TOPIC QUIZ: Quality Assurance & Control

Which of the following is not a function of quality control?

Auditing

Defined as the sum of all activities and responsibilities required to ensure that the medicine that reaches the patient is safe, effective, and acceptable to the patient

Pharmaceutical Quality Assurance

Which of the following chemical interactions is recognized as a major cause for product instability?

Oxidation-Reduction

The following are factors that can be manipulated to accelerate instability, EXCEPT:

Concentration

Which are unsaturated fatty acids?

III, IV, V, VI

Predict which fatty acid will undergo auto-oxidation easily?

Linoleic Acid

Which of the following preventive measures can be employed to retard or minimize the oxidation of pharmaceutical products containing fatty acids?

I. Use of well-closed containers

II. Store product at low temperatures

III. Use of amber colored containers

IV. Addition of anti-oxidants

II, III, IV

Short chain fatty acids are derived from:

Bacterial Metabolism

Intentional or deliberate type of adulteration done by the addition of an inferior material to an article with an intent to defraud.

Sophistication

The temperature used when conducting Accelerated Stability Studies

40°C

The following may be useful when performing microbiological assay of antibiotics, EXCEPT:

Staining Method

The systemic injection test is designed to determine systemic responses of animals to plastics and other polymers. The test animal to be used is:

Albino Mice

The test organism used in the Cylinder Plate Method of assay of Penicillin G

Staphylococcus aureus

In the assay for elastomeric closures using direct contact, elution test, what is the test animal used?

tissue culture

A test which involves selecting NLT 30 tablets each production and assaying 10 tablets individually as directed in the assay of the official compendial monograph

Content uniformity test

It refers to the ability of the tablets to resist chipping, abrasion or breakage under conditions of storage transportation and handling before usage.

Hardness

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

Stokes Monsanto HT

The most preferred medium in dissolution testing is:

Water

A parenteral is declared to be pyrogenic if the total rise in temperature of the rabbits is:

More than 3.3°C in the 8 rabbits

Assay method that determines the presence of pyrogens in injectables:

Rabbit test and Limulus amoebocyte lysate test

Pyrogen test is performed in:

Rabbits

Pyrogen test in vitro:

LAL method

The dye used in the leaker test

Methylene blue

Which of the following is not an adhesion test for TDS?

Leak Test

It refers to the ability of the tablets to resist chipping, abrasion or breakage under conditions of storage transportation and handling before usage

Hardness

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

Stokes Monsanto HT

This is also known as "crushing strength"

Hardness

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

Friability test

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

95 to 105%

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

20 tablets

The amount of dissolved drug can be determined by

Dissolution tester

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

Quality

Quality control guarantees which of the following

All of these