Introduction - [PPT Questions]

Both A and B

It is an element of organization.

A. Management guide

B. Organizational Planning

C. Product manual

D. Both A and B

E. None of the above

Chart

It is one of the tools of organization.

A. Chart

B. Division of responsibility

C. Both A and B

D. Both A and C

Both A and B

Section of Quality Control Division

A. Central release section

B. Chemical control section

C. Production section

D. Both A and B

E. None of the above

• Warehouse

• Quarantine

• Rejected

• Approved

Quality Control Division [4]

Chemical control section

The reagents during analytical testing is under ____ section?

Approved for use section

It is not a section of Quality control

A. Micro-biological section

B. Approved for use section

C. Chemical control section

D. All of the above

Batch

A specific homogeneous quantity of a drug produced according to a single manufacturing order

Batch size

Quantity in a batch

Lot number

Any distinct combination of letters or both w/c the complete history of the manufacturing,control,distribution of a batch or lot of a drug is determined by ________?

Component

Ingredient intended for the use in the manufacture.

A. Batch

B. Lot number

C. Component

D. QC Head

E. None of the above

C. Quality Control

Where random spot checking instead of 100% examination of the work process & product is performed.

A. Technology element

B. Aesthetic element

C. Quality Control

D. Quality assurance

E. None of the above

100% examination

Check all products

Spot checking

Random checking of selected products

Man

Dishonesty & fatigue is one cause of variation of:

A. Materials

B. Man

C. Machines

Machines

Agin & improper care is one cause of variation of:

A. Materials

B. Man

C. Machines

Capping

Partial or complete separation of the top or bottom of a tablet from the main body.

A. Picking

B. Capping

C. Lamination

D. Chipping

E. Mottling

Capping

_______- is a term used to describe the partial or complete separation of the top or bottom crowns of a tablet from the main body of the tablet.

Picking

Surface rough and has tiny holes due to sticking

Chipping

Cracks or breaks on the edges or surface of the tablet

Lamination

Complete separation of tablet into 2 or more layer

Mottling

Uneven distribution of colors (polcadotsU

Standard Operating Procedure

What does SOP stand for in pharmaceutical manufacturing?

A Standard Operating Procedure

B. Single Order Protocol

C. Super Operational Process

D. Strict Operating Practice

Product Marketing

Which of the following is not a core principle of cGMP

a. Documentation and record keeping

b. Equipment validation

c. Risk Management

d. Product Marketing

Product recalls

What is the consequence of non-compliance with cGMP regulations

a. Suspension of the product

b. Product recalls

c. Fines and penalties

d. AOTA

To ensure compliance with regulatory requirements FDA

What is the purpose of conducting regular audits in a cGMP-compliant facility

a. To identify opportunities for cost cutting

b. To ensure compliance with regulatory requirements FDA

c. To evaluate employee performance

d. To expedite product development processes

Suspension

A two-phase system with uniform dispersion of finely divided solid drug particles in a continuous phase of liquid or gas:

a. Suspension

b. Emulsion

c. Dispersion

d. Solution

• Dispersed phase

• Internal phase

In pharmaceutical suspensions, the dispersed phase is normally called:

a. External phase

b. Dispersed phase

c. Dispersion medium

d. Internal phase

I and III

Hydrophilic substances:

I. Does not alter the viscosity of the aqueous medium.

II. Easily wet by water.

III. Does not need wetting agent.

a. I and II

b. II and III

c. I and III

d. I, II and III

Surfactants

Wetting of hydrophobic substances can be modified by adding:

a. Emulsifying agents

b. Surfactants

c. Dispersion aids

d. Colloidal silica

I, II and III

To aid the dispersion of hydrophobic substances in a suspension, a formulation can use a water-insoluble hydrophilic material such as:

I. Colloidal silica.

II. Bentonite.

III. Veegum.

a. I and II

b. II and III

c. I and III

d. I, II and III

Packaging

The major concern for any adjuvant is its compatibility with the vehicle and the pharmaceutical ingredients. Which of the following adjuvants may be considered as the final adjuvant?

a. Preservative

b. Colorant

c. Perfume

d. Packaging

Wetting agent

Facilitating the connection between the active pharmaceutical ingredient and the excipients may be purpose of:

a. Wetting agent.

b. Buffering systems.

c. Preservatives.

d. Flavorant.

Suspending agent

Maintaining suspension appearance can be a

a.Sweetener.

b. Suspending agent

c. Wetting agent

d. Antioxidant

Silicone

If a suspension contains dihydrostreptomycin and penicillin, its glass container should be coated with;

a. Salicylates

b. Aluminum

c. Cap-liner

d. Silicone

Spray-drying

The particle size of the powders to be used in a suspension for dispersion should be reduced using

a. Levigation.

b. Trituration.

c. Spray-drying.

d. Precipitation

Lyophobic.

Non-wetting substances may be described as;

a. Hydrophilic.

b. Lyophobic.

c. Lyophilic.

d. Hemophobic.

Precipitation with the use of a buffer system.

Substances whose solubility depends on pH can be made into suspension using;

a. Dispersion method.

b. Precipitation with the use of a buffer system.

c. Precipitation by double decomposition.

d. Precipitation by either ethanol or propylene glycol.

Form a mechanical sheath around each particle.

Inclusive advice are used to prevent poor disease and usefulness after from surfactants because they:

a. Reduce interfacial tension.

b. Differ in viscosity.

c. Are used in high concentrations.

d. Form a mechanical sheath around each particle.

All of the choices.

Squeezing spines work by increasing the level of the dispersion medium. Which of the slavery may be used?

a. Magnesium silicate.

b. Polyacrylic acid.

c. CMC.

d. All of the choices.

Jet mill.

Microtendon of particles for use in suspension can be effectively achieved with the use of:

a. Planetary Mixer.

b. Jet mill.

c. Mortar and pestle.

d. Volumetric vacuum filler.