HERA RAUF

7TH SEMESTER (A)

IPQC ASSIGNMENT
PHARMACEUTICAL QUALITY
CONTROL AND MANAGEMENT
SUBMITTED TO: DR. KHURRAM
REHMAN
 INPROCESS QUALITY CONTROL

What is IPQC ?
IPQC is concerned with providing accurate, specific and definite
description of the procedures to be employed from the receipt of raw
materials to the release of the finished dosage form.
In-process quality control tests are simply routine checks that are
performed during production. They are those tests carried out before
manufacturing process is completed to ensure that established product
quality is met before they are approved for consumption and marketing.

What is its significance?

To minimize human errors
Provide accurate definite description of the procedures to be
employed.
It is a planned system to identify material equipment processes and
operation.
To detect the error.
To enforce the flow of manufacturing and packaging operation
according to established route and practice.
To pin point the responsibility to the personnel involved in the
operation of the entire process
To detect any abnormality immediately and indicate the kind of
action needed to correct the problem.
IPQC of tablets.
Uniformity of container content.
This test is done to ensure that every tablet contains the amount of drug
substance intended with little variation within a batch. In this test 30
tablets are randomly selected for the sample and at least 10 of them
assayed individually.9 of the 10 tablets must contain not less than 85%
or more than 115% of labeled drug content. 10th tablet may not contain
less than 75% or more than 125% of labeled content. If these conditions
are not met then the remaining tablet from the 30 must be assayed
individually and none may fall outside 85% to 115%.
Friability.
It is the tendency of the tablets to powder chip or fragment and this can
affect the elegance appearance, consumer acceptance of the tablet, and
also add to tablet’s weight variation and or content uniformity variation.
A friabilator is used to evaluate the ability of the tablet to withstand
abrasion in packaging, handling and shipping. Friability test can be
determined in a laboratory by Roche friabilator. This consist of a plastic
chamber that resolves at 25rpm, dropping the tablets through a distance
of six inches in the friabilator, which is then operated for 100
revolutions. The tablets are then re weighed. Tablets that lose less than
0.5% to 1.0% of the tablet weigh are considered acceptable.

Disintegration.
It is the time required for the tablet to break into particles. This test is a
measure only of the time required under a given set of conditions for
group of tablets to disintegrate into particles. The endpoint of the test
(complete disintegration) is achieved when no tablet fragments remain
on the screen. If one or two tablets fail to disintegrate, repeat test on 12
additional tablets, at least 16 of 18 tested tablets should pass.
Tablet thickness.
The thickness of a tablet depends on the upper and lower punches at the
moment of compression. It can be tested using Vernier caliper. Its range
is from +/- 5.0%
Hardness.
It is the load required to crush the tablet when placed on its edge. It
determines the need for pressure adjustments on the tableting machine. It
determines the need for pressure adjustments on the tableting machine.
The hardness test is done by:
 Monsanto tester
 Strong-cobb tester
 Pfizer tester
 Erwica tester

Weight variation
The volumetric fill of the die cavity determines the weight of the
compressed tablet. The weight of the tablet is the quantity of the
granulation that contains the labeled amount of the therapeutic
ingredient.
First take 20 tablets and measure the individual weight of each tablet.
Take average weight of 20 tablets. Compare the individual weight of the
tablets with average weight. Not more than 2 tablets should deviate from
average tablet weight by % deviation and none should deviate more than
twice the percentage.

Dissolution test.
Dissolution test is performed to check the percentage release from the
dosage forms the tablet. When the tablet disintegrates it breaks into
small particles which offers a great surface area to the dissolving media
and drug will dissolve.

