacturing Practice

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2
Q

ensures that medicines are made correctly and safely so that they work as they should and are safe to use.

A

cGMP

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3
Q

CGMP rules are made by a government agency called the

A

FDA

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4
Q

T/F: Production manager and QC manager should only be PRC registered pharmacis

A

False. Can be any other related profession (chemist, chemical engineer, etc

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5
Q

T/F: Production Manager and Quality Control Manager should be two different persons to avoid bias.

A

True

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6
Q

T/F; What is not written is not done.

A

True

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7
Q

T/F: Production Area should have a sufficient space to minimize clutter and allow smooth flow of
traffic

A

True

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8
Q

a process which provides a high degree of confidence or assurance that the said line or area is free from any unwanted residue or left over of previous processing’s before proceeding for next process.

A

Line clearance

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9
Q

LABELING REQUIREMENTS A.O

A

AO 55 s 1988

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10
Q

Prescribed rules and regulation for the packaging and labelling of food, drugs, devices and cosmetics distributed in the Philippines

A

Food, Drugs, Device and Cosmetics Art (RA 3720)

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11
Q

Generics Act of 1988

A

(RA 6675)

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12
Q

classification of drug

A

Pharmacologic/Pharmaceutical Category

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13
Q

clinical use; use based on what was submitted to FDA

A

Indication

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14
Q

GENERIC LABELLING REQUIREMENTS AND BRAND NAME CLEARANCE memorandum

A

Memorandum Circular No. 16-A s. 1994

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15
Q

Guidelines to be observed by FDA in clearance of name relative to food, drugs and cosmetics

A

Bureau Circular No. 21 s. 1999

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16
Q

Requirements for labeling materials of pharmaceutical products

A

A.O. No. 55 s. 1988

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17
Q

Requirements for labeling materials of certain categories of certain categories of products containing 2 or more active ingredients

A

A.O. No. 85 s. 1990

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18
Q

Requirements for labeling materials of categories of pharmaceutical products containing 4 or more active ingredients outside the coverage of A.O. no. 85 s. 1990

A

A.O. No. 99 s. 1990

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19
Q

Revised rules and regulations governing the generic labeling requirements of drug products for human use

A

A.O. no. 2016-0008

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20
Q

T/F: The unit content of each vitamin, mineral and/or herbal ingredient present shall no longer be required to be indicated in the generic box, but rather shall be reflected under FORMULATON

A

True

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21
Q

T/F: For multivitamin products with non-vitamin components, or multi-mineral products with non-mineral components; the term “Multivitamin” or “Mineral” or “Herbs”, respectively, shall first stated, followed by the generic name of the specific additional individual components

A

True

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22
Q

ALCOA stands for

A

Attributable, Legible, Contemporaneous, Original, and Accurate.

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23
Q

Additional Alcoa Principles (+)

A

Consistent
Complete
Enduring
Available

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24
Q

Identify the principle: Initials

A

Attributable

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25
Q

Identify the principle: Full handwritten signatures (with date and/or time, when applicable/required)

A

Attributable

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26
Q

Identify the principle: Personal seal

A

Attributable

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27
Q

Identify the principle: written clearly and readable by both
the writer and the reader

A

Legible

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28
Q

Identify the principle: prohibition of correction fluid/correction tape

A

Legible

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29
Q

Identify the principle: data superimposition

A

Legible

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30
Q

Identify the principle: Use of permanent, indelible ink

A

Legible

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31
Q

Identify the principle: Strict prohibition of use of pencil

A

Legible

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32
Q

Identify the principle: Strict prohibition of use of erasable pens

A

Legible

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33
Q

Identify the principle: “same time”, two actions happening at the
same time

A

Contemporaneous

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34
Q

Identify the principle: undocumented action is an action that did not happen

A

Contemporaneous

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35
Q

Identify the principle: Date and time of the action should be indicated when required

A

Contemporaneous

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36
Q

Identify the principle: NO back-dating (“ante-dating”)

A

Contemporaneous

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37
Q

Identify the principle:NO forward-dating (“advance dating”)

A

Contemporaneous

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38
Q

Identify the principle: all data required must be captured and explicitly recorded (brackets/braces/ditto marks (“) are not allowed to imply repetitive/same data. Use of N/A if field is not applicable.)

A

Complete

39
Q

Identify the principle: data are presented, recorded, dated, in defined sequence (date/time stamps)

A

Consistent

40
Q

Identify the principle: data and records must be sustained throughout their retention period

A

Enduring

41
Q

Identify the principle: data must be available anytime it is requested to be reviewed during inspection/regulatory audit

A

Available

42
Q

T/F: bioequivalence issues are minimally observed in liquid manufacturing

A

True (except for suspension)

43
Q

T/F: For syrups, elixirs or solutions in which nothing is suspended, the particle size and physical characteristics of the raw material are not that significant but these can still affect the rate of dissolution during the manufacturing process.

