MODULE 2

Question 1

This should cover all characteristics
that affect the proper performance,
purity, safety, and stability of the
product.

Answer 1

Finished Product

Question 2

This should enumerate
the characteristics of all
the materials that go into
the product and the
permissible range of
purity of each ingredient

Answer 2

Raw Materials

Question 3

Can be applied to either an O/W or
water in oil (W/O) type.

Answer 3

Emulsion

Question 4

This is a concise and precise
statement of the ingredients that
comprises the product with their
corresponding percentage or weight.

Answer 4

Formulations

Question 5

Is the process of
removing an
appropriate number of
items from a
population in order to
make inferences to the
entire population.

Answer 5

Sampling

Question 6

Sample in which the different fractions of
the material have an equal probability of
being represented.

Answer 6

Random Sample

Question 7

The complete sampling operations to be
performed on a defined material for a
specific purpose.

Answer 7

Sampling Procedure

Question 8

Something that is very good and is
used to make judgements about the
quality of other things

Answer 8

Standard

Question 9

This must be standardized so that
they yield results of comparable
precision and accuracy in the hands of

Answer 9

Testing Methods

Question 10

This should be set for
everything that goes around the product.

Answer 10

Packaging Materials

Question 11

Consist of a protective backing, a matrix
containing active drug, an adhesive that
allows the patch to adhere to the skin and a
release liner to protect the skin adhering
adhesive.

Answer 11

Transdermal Patch

Question 12

A quantity of any drug produced during a
given cycle of manufacture.

Answer 12

Batch

Question 13

Person responsible for performing the
sampling operations.

Answer 13

Sampler

Question 14

All operations involved in the preparation of a
pharmaceutical product, from receipt of materials,
through processing, packaging and repackaging,
labelling and re-labelling, to completion of the products

Answer 14

Production

Question 15

Any material or product intended for human or
veterinary use presented in its finished dosage
form or as a starting material for use in such a
dosage form, that is subject to control by
pharmaceutical legislation in the exporting state
and/or the importing state.

Answer 15

Pharmaceutical Product

Question 16

Is the finite number of objects selected from a
population. Representative materials to be
sampled include drug substances, raw
materials, packaging and printed materials,
intermediate
and final products.

Answer 16

Sample

Question 17

Is the total of all actual or conceivable items of a
certain class under consideration.

Answer 17

Population

Question 18

3 Types of Errors

Answer 18

Determinate Errors
Instrumental Errors
Personal Errors

Question 19

Caused by analytical instruments which are found to be
‘out of calibration’.

Answer 19

Instrumental Errors

Question 20

Calibrated by using standard
certified weight box.

Answer 20

Single-Pan Electric Balance

Question 21

Errors caused due to either incorrect adoption of an assay method or
an incorrect graduation read out by an analyst.

Answer 21

Determinate Errors

Question 22

Examples of Personal Errors

Answer 22

Physical Impairments
Learning Curve Syndrome

Question 23

A person’s suffering from colour blindness may not be in a position to
assess colour-changes precisely.

Answer 23

Personal Errors

Question 24

Calibrated using standard
solutions of known substances

Answer 24

UV Spectrophotometer

Question 25

Calibrated using a buffer solution of known pH.

Answer 25

pH meter

Question 26

Dosage form that should be stable and
be re-dispersed homogeneously with
moderate shaking and can be poured
easily throughout its shelf life, with
neither the particle size distribution,
the crystal form, nor the physiological
availability of the suspended active
ingredient changing appreciably with
time.

Answer 26

Suspension

Question 27

It must spell out all information and instructions
that assures that variations in production will be
held to within acceptable established ranges.

Answer 27

Standard Operating Procedures (SOP)

Question 28

A list of tests, reference to analytical
procedures, and proposed
acceptance criteria that includes the
concept of criteria for release and
shelf-life.

Answer 28

Specification

Question 29

In addition to errors caused due to improper assay
methods or faulty instruments, it may also be due to
the analyst.

Answer 29

Personal Errors

Question 30

Upon gravimetric analysis, a compound is precipitated from a solution
and the analyst believes that the analyte has been removed from the
solution completely.

Answer 30

Determinate Errors

Question 31

An analyst used an UV spectrophotometer but failed to calibrate
before the testing of sample.

Answer 31

Determinate Errors

Question 32

An analyst uses bifocals that he may not take the burette readings
accurately.

Answer 32

Personal Errors

Question 33

A QC analyst weighs a sample powder to an uncalibrated balance.

Answer 33

Instrumental Errors

Question 34

An analyst must practise
a new assay method employing ‘known’
samples
before making an attempt to tackle an unknown
sample, thereby minimising the scope of personal
errors.

Answer 34

Learning-Curve Syndrome

Question 35

3 Examples of Determinate Errors

Answer 35

Gravimetric Analysis
Incomplete Chemical Reaction
Colour-Change at Endpoint