In-process controls (IPC) are checks that are carried out before the manufacturing process is

completed. The function of in-process controls is monitoring and if necessary adaptation of

the manufacturing process in order to comply with the specifications. This may include control
of equipment and environment, too. In-process materials should be tested for identity, strength,
quality and purity as appropriate and approved or rejected by the Quality Control unit during the
production process. Rejected in-process materials should be identified and controlled
under a quarantine system designed to prevent their use in manufacturing. Written procedures
should be established and followed that describe the In-process controls and tests as specified:
Tablet or capsule weight variation,
Disintegration time,
Content uniformity and homogeneity,
Dissolution time and rate,
Clarity, completeness or pH of solutions.
In-process controls may be performed in regular intervals during a process step
(e.g. tabletting, encapsulation) or at the end of a process step (e.g. granulation,
blending).
Physic evaluation
Hardness test
Hardness can be defined as the strength of the tablet to withstand the pressure applied. The tablet
to be tested was held between a fixed and a moving jaw of Monsanto Hardness Tester. The force
applied to the edge of the tablet was gradually increased by moving the screw knob forward until
the tablet breaks. The reading was noted from the scale which indicates the pressure required to
break the tablet. The hardness of a tablet depends on the weight of the material used, space
between the upper and lower punches at the time of compression and pressure applied during
compression. The hardness also depends on the nature and quantity of recipients used during
formulation. If the finished tablet is too hard, it may not disintegrate in the required period of
time and if the tablet is too soft it may not withstand the handing during packing and
transporting9.
Friability test
Friability test can be performed to evaluate the ability of the tablets to withstand abrasion in
packing, handling and transporting. The Friabulator consists of a plastic chamber divided into
two parts and revolves at 25 rpm. A fixed number of tablets are weighed, placed in the tumbling
chamber and rotated for four minutes of 100 revolutions. During each revolution the tablets fall
from a distance of six inches to undergo shock. After 100 revolutions the tablets are again
weighed. The loss in weight indicates the friability. The acceptable limits of weight loss should
not be more than 0.8% t. The friability (f) is given by: f = 100 (1-wo/w), where, wo = initial
weight of the sample before friability and w = weight of the samples after friability test10.
Dissolution test
Stated volume of the dissolution medium, free from dissolved air was introduced into the vessel
of the apparatus. The dissolution medium was warmed between 36.5o and 37.5o. The tablet was
allowed to sink to the bottom of the vessel prior to the rotation of the paddle. Wire helix was
used to keep the tablet horizontal to avoid floating at the bottom of the vessel. Air bubbles were
removed from the surface of the tablet. A sample from the surface of the dissolution medium was
withdrawn, analysed for absorbance as directed in the standard monograph using

spectrophotometer. The whole operation was repeated for five times and the amount of dissolved
active ingredient of the tablet in the solution as a percentage of the stated amount was
calculated11.
Weight variation:
Take 20 tablets and weigh them individually, then calculate average tablet weight, and
percentage deviation for each tablet:
Average tablet weight

Percentage deviation

130 mg or less

10

131-324 mg

7.5

325 mg

Accepted tablet:
Not more than two tablets are outside the percentage limit and no tablet differ by more than
two times the percentage limit according to the above table.
Suspected tablet:
Not more than six tablets are out side the percentage limit and no tablet differ by more than
two times the percentage limit according to the table.
Rejected tablets:
One tablet differs by more than two times the percentage limit according to the table.
More than six tablets are outside the percentage limit.
Tablet Disintegration: It can be defined as the break down of tablets into smaller particles as
it contacts with water.
For uncoated tablets and plain coated tablets:
Place 1 tablet in each of the six tubes of the basket and operate the apparatus, using water
maintained at 37-+ 2 0C as the immersion fluid unless otherwise specified in the individual
monograph. At the end of time specified in the monograph, all the 6 tablets have disintegrated
completely. If 1 or 2 tablets fail to disintegrate completely, repeat the test on 12 additional
tablets, not less than 16 of 18 disintegrate completely. 3- Content uniformity of the dosage
units
a. Weight determination:
Done on uncoated tablet and film coated tablet, select not fewer than 30 units, take 10
units, weight accurately 10 tablets individually. Calculate the average tablet weight. Crush
each tablet and apply the assay procedure in each monograph, calculate the content of
active ingredient. Calculate the average content of active ingredient, assuming
homogeneous distribution of the active ingredient.

b. Content uniformity: select not fewer than 30 units; assay 10 units individually as directed
in the assay in the individual monograph. Where a special procedure for content
uniformity is specified in the test for uniformity of dosage units in the individual
monograph, assay separate A, assay and calculate the weight of active ingredient
equivalent to one average dosage unit. P, using the special procedure for content
uniformity in the monograph, calculates the weight of active ingredient equivalent to one
average dosage obtained by the special procedure. If 100 *(A-P/A) is greater than 10, the
use of correction factor is not valid. Calculate F value, F=A/P, a valid correction if F value
is between 1.030-1.100 or between 0.900-0.970, calculate the weight of active ingredient
in each dosage unit by multiplying each of the weights found using the special procedure
by F.