Potency
Potency tests are assays that estimate the quantity of an active ingredient
in drug.
 Blister or strip sealing test
 Take the required number of strips/blisters as mentioned in
annexure. Check the quality of strips/blisters for any damages.
 Tie the collected strips/blisters with a rubber band.
 Ensure that all strips/ blisters are dipped in water and close the lid.
 Connect opening of the desiccator to the vacuum pump.
 Apply a vacuum of 300 mm of Hg and close the knob of the
desiccator slowly and open the lid remove the strips/blisters.
 Keep the vacuum for 30 sec.
 Release the vacuum by opening the knob of the desiccator slowly
and open the lid remove the strips/blisters.
 Wipe out the traces of water from the strips/blisters by using line
free duster.
 Open the pocket of strips by using scissors to remove the tablets.
 Open he blisters manually.
 Check for any traces of water inside the strips/blisters. No. of
tablets and which have become wet, should not be more than 1%.
IPQC OF INJECTIONS

Environmental control
 Traffic control: personnel should be admitted to the aseptic areas
only after following the rigidly prescribed procedures.
 Surface disinfection personnel
 Air control that is by HEPA filters

ph
2 different methods used in measurement of ph:
1. dip a piece of ph paper into the sample.
2. ph meter.
 Viscosity
Ostwald viscometers are used to determine the viscosity. It consists of a
U shaped glass tube held vertically in a controlled temperature bath.
Liquid is drawn into the upper bulb by suction, then allowed to flow
down through the capillary into the lower bulb. Two marks, one above
and one below the volume indicates a known volume. The time taken for
the level of the liquid to pass between these marks is proportional to the
kinematic viscosity. The time required for the test liquid to flow through
a capillary of a known diameter of a certain factor between two marked
points is measured. By multiplying the time taken by the factor of the
viscometer, the kinematic viscosity is obtained.
Osmolality
Osmolality is a count of the number of particles in a fluid sample. The
osmolality of a solution can be measured by osmometer. Freezing point
depression osmometer is widely used.
Conductivity measurement
Conductivity is measured by conductometer. It is measured by the
conductivity of the vehicle used in sterile preparation.the conductivity of
the pure water is 0.55 microsiemens/cm.
Temperature for heat sterilization
It is important to maintain a constant temperature during heat
sterilization of product. The temperature changes may cause some
undesirable changes like change in potency, change in isotonicity etc.
The temperature can be determined by normal thermometer, digital
thermometer.
Volume check
An injection container is filled with a volume in slight excess of the
labelled size Physical and chemical tests
Determination of filled volume:
 10 mL or more: 1 container
 3-10 mL: 3 containers
 Less than 3 mL: 5 containers

Leakage test
Leakage test is employed to test the package integrity. Package
integrity reflects its ability to keep the product in and to keep
potential contamination out”. It is because leakage occurs when a
discontinuity exists in the wall of a package that can allow the
passage of gas under pressure or concentration differential existing
across the wall. Leakage test can be done by dye bath test.
Dye Bath Test
The test container is immersed in a dye bath. Vacuum and pressure is
applied for some time.
The container is removed from the dye bath and washed. The
container is then inspected for the presence of dye either visually or
by means of UV spectroscopy. The dye used may be of blue, green,
yellowish-green color. The dye test can be optimized by use of a
surfactant and or a low viscosity fluid in the dye solution to increase
the capillary migration through the pores. The dye test is widely
accepted in industry and is approved in drug use. The test is
inexpensive and is requires no special equipment required for visual
dye detection. However, the test is qualitative, destructive and slow.
The test is used for ampoules and vials.
 Clarity test
Clarity testing is carried out to check the particulate matter in the
sample. In this test transparent particles or white particles observed
against the black background and the black or dark particles
observed against the white background.

Pyrogen test
There are tests performed to detect the presence of pyrogens in sterile
parenteral products.
 Rabbit test
 Bacterial endotoxin test (LAL test)

Sterility test
Sterility can be defined as the freedom from the presence of viable
microorganisms. Two methods are used to perform sterility test:
1. Direct transfer method.
2. Membrane filtration method

It is done for detecting the

presence of viable forms of
bacteria, fungi and yeast in
It is done for detecting the
presence of viable forms of
bacteria, fungi and yeast in

THE END