1.

Appearance
2. Moisture content
3. Average Weight
4. Uniformity of weight
5. Hardness
6. Thickness
7. Diameter
8. Disintegration
9. Friability
10. Visual inspection

In- process quality control

Purpose: to ensure and maintain uniformity and intergrity of drug product. Inspection of raw
material, equipment, environment, process, testing with respect to specification, and packing.

a. At manufacturing operation stage

b. At sampling stage
c. In-process test
d. At Packing stage

1. Tablet appearance (Compression, Coating)

The general appearance of a tablet is essential for consumer acceptance, for control of lot-
to-lot uniformity and tablet-to-tablet uniformity. The control of general appearance involves
logo, shape, colour, surface, textures physical flaws and consistency.

IPQC will inspect the appearance of the tablet based on their specifications. For example,

a. Oralmet
Oralmet 500mg tablet (uncoated)- white, 12mm diameter, round convex tablet with “SL”
logo on one side and breakline on the other.
Oralmet 500mg tablet (coated)- white, round convex, film-coated tablet, 12mm diameter,
inscribed with “SL” logo on one side and breakline on the other side.

Oralmet 850mg tablet (uncoated)- white to off-white, convex, 14mm diameter tablet with
“SL logo on one side and plain on the other)
Oralmet 850mg tablet (coated)- off-white to slightly yellow, convex, 14mm diameter, film-
coated tablet, inscribed with “SL” logo on one side and plain on the other

Oralmet 1000mg tablet (uncoated)- white to off-white tablet, capsule shaped 10mm x
18.75mm with breakline on one side and “SL 1G” logo on the other side.
Oralmet 1000mg tablet (coated)- off-white to slightly yellow, film-coated tablet, capsule
shaped 10 x18.75mm with breakline on one side and “SL 1G” logo on the other side
 b. Paralgin forte

White, round convex, 12 mm diameter tablet, inscribed with “SL” logo on one side
and breakline on the other.

c. Paralgin

White, round convex, 12 mm diameter tablet, inscribed with “SL” logo on one side and
breakline on the other.

Tablets are considered defect if:

A. CORE TABLETS
i. Critical: Wrong tablet ID (wrong logo one or both sides)
ii. Major: - chipping/emboss defect
- Mottling tablet (black/red/brown spot)
- Capping/laminating tablet/major rugged edges
- Sticking/twinning tablet
- Embedded particle
iii. Minor: - slight powdery tablet/ minor rugged edges
B. COATING TABLETS
i. Major :
- 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
ii. Minor: - tiny embedded spot

2. Moisture content (drying, blending)

Moisture content is the amount of moisture present in the granule. Moisture is required for the
binding of the powder or granules during compression in the die cavity. Percentage of moisture is
calculated by using ‘moisture balance’ or ‘IR Balance’. Each product has their own specification for
moisture content. To determine the moisture content, IPQC will collect the sample of dried powder
after complete drying.

Specification for most product – 0.5-1.0%

 3. Average Weight

4. Uniformity of weight

Uniformity of weight is an in process test parameter which ensures consistency of dosage

units during compression. It is carried out during tablet compression and coating process. *

5. Hardness

It is 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 solubility.

Example:

a. Paralgin tablet- 60-110N

b. Paralgin Forte tablet: 50-100N
c. Oralmet 500mg: Not less than 70N
d. Oralmet 850mg: More than or equal to 60N
e. Oralmet 1000mg: 100-150N

6. Tablet Thickness

The thickness of the tablet from production-run to production run is controlled carefully.
Tablet thickness can vary with no change in weight due to the difference in the density of the
granulation, the pressure applied to the tablets and also the speed of the tablet compression.

Instruments used include ______*

7. Diameter

It is determined by the die and punches used in compression. Importance of this test is to
ensure the consistency of the appearance of the tablets produced.

8. Disintegration
Disintegration is a process in which tablets are break up into granules or smaller particles.
The time it takes a tablet to disintegrate is measured in a device described in the USP/NF.

So, disintegration test is a measure of the time required for a group of tablets to break up into
particles under a given set of conditions.

9. 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.

10. Visual inspection (blistering)

Packing material such as blister will be inspect by IPQC. IPQC will check for any defect of the blisters
according to the criteria:

i. Major : - Deformed pocket

- Deep cut on blister
- Deep cut on embossing
- Slitting/pinhole aluminium foil
- Weak seal/crumple
- Embossing batch invisible
- Missing alphabet/number
- Incorrect printing colour

ii. Minor : - Embossing batch not clear & visible

- Blister surface dusty or dirty
- Inconsistent printing colour

If there is any defect found while process is going on, IPQC will inform QA/QC manager for status
prior to stop the process and rectify the problem.