QA & QC

DOP Test

What is used in assessing efficiency of HEPA filters?

Rabbit

In the assay of Dextran injection wherein the activity assayed is absorption of iron, what is the animal used?

Klebsiella pneumoniae

Which of the following has been identified to be microbial contaminant in hand cream?

90-110%

What is the typical range of acceptance criteria for assay results as found in the labeled claim?

Proximate

Type of alkaloidal assay where the total alkaloids are determined:

Pyrogens

Limulus amoebocyte lysate (LAL) assay method is applicable in the determination of _______.

Staphylococcus aureus

In the microbial assay of antibiotics, the microorganism used for Penicillin G is _______.

90%

The period of stability of a preparation is the time from the date of manufacture of the formulation until its chemical or biological activity is not less than ______ of labeled potency.

Stability

The length of time that a product is within required specification is referred to as what?

Tissue culture

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

Quality is everybody’s business

Total quality means:

Performance defect

Suppository that does not melt at body temperature is what kind of defect?

Type II

Water attack test is used in this type of glass container

Type I

The type of glass most suitable for parenteral preparation is _______.

Rabbit

Test animal used in Pyrogen Testing of parenteral products.

Sheep

Test animal used in the assay of Heparin.

2-3kg

This is the acceptable tablet hardness range of chewable tablets:

1%

A passing tablet friability result is a maximum weight loss of not more than what percent of the weight of the tablets being tested.

37C +/- 2C

Disintegration test is done at this temperature

50 rpm

The operating speed for paddle in a dissolution apparatus is:

Methylene blue

Dye used in leaker test

Friabilator

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

Specificity

In validation procedures the ability to assess unequivocally the analyte in the presence of components that may be expected to be present is called _______.

Robustness

In analytical methods, the measure of its capacity to remain unaffected by small but deliberate variations in method parameters and provides an indication of its reliability during normal usage is called _______.

Type II

Water attack test as an official test for glass is done on _______.

10

Content uniformity test is initially conducted in _____ tablets.

Quarantine area

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

Content uniformity

A test which is determined by selecting not less than 30 tablets from each production batch and assaying 10 tablets individually as directed in the assay of the individual compendial monograph.

Dogs

The bioassay for Parathyroid Injection is based on measuring the increase in serum calcium in _______.

Chicken

Animal employed for the biological assay of oxytocin injection.

Major Defect

A defect that may affect the function of an object and therefore, may render the product useless.

Military standard

A common sampling plan that uses master tables to interpret the results:

Sampling

The process of removing an appropriate number of items from a population in order to make interferences to the entire population is called:

90mg

Potency of a 100mg tablet at the expiry date:

Hardness

This is also known as “crushing strength”