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MANUFACTURING PHARM > Part 1 > Flashcards

Part 1 Flashcards

1
Q

Most common diluent

A

Lactose

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2
Q

Type of superdisintegrant which cross link polyvinylpyrolidone

A

Crospovidone

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3
Q

Step by step instructions for performing operational tasks or activities

A

SOPs

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4
Q

3 Forms of Lactose as Diluent

A
  1. Monohydrate
  2. Anhydrous
  3. Spray-dried
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5
Q

What department in Manufacturing Company ensures compliance of company and its products with all pertinent regulations and laws about drugs and their marketing.

A

Regulatory Department

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6
Q

This is a type of granulation that pass through sieve #40

A

Fine Granules

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7
Q

Matching Type: Rotating Shell/Tumbling Mixers
1. Poor cross flow?
2. Solid-solid blending?
3. Better cross flow?

A. Double Cone Blender
B. Twin-shell/V-shell Blender
C. Drum-Type Blender

A
  1. C
  2. B
  3. A
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8
Q

Yellow no. 6

A

Sunset Yellow
Color: Orange

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9
Q

Type of Flavoring Technique:
Addition of intense flavor?

A

Overshadow

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10
Q

A synthetic organic colorant

A

Dyes

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11
Q

Type of document that contains the formulation, specifications, manufacturing procedures, QA requirements, and labeling of a finished product

A

Master Formula

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12
Q

Only inorganic salt used as diluent

A

Dibasic Calcium Phosphate

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13
Q

Imparts cohesiveness to powders causing them to from granules

A

Binder

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14
Q

Powder size enlargement to granules with an objective of ↑ flowability and compressibility

A

Granulation

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15
Q

Registered owner of drug product and formulation but subcontracts manufacturing.

A

Trader

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16
Q

Reduces friction between the tablet
and die wall to facilitate ejection from die cavity

A

Lubricant

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17
Q

Types of Packaging:
In direct contact with the product

A

Primary Packaging

18
Q

The dispersed globules come
together but do not fuse

A

Flocculation/Aggregation

19
Q

HLB Value of Solubilizer

A

15-20

20
Q

Synthetic Surfactants that are effective at acidic pH

A

Cationic

21
Q

What class are these preservatives?
- Thimerosal, Phenylmercuric nitrate

A

Organic Mercurial

22
Q

Type of Antioxidant:
react with heavy metals; EDTA, citric acid, tartaric acid

A

Antioxidant Synergists

23
Q

The components are combined by melting together and
cooled with constant stirring until congealed

A

Fusion

24
Q

Type of Sealing that uses liquid wetting agent to lower melting point between cap and body then bonds.

A

Thermal Coupling

25
Q

QC test for HEPA filter

A

Diocylphthalate Tes

26
Q

Type IV/NP

A

General Soda Lime Glass

27
Q

uses an indicator which if breached or missing can
provide evidence that tampering has occurred

A

Light-resistant

28
Q

This is a classification of containers that is impervious to air or any other gas

A

Hermetic

29
Q

A coating defect that includes reduced adhesion and detachment of the film

A

Blistering

30
Q

This is a problem encountered in flowability requirement that results to discharge which takes place only above hopper
outlets

A

Rat Holing

31
Q

Red no 3. Is Erythrosine. What is its color?
A. Blue
B. Orange
C. Pink
D. Red

A

C. Pink

32
Q

action of proving that premises,
systems or equipment work correctly and actually
lead to expected results

A

Qualification

33
Q

True or False. Too much binder can result to soft granules.

A

False

34
Q

A tablet defect which is due to excessive moisture and adhesion of material to the design embedded on the punch.

A

Picking

35
Q

The equipment used for roller compaction; used to compress powder into thin sheets

A

Chilsonator Roller Compactor

36
Q

This is an equipment in the Manufacturing Liquid Dosage Form that is jacketed to allow heating or cooling of contents;
Made of stainless.

A

Mixing Tank

37
Q

Flaking is a coating defect that has 2 types. Which type includes core swelling caused by excessive moisture uptake

A

Type II

38
Q

This is the oldest method in coating process.

A

Sugar coating

39
Q

The brand name, Splenda is an example of what non-nutritive (artificial) sweetener?

A

Sucralose

40
Q

What is the factor (_x) of your answer in the previous question?

A

1000x

41
Q

Facilitates the breakup of a tablet when in contact with aqueous medium

A

Disintegrant

MANUFACTURING PHARM (1 decks)

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