M6- QA & QC

It refers to the sum of all factors which contribute directly or indirectly to the safety, effectiveness and reliability of a product.

A. Safety

B. Purity

C. Quality

D. Efficacy

E. All of these

Quality

It refers to the nearness of a value to a target value.

A. Accuracy

B. Defect

C. Precision

D. Error

E. Any of these

Accuracy

It is the partial or complete separation of the top or bottom of a tablet from the main body

A. Lamination

B. Capping

C. Mottling

D. Picking

Capping

Which of the following is NOT used in Method II of USP test for bulk density?

A. 250 mL graduated cylinder

B. No.18 screen

C. Volumeter

D. Baffle box

250 mL graduated cylinder

Disintegration is an essential attribute of this dosage form

A. Plain coated tablet

B. Hard gelatin capsule

C. Chewable tablet

D. All of the above

Plain coated tablet

This is also known as "in-vitro" pyrogen test:

A. Rabbit test

B. Bacterial endotoxin test

C. LAL test

D. Both A and C

E. Both B and C

Both B and C

The method of assay for vitamin B12 and calcium pantothenate is by:

A. Fluorometry

B. Colorimetry

C. Turbidimetry

D. Nephelometry

E. Spectrophotometry

Turbidimetry

Military standard table is also known as:

A. Government sampling plan

B. MIL-STD-105D

C. ABC-STD 105D

D. All of the choices

All of the choices

Microbial assay of an antibiotics maybe performed using the following except:

A. Test tube inoculation

B. Cylinder plate method

C. Paper disk method

D. Titration process

Titration process

While waiting for its release by the quality control, materials are held in:

A. Packing area

B. Quarantine area

C. Analytical laboratory

D. Biological laboratory

Quarantine area

The type of glass most suitable for parenteral preparation is

A. Type I

B. Type II

C. Type III

D. NP

Type I

Gypsum in silica gel G is used as:

A. Disintegrant

B. Dessicant

C. Binder

D. Diluent

E. Antiadherent

Binder

Pyrogen test in vitro:

A. Colorimeter

B. Cylinder-plate method

C. Fluorophotometer

D. LAL method

LAL method

A passing tablet friability result is a maximum weight loss of NMT what % of the weight of the tablets being tested:

A. 0.50%

B. 1.00%

C. 1.50%

D. 2.00%

E. 2.50%

1.00%

A microbial assay for antibiotics that measure the diameter of the zones of microbial growth inhibition in a solid nutrient medium

A. Cylinder plate method

B. Broth dilution method

C. Turbidimetric method

D. All of these

E. None of these

Cylinder plate method

What is the number of tablets required in weight variation test?

A. 10 tablets

B. 15 tablets

C. 20 tablets

D. 25 tablets

E. 30 tablets

20 tablets

The test for content uniformity is required for

A. Film-coated tablets

B. Solutions for inhalation

C. Suspensions

D. Liquid-filled soft capsules

Suspensions

Apparatus 1 in a dissolution apparatus:

A. Basket

B. Paddle

C. Reciprocating cylinder

D. Flow-through cell

E. Paddle over disk

Basket

Content uniformity test is initially conducted in:

A. 10 tablets

B. 20 tablets

C. 15 tablets

D. 5 tablets

10 tablets

Pyrogen test is performed in:

A. Pigeons

B. Mice

C. Rabbits

D. Guinea pigs

Rabbits

LAL test is applicable in the determination of:

A. Microorganism

B. Pyrogens

C. Chemical impurities

D. All of these

E. None of these

Pyrogens

It refers to the nearness or closeness of the measured values with one another:

A. Accuracy

B. Reproducibility

C. Precision

D. Specificity

E. None of these

Precision

The type of container which is impervious to air or any other gas under the ordinary or customary conditions of handling, shipping, storage and distribution.

