Part 1

Question 1

Most common diluent

Answer 1

Lactose

Question 2

Type of superdisintegrant which cross link polyvinylpyrolidone

Answer 2

Crospovidone

Question 3

Step by step instructions for performing operational tasks or activities

Answer 3

SOPs

Question 4

3 Forms of Lactose as Diluent

Answer 4

1. Monohydrate
2. Anhydrous
3. Spray-dried

Question 5

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

Answer 5

Regulatory Department

Question 6

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

Answer 6

Fine Granules

Question 7

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

Answer 7

1. C
2. B
3. A

Question 8

Yellow no. 6

Answer 8

Sunset Yellow
Color: Orange

Question 9

Type of Flavoring Technique:
Addition of intense flavor?

Answer 9

Overshadow

Question 10

A synthetic organic colorant

Answer 10

Dyes

Question 11

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

Answer 11

Master Formula

Question 12

Only inorganic salt used as diluent

Answer 12

Dibasic Calcium Phosphate

Question 13

Imparts cohesiveness to powders causing them to from granules

Answer 13

Binder

Question 14

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

Answer 14

Granulation

Question 15

Registered owner of drug product and formulation but subcontracts manufacturing.

Answer 15

Trader

Question 16

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

Answer 16

Lubricant

Question 17

Types of Packaging:
In direct contact with the product

Answer 17

Primary Packaging

Question 18

The dispersed globules come
together but do not fuse

Answer 18

Flocculation/Aggregation

Question 19

HLB Value of Solubilizer

Answer 19

15-20

Question 20

Synthetic Surfactants that are effective at acidic pH

Answer 20

Cationic

Question 21

What class are these preservatives?
- Thimerosal, Phenylmercuric nitrate

Answer 21

Organic Mercurial

Question 22

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

Answer 22

Antioxidant Synergists

Question 23

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

Answer 23

Fusion

Question 24

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

Answer 24

Thermal Coupling

Question 25

QC test for HEPA filter

Answer 25

Diocylphthalate Tes

Question 26

Type IV/NP

Answer 26

General Soda Lime Glass

Question 27

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

Answer 27

Light-resistant

Question 28

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

Answer 28

Hermetic

Question 29

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

Answer 29

Blistering

Question 30

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

Answer 30

Rat Holing

Question 31

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

Answer 31

C. Pink

Question 32

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

Answer 32

Qualification

Question 33

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

Answer 33

False

Question 34

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

Answer 34

Picking

Question 35

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

Answer 35

Chilsonator Roller Compactor

Question 36

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

Answer 36

Mixing Tank

Question 37

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

Answer 37

Type II

Question 38

This is the oldest method in coating process.

Answer 38

Sugar coating

Question 39

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

Answer 39

Sucralose

Question 40

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

Answer 40

1000x

Question 41

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

Answer 41

Disintegrant