IPQC stands for in process quality control.

These are checks that are carried out before the

manufacturing process is completed. The function or purpose of in-process controls is monitoring
and if necessary adaption of the manufacturing process in order to comply with the specifications.
This in process check is to be carried out at different stages such as drying, blending, compression,
coating, blistering, filling, labelling, and packing. 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. All the IPQC including those in production area and personnel should
be performed by QC staff according to the method approved by the Quality Control and the result
will recorded.

1. Appearance

During drying and blending process, it is importance for IPQC team to monitor the mixture
appearance so that substance is comply with the specification. Example of the control of general
appearance may involve the colour, size and also odour of the substances.

Also, during tablet compression, the tablet will be observed for their logo, shape, colour, diameter
surface and textures in order to ensure the tablets follow the specifications. IPQC will take some
sample and check whether the tablet:

 Wrong tablet ID (wrong logo one or both sides)

 chipping/emboss defect
 Mottling tablet (black/red/brown spot)
 Capping/laminating tablet/major rugged edges
 Sticking/twinning tablet
 Embedded particle
 slight powdery tablet/ minor rugged edges

Besides, during coating process also, the IPQC will monitor the appearance of each lot where they
will be more focus on the coating colour, diameter and also physical surfaces of the tablets whether
the coating is uneven, cracking, capping, chipping or having an emboss defect or not. Examples of
the criteria of defect that are taken into account include:

 Chipping/emboss defect
 Mottling tablet (black/red/brown spot)
 Capping/laminating tablet/major rugged edges
 Sticking/twinning tablet
 Embedded particle
 Contaminated tablet
 Film-coating cracking
 Bridging and filling tablet
 Uneven colour tablet
 Powdery tablet
 Tiny embedded spot
The importance of this tablet appearance testing is essential for control of lot-to-lot uniformity and
also tablet-to-tablet uniformity and consistency. Besides, it is also important to ensure customer
acceptance towards the tablet.

2. Moisture/water content

Moisture content test is where we test the amount of moisture/water content present in the
granule. For this test, IPQC will collect the sample of dried powder (after drying process) and check
whether it comply with the specification or not. If the moisture content is out of specification (too
dry or too moist) it may affect the whole process and influence the tablet formulation. Besides, it is
important to keep the moisture within the allowable limit in order to prevent product deterioration
and also to ensure free flowing properties and compressibility of the powder. The moisture content
test is carried out using moisture analyser whereas water content test is done using Karl Fischer
titrators.

3. Hardness test

Hardness test is where a load or force required to crush the tablet when placed on its edge. This test
is used to evaluate the breaking point and structural integrity of the tablet produced when it is
under conditions of storage, transportation, shipping, and dispensing. The instrument that is widely
used to test tablet hardness is Dr. Schleuniger Pharmatron Tester. The importance of this tablet
hardness testing is to determine the ability to withstand the shock of handling, packing and shipping
of the tablets and it is also important physical parameter as it is related to tablet disintegration. For
example, if the tablet is too hard, it may not disintegrate within the required period of time. And if
the tablet is too soft, it may not withstand the handling during subsequent process such as coating
or packaging.

4. Diameter
The diameter of a tablet is determined by the die and punches used in tablet compression process.
IPQC will collect 10 tablets randomly and measure each tablet’s diameter. The instrument used to
determine the diameter is using a calliper. The importance of this test is to ensure the consistency of
the appearance of the tablets produced for each lot.

5. Disintegration

Disintegration is a process in which tablets are break up into granules or smaller particles. The
disintegration apparatus consists of a basket rack holding six plastic tubes, open at the top and
bottom. The bottom of the tubes is covered with 10-mesh screen. This basket rack will be immersed
in a bath of suitable liquid, held at 37 degree Celsius, preferably in a 1-L beaker. The rack moves up
and down in the fluid at a specified rate. One tablet will be placed in each plastic tubes and the time
it takes to disintegrate is measured. The purpose of this disintegration test is to determine and
measure the time required for the tablets to break up into particles under a given set of conditions.
Besides, the availability of a drug from the tablet depends on its ability to disintegrate fast enough in
the existing dissolution media (this is because rate of drug dissolution is greatly influenced by
disintegration of the tablet).
 6. Friability
The measurement of friability is made by Roche friabilator where a number of tablets are weighed
and placed in the tumbling apparatus where they are exposed to rolling and operated shocks
resulting from free falls within the apparatus. After a given number of rotations, the tablets are
weighed and the loss in weight indicates the ability of the tablets to withstand this type of wear. This
friability testing is used in order to test the durability of the tablets during coating, packaging, and
shipping.

7. Tablet thickness

Tablet thickness is important for tablet packaging. A very thick tablet will affect the packaging either
in blisters or plastic containers. The tablet thickness is determined by the diameter of the die, the
amount of fill permitted to enter die and the force or pressure applied during compression.

8. Average weight

For average weight test, 20 tablets of each lot will be taken by IPQC. These 20 tablets will be
weighed and the average will be calculated. This test will help to ensure that the tablet contain the
proper amount of drug.

9. Uniformity of weight

To determine the uniformity of weight, 20 tablets will be taken from each lot. Then, the tablets will
be weighed individually. This uniformity of weight is an in process test which ensures consistency of
dose during compression. Inconsistent powder or granulate density and particle size distribution are
common sources of non-uniformity during compression.

10. Visual inspection (packaging)

For packaging, inspection will be carried out once the items arrived in the warehouse. Not all items
will be inspect by QC as they will follow the acceptance quality limit. For example, if the batch size of
the items is around 151-280, only 32 sample size will be taken. If the batch size is more than 280 and
less than 500, only 50 sample size will be used. These sample size will be inspect if there is any
defect such as long/short burr on the eco bottle, crack/bubble at the amber glass bottle and etc.

If any defect is found during the on-going process, IPQC will refer to production, QA, QC, QM
manager immediately in order to update the status prior to stop the process and rectify the
problem.