A. Tight-container

B. Well-closed container

C. Single-unit container

D. Hermetic container

Hermetic container

Hydrolysis products of ASA

A. Acetic acid + sodium hydroxide

B. Acetic acid + salicylic acid

C. Salicylic acid + sodium hydroxide

D. Sodium salicylate + water

Acetic acid + salicylic acid

Given a tablet thickness of 0.47 cm, what should be the acceptable range?

A. 0.4465 to 0.4935 cm

B. 0.4348 to 0.5050 cm

C. 0.4230 to 0.5170 cm

D. 0.3525 to 0.5875 cm

E. 0.3760 to 0.5640 cm

0.4465 to 0.4935 cm

This class of drugs require batch certification from the Bureau of Food and Drugs

A. Anti-convulsants

B. Antibiotics

C. Analgesic

D. Vitamins

Antibiotics

What microorganism is used in the microbial assay test for vitamin B12?

A. Lactobacillus shirota

B. Lactobacillus plantarum

C. Lactobacillus leichmanii

D. Lactobacillus bifidus

E. All of these

Lactobacillus leichmanii

This is also known as "crushing strength"

A. Hardness

B. Thickness

C. Friability

D. Content uniformity

E. Weight variation

Hardness

In microbial assay, the instrumental method used to prepare THE INOCULUM IS:

A. Nephelometry

B. Flame spectroscopy

C. IR spectroscopy

D. Turbidimetry

E. Spectrophotometry

Turbidimetry

The Philippines belong to what climatic zone

A. I

B. II

C. III

D. None of the above

None of the above

What tablet attribute is correlated with the biological activity of the active ingredients?

A. Hardness

B. Dissolution

C. Friability

D. Disintegration

E. Thickness

Dissolution

A fundamental vibration of atoms in which the distance increases or decrease along the bond axis:

A. Scissoring

B. Deformation

C. Stretching

D. Wagging

E. Twisting

Stretching

The round bottom flask used for the dissolution rate in the evaluation of tablets should be submerge in constant temperature water bath maintained at what temperature.

A. 37 °C

B. 25 °C

C. 40 °C

D. 30 °C

37 °C

One of the following is NOT an in-process control for tablet:

A. Bioavailability

B. Hardness and thickness

C. Weight variation

D. Disintegration

Bioavailability

A test that expose tablets to rolling and repeated shocks to determine the weight loss on tablets

A. Disintegration test

B. Hardness test

C. Thickness test

D. Friability test

E. Dissolution test

Friability test

Describes how close a measured value is to the true value.

A. Accuracy

B. Precision

C. Range

D. Standard deviation

Accuracy

The basket rack assembly is a compound of which of the following instrument?

A. Hardness tester

B. Cornier caliper

C. Disintegration apparatus

D. Friabilator

E. FTIR

Disintegration apparatus

The suitability of plastic materials intended for use as a container of drug products is determined through what type of test?

A. Biological Reactivity Test, In Vitro

B. Biological Reactivity Test, In Vivo

C. Both a and b

D. None of the above

Biological Reactivity Test, In Vitro

Common component of cap liners, stoppers, and parts of dropper assemblies:

A. Metal

B. Plastic

C. Glass

D. Rubber

Rubber

A method used to assay Vitamin B12 and Ca panthothenate is by:

A. Iodimetry

B. Micro-bio/ turbidimetric

C. Fluorometry

D. Iodometry

Micro-bio/ turbidimetric

A tablet friability apparatus also test the friability of this dosage form

A. Soft gelatin capsule

B. Hard gelatin capsule

C. Liquid fill capsule

D. None of the above

None of the above

Samples of raw materials in the quarantine area will not be subjected to this test:

A. Physical and organoleptic examination

B. Leaker test

C. Potency assay

D. Microbiological test

Leaker test

The level in microbiological environmental monitoring is that level of microorganism that shows a potential drift from normal operating procedure.

