MODULE 2 Flashcards
This should cover all characteristics
that affect the proper performance,
purity, safety, and stability of the
product.
Finished Product
This should enumerate
the characteristics of all
the materials that go into
the product and the
permissible range of
purity of each ingredient
Raw Materials
Can be applied to either an O/W or
water in oil (W/O) type.
Emulsion
This is a concise and precise
statement of the ingredients that
comprises the product with their
corresponding percentage or weight.
Formulations
Is the process of
removing an
appropriate number of
items from a
population in order to
make inferences to the
entire population.
Sampling
Sample in which the different fractions of
the material have an equal probability of
being represented.
Random Sample
The complete sampling operations to be
performed on a defined material for a
specific purpose.
Sampling Procedure
Something that is very good and is
used to make judgements about the
quality of other things
Standard
This must be standardized so that
they yield results of comparable
precision and accuracy in the hands of
Testing Methods
This should be set for
everything that goes around the product.
Packaging Materials
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.
Transdermal Patch
A quantity of any drug produced during a
given cycle of manufacture.
Batch
Person responsible for performing the
sampling operations.
Sampler
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
Production
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.
Pharmaceutical Product
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.
Sample
Is the total of all actual or conceivable items of a
certain class under consideration.
Population
3 Types of Errors
Determinate Errors
Instrumental Errors
Personal Errors
Caused by analytical instruments which are found to be
‘out of calibration’.
Instrumental Errors
Calibrated by using standard
certified weight box.
Single-Pan Electric Balance
Errors caused due to either incorrect adoption of an assay method or
an incorrect graduation read out by an analyst.
Determinate Errors
Examples of Personal Errors
Physical Impairments
Learning Curve Syndrome
A person’s suffering from colour blindness may not be in a position to
assess colour-changes precisely.
Personal Errors
Calibrated using standard
solutions of known substances
UV Spectrophotometer
Calibrated using a buffer solution of known pH.
pH meter
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.
Suspension
It must spell out all information and instructions
that assures that variations in production will be
held to within acceptable established ranges.
Standard Operating Procedures (SOP)
A list of tests, reference to analytical
procedures, and proposed
acceptance criteria that includes the
concept of criteria for release and
shelf-life.
Specification
In addition to errors caused due to improper assay
methods or faulty instruments, it may also be due to
the analyst.
Personal Errors
Upon gravimetric analysis, a compound is precipitated from a solution
and the analyst believes that the analyte has been removed from the
solution completely.
Determinate Errors
An analyst used an UV spectrophotometer but failed to calibrate
before the testing of sample.
Determinate Errors
An analyst uses bifocals that he may not take the burette readings
accurately.
Personal Errors
A QC analyst weighs a sample powder to an uncalibrated balance.
Instrumental Errors
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.
Learning-Curve Syndrome
3 Examples of Determinate Errors
Gravimetric Analysis
Incomplete Chemical Reaction
Colour-Change at Endpoint