A

True

44
Q

Examples of heterogenous system

A

suspension, magmas, emulsion, lotions and gels

45
Q

Most common solvent used

A

Purified Water, USP

46
Q

pH of Purified Water, USP must be at

A

pH 5-7

47
Q

commonly used % of alcohol

A

95% ethanol

48
Q

Primary solvent for organic compounds

A

Alcohol, USP

49
Q

At certain concentrations, what % of alcohol is self preserving

A

10-12%

50
Q

% sufficient alcohol to maintain the drug in the
solution

A

5-40%

51
Q

Clear, syrupy liquid with a sweet taste

A

Glycerin

52
Q

Used as stabilizer and co solvent

A

Glycerin

53
Q

Substitute to glycerin

A

Propylene Glycol

54
Q

Common used preservatives:

A

Benzoic acid, Sodium Benzoate, Parabens

55
Q

T/F: Propylparaben and methylparaben can be used alone or in
combination

A
56
Q

In what ratio do propylparaben and methylparaben produce a synergistic effect that gives a higher total preservative concentration or action

A

1:10

57
Q

employ something that has a stronger flavor to mask the unpleasant taste

A

Masking/Overshadowing

58
Q

a barrier is utilized in order to reduce the contact of the drug with receptors present in taste buds

A

Physical Method

59
Q

involves chemical reaction to mask the taste

A

Chemical method

60
Q

using ingredients that either compete with the drug for the receptor site or by desensitizing taste buds

A

Physiological method

61
Q

Clear, sweetened hydroalcoholic solution intended for oral use and are usually flavored to enhance their palatability

A

Elixirs

62
Q

Sugar + alcohol

A

Elixirs

63
Q

T/F: Elixirs are prepared by simple solution with agitation and/or by the admixture of two or more liquid ingredients.

A

True

64
Q

T/F: elixirs are less effective in masking
the taste of medicinal substances or APIs because they are less sweet and less viscous

A

True

65
Q

Used to treat coughs and congestions usually caused by common
colds

A

Guaifenesin Oral Solution or Elixir

66
Q

Guaifenesin Oral Solution or Elixir Acts by _____________ the mucus in the airways and making coughs
_____________

A

loosening; more productive

67
Q

T/F: Turbidity in making elixirs is a wanted outcome.

A

False

68
Q

What to do when Elixir turns turbid?

A

Add filtering aid , Stir, Stand overnight

69
Q

T/F: The alcohol content when present in a pharmaceutical product must be expressed in % alcohol strength in the formulation.

A

True

70
Q

Standard concentration of alcohol used:

A

95%

71
Q

critical role in the control of microbial
growth

A

Sucrose concentration

72
Q

T/F: Diluted sucrose solution = prone to microbial
contamination

A

true

73
Q

> 85% concentration (syrup)

A

prone to recrystallization

74
Q

85% concentration (syrup):

A

self-preserving

75
Q

65 to 80% concentration (syrup)

A

stable

76
Q

<60% concentration (diluted conc.)

A

prone to
microbial growth which serves as an excellent media for yeast

77
Q

allow purified water or aqueous solution to pass slowly to a bed of crystalline sucrose packed or placed in a percolator thus dissolving the sucrose

A

Percolation

78
Q

faster and requires a shorter time; produces yello syrups;

A

Solution with aid of heat

79
Q

Excessive heat leads to

A

inversion of sucrose

80
Q

If inversion happens, sweetness of product is greatly __________ because invert
sugars are _________ than sucrose

A

altered; sweeter

81
Q

Performed in order to ensure maximum stability; time consuming

A

Solution without aid of heat

82
Q

ADR of paracetamol

A

hepatotoxicity

83
Q

pharmaceutical category of paracetamol syrup

A

Analgesic/Antipyretic

84
Q

(Paracetamol) Toxic dose

A

single dose of more than 10g

85
Q

(Paracetamol) Children of 2 years of age

A

dose of more than 3g

86
Q

Recommended maximum daily dose of paracetamol for adults is

A

4 grams

87
Q

Green vitriol; Pale bluish green crystal; Hygroscopic

A

FERROUS SULFATE SYRUP

88
Q

T/F: if ferric sulfate is brownish yellow, it can no longer be used as raw material

A

Ferric sulfate

89
Q

Pharmacologic Category of FeSO4

A

Hematinic

90
Q

For iron deficiency anemia; can increase hemoglobin
content of RBC

A

Hematinic (FeSO4)

91
Q

Iron is best absorbed on a/an __________ stomach usually taken 1 hour before
meal or 2 hours after meal

A

empty

92
Q

12% elemental iron by weight NH; least GI effect

A

Fe gluconate

93
Q

33% elemental iron by weight; fortified in dry
cereals; more stable than Fe sulfate

A

Fe fumarate

94
Q

20% elemental iron by weight; most readily by the GUT
but when added to dry cereals, it can promote spoilage and
rancidity; most common S/E is constipation

A

Fe sulfate

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