A. Alert level

B. Action level

C. Both a and b

D. None of the above

Alert level

In the manufacture of sterile parenteral solutions all added raw materials must be sterile.

A. Necessary

B. Not necessary

C. Always

D. None of the above

Not necessary

The gas that is used in gas sterilization is:

A. Oxygen

B. Ethylene oxide

C. Carbon dioxide

D. Nitrogen

Ethylene oxide

It refers to the ability of a tablet to withstand abrasion in packaging, handling and shipping.

A. Content uniformity

B. Friability

C. Crushing strength

D. Hardness

E. Thickness

Friability

Quality control guarantees which of the following?

A. Drug product is free of impurities

B. Drug product is physically and chemically stable

C. Drug product contains the amount of active

ingredients as stated in the label

D. Drug product provides optimal release of active ingredients

E. All of these

All of these

A hardness tester that operates on the same mechanical principle as ordinary pliers:

A. Stokes-Monsanto HT

B. Pfizer HT

C. Strong cobb HT

D. Schleuniger HT

E. Erweka HT

Pfizer HT

LAL is an aqueous extract of the circulating amebocytes obtained from:

A. Horse

B. Crab

C. Horseshoe crab

D. Mice

E. Dogs

Horseshoe crab

What tablet attribute is correlated with the biological availability of the active ingredient.

A. Disintegration

B. Dissolution

C. Content uniformity

D. None of the above

Dissolution

A critical defect that would stop the packaging line operations:

A. Wrong labels

B. Misaligned labels

C. Inverted labels

D. Smeared labels

Wrong labels

A type of assay performed with microorganisms, like bacteria, yeasts and molds

A. Bio assay

B. Microbial assay

C. Bacterial assay

D. Fungal assay

E. Viral assay

Microbial assay

What is the minimum number of rabbits used in pyrogen test?

A. One

B. Two

C. Three

D. Four

E. Five

Three

Which question is used to predict the shelf life of a drug product?

A. Michaelis-Menten equation

B. Arrhenius theory

C. Hixson-Crowell equation

D. Stokes equation

Arrhenius theory

What is the required disintegration time for sublingual tablets like isoproterenol HCl CT?

A. 3 min.

B. 30 min.

C. 1 hr.

D. 2 hrs.

E. 3 hrs

3 min.

In disintegration, enteric-coated tablets must

A. Show no evidence to disintegration after 30 minutes in simulated gastric fluid

B. Show no evidence to disintegration after 30 minutes in simulated intestinal fluid

C. In simulated intestinal fluid, they should disintegrate in 2 hours plus the time specified

D. In simulated gastric fluid, they should disintegrate in 2 hours plus in time specified

In simulated intestinal fluid, they should disintegrate in 2 hours plus the time specified

Which is not a biological indicator in the validation of a moist heat sterilization

A. Bacillus stearothermophilus

B. Bacillus subtilis

C. Bacillus coagulans

D. None of the above

None of the above

Friability testing is done using a Roche friability that must be set to ensure:

A. 10 falls of tablets

B. Either A or B

C. 100 falls of tablets

D. 100 rpm

100 rpm

These are the substance or bacterial components that cause fever or febrile reactions

A. Toxins

B. Pyrogens

C. Enzymes

D. Exotoxins

E. Antigens

Pyrogens

Performs and evaluate microbiological assay, sterility, pyrogen, and bacteriological test, safety or acute toxicity test.

A. Material inspection section

B. Analytical laboratory

C. Biological testing

D. Specification and analytical laboratory

Biological testing

The amount of dissolved drug can be determined by:

A. Friabilator

B. Dissolution tester

C. Hardness tester

D. Moisture analyzer

E. Spectrophotometer

Dissolution tester

What is the other name of Koettstorfer number?

A. Acid value

B. Saponification value

C. Ester value

D. Iodine value

Saponification value

Content uniformity test is used to ensure which of the following quality in tablet products:

A. Disintegration

B. Purity

C. Bioavailability

D. Potency

Potency

Pharmaceutical articles like raw materials must not harbor this organism except.

A. Staphylococcus aureus

B. Pseudomonas aeruginosa

C. Salmonella

D. None of the above

None of the above

The water attack test determines the chemical resistance to water of what type of glass?

A. Type I

B. Type II

C. Type III

D. NP

Type II

When packaging and storage requirements specifies a "hermetic container" it is understood that;

A. Contents are protected from extraneous solids

B. Contents are protected from extraneous solids and liquids

C. Contents are protected from extraneous solids, liquids and vapors

D. Contents are protected from extraneous solids, liquids, vapors and gas

Contents are protected from extraneous solids, liquids, vapors and gas

In disintegration test, the particles must pass through sieve # _____

A. 10

B. 20

C. 40

D. 60

E. 80

10

What are the weight variations limits if the computed average for a batch of tablet is 100 mg?

A. 95mg to 105 mg

B. 80mg to 120 mg

C. 92.50mg to 107.50 mg

D. 90mg to 110 mg

E. 85 mg to 115 mg

90mg to 110 mg

LAL in bacterial test is also known as:

A. Limulus amebocyte lysate

B. Linlus amebocyte lysate

C. Linnaeus amebocyte lysate

D. None of these

Limulus amebocyte lysate

Standard Operating Procedures (SOP):

A. Concerned with record keeping

B. Step by step method on how to go about a job

C. Done to facilitate recall

D. All of these are correct

All of these are correct

The quality of water recommended in the preparation of parenteral solutions is

A. Sterile purified water

B. Purified water

C. Water for injection

D. Sterile water for injection

Water for injection

The minimum time period covered by the data for long term stability studies is

A. 6 months

B. 12 months

C. 18 months

D. None of the above

12 months

A tablet hardness tester that uses a coil spring mechanism to break the table

A. Strong cobb HT

B. Pfizer HT

C. Erweka HT

D. Stokes Monsanto HT

E. Schleuniger HT

Stokes Monsanto HT

In validation procedures, what is the degree of agreement among individual test results when the method is applied repeatedly to multiple sampling of a homogeneous sample?

A. Precision

B. Accuracy

C. Specificity

D. None of the above

Precision

An amber glass bottle for an oral syrup preparation is considered light resistant if it allows not more than what percent of light to be transmitted?

A. 10% at any wavelength in range from 290 to 450 nm

B. 15% at any wavelength in range from 290 to 450 nm

C. 20% at any wavelength in range from 290 to 450 nm

D. 25% at any wavelength in range from 290 to 450 nm

10% at any wavelength in range from 290 to 450 nm

A parenteral is declared pyrogenic if the temperature rise in rabbits is:

A. Less than 1.4 °C in the 9 readings of the 3 rabbits

B. 0.6 °C in in the 1 of the 9 readings

C. >1.4 °C in the 9 readings of the 3 rabbits

D. None of the above

>1.4 °C in the 9 readings of the 3 rabbits

A decision to accept is made in the pyrogen test if the temperature rise in one rabbit is:

A. Less than 0.5C

B. Equal to 0.5C

C. More than 0.5C

D. Equal or less than 0.5C

E. Equal to or more than 0.5C

Less than 0.5C

If the bacterial endotoxin limit of a dosage form is 0.25EU/mL it means all components of the preparations should contribute

A. less than or equal to 0.25EU/mL

B. greater than or equal to 0.25EU/mL

C. <0.25EU/mL

D. None of the above

<0.25EU/mL

A test that measures the amount of time for a given percentage of the drug substance in a tablet to go into solution under a specified set of condition.

A. Friability

B. Dissolution test

C. Hardness test

D. Thickness test

E. Disintegration test

Dissolution test

All of the following are physicochemical properties of the drug which can affect dissolution rate of the drug from a dosage form, EXCEPT:

A. Solubility

B. Particle size

C. Method of granulation

D. Polymorphism

E. Solid phase characteristics of the drug

Method of granulation

The temperature wherein the refrigerator is thermostatically maintained is:

A. 36F and 46F

B. 46F and 59F

C. -13F and 14F

D. -23F and 34F

36F and 46F

The type of alkaloidal assay where the total alkaloids are determines is:

A. Ultimate

B. Specific

C. Proximate

D. Precision

Proximate

What biological animal is used when conducting pyrogen test?

A. Dogs

B. Horses

C. Rabbits

D. Frogs

E. Rats

Rabbits

Safety and Toxicity test are conducted using:

A. Rabbits

B. Dogs

C. White mice

D. Guinea pig

White mice

The initial content uniformity test is conducted using:

A. 10 tablets

B. 15 tablets

C. 20 tablets

D. 25 tablets

E. 30 tablets

10 tablets

An instrument that is used to determine tablet friability

A. Dissolution apparatus

B. Friabilator

C. Hardness tester

D. Disintegration apparatus

E. Moisture analyzer

Friabilator

An instrument that measures the durability of tablets to withstand a shock and abrasion during transport.

A. Spectrophotometer

B. Refractometry

C. Hardness tester

D. Friabilator

E. Coulter counter

Friabilator

The quality of water recommended in the preparation of compedial dosage forms is

A. Deionized water

B. Distilled water

C. Purified water

D. Water for injection

Purified water

Animal employed for the biological assay of oxytocin injection

A. Pigeon

B. Rabbit

C. Chicken

D. Rat

Chicken

Treated soda lime glass is classified as

A. Type I

B. Type II

C. Type III

D. NP

Type II

When packaging and storage requirements specifies a "tight container" it is understood that;

A. Contents are protected from extraneous solids

B. Contents are protected from extraneous solids and liquids

C. Contents are protected from extraneous solids, liquids and vapors

D. Contents are protected from extraneous solids, liquids, vapors and gas

Contents are protected from extraneous solids, liquids and vapors

What is the tolerable limit/allowance in thickness test for tablets?

A. 85-115%

B. 87.50 to 112.50%

C. 90 to 110%

D. 92.5 to 107.5%

E. 95 to 105%

95 to 105%

The experimental way of determining when equivalent amounts of reactants have reacted together is:

A. Titration

B. Masking

C. Standardization

D. All of these

E. None of these

Titration

In the repeat test for pyrogens using a total of eight rabbits, the requirement is met if the total rise in temperature is:

A. Less than 3.3 C

B. Equal to 3.3C

C. More than 3.3C

D. Equal to or less than 3.3C

E. Equal to or more than 3.3C

Equal to or less than 3.3C

Given a tablet thickness of 0.47 cm, what should be the accepted range?

A. 0.4465-0.4935 cm

B. 0.4348-0.5050 cm

C. 0.4230-0.5170 cm

D. 0.3525-0.5875 cm

0.4465-0.4935 cm

A belonging to climatic zone IV is officially described as

A. Temperate

B. Hot, humid

C. Hot, dry

D. None of the above

Hot, humid

A QC test that measures the time required for the tablets to undergo disintegration under specified set of conditions

A. Dissolution test

B. Hardness test

C. Friability test

D. Disintegration test

E. Content uniformity test

Disintegration test

In column Chromatography, the separation of the sample mixture into a series of narrow bands in a column is called:

A. Chromatogram

B. Eluent

C. Development

D. A and B

Development

Fluorometry is the official method used in the analysis of which vitamin?

A. Nicotinamide

B. Riboflavin

C. Pyridoxine

D. Folic acid

E. Cyanocobalamin

Riboflavin

Powdered glass test is done on the following except

A. Borosilicate glass

B. Soda lime glass

C. Treated soda lime glass

D. General purpose soda lime glass

Treated soda lime glass