MY INTERNSHIP AT TROIKAA

PHARMACEUTICALS LTD.
-by Aryaman Shodhan
A Brief Introduction
Troikaa pharmaceuticals ltd. is a private
limited company that was founded by Mr.
Milan Patel in 1983. The company
produces and sells pharmaceuticals
ranging from tablets to injections
(parenteral) to ointments. The company
has 3 plants in Thol, Virochanagar
(Sanand) and Dehra Dun.

My Experience
I was with the organization from
20/3/2017 to 31/3/2017. I spent a week
at the Thol plant and 2 more days at the
Sanand plant. During this time I
observed and identified all the different
tasks carried out by each of the
departments present there- HR,
Production Planning, The warehouse,
Tablet, Parenteral, Ointment, spray and
liquid production, Quality Assurance,
Quality Control and Formulation &
Development and The Administration
Department. And most importantly, I
learnt how hard it was for the employees
at the factory to wake up at 6:30 in the
morning and work all the way till 5 in the
evening. However, this experience was
truly spectacular and in the end, I got to
learn a lot, meeting new people,
spending time at somewhere completely
different and eating food without my
family at the table! I now have a much
better idea as to how a typical private
limited company operates and how
street smart one needs to be to become
an entrepreneur of a company worth 600
crores! Watching the sheer dedication of
the workforce towards the company was
the best part of it all. Although I did not
do any legitimate “work”, I enjoyed
watching!

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Human Resource (HR)
The HR department is responsible for
the hiring and firing of workers, training
and the identification of workers needed
for overtime work. The HR department
also conducts medical tests on the
workers to ensure the drugs don’t get
contaminated if the workers are ill.
The recruitment process used is as
follows:
ž Job analysis
ž Job description
ž Job specification (a document
outlining the expertise needed for a
new job)
ž Advertising
ž Short Listing
ž Interview and selection
ž Rejecting unsuccessful employees.
The company uses induction training
and on the job training to make the
workforce more productive. The HR
department also pays the workers their
wages and calculates overtime
payments for workers.
Production Planning (PPMC)
This department is responsible for
planning the amount of raw material
needed to make a particular drug via
contact with suppliers and experience. It
also deals with packaging (marketing)
and monitors inventory levels of raw
material and packing material.
Organizing the week in which production
will be carried out is another one of the
functions of this very important
department. This is done via a product
prioritization sheet
The Warehouse
This is the store for raw material and
packaging material which are bought in
from vendors. Material is cleaned and
conditioned to remove dust. Secondary
cleaning is conducted using a duster.
Material is checked for invoice number
and damage. If both criteria are satisfied,
the box of material is labeled with a blue
Quarantine label. A part of the raw
material is sent to QC department for
analysis. The box is then labeled with a
yellow Under test label. If test results
turn out to be positive, the box is given a
green approved label; if negative, the
box is given a red rejected label.
Approved material is then used for
production; rejected material is sent to
the “rejectory” and destroyed. Raw
material is stored in their respective
areas; liquids and solvents stored
separately in another room, material to
be stored in 2oC to 8oC stored separately
in freezers to provide these conditions.
Packing material stored separately,
classified on the basis of type:
ž Primary packaging- Glass vials,
bottles, ampoules
ž Secondary packaging- Cartons,
labels
Tablet Manufacture
ž Dispensing
Raw material is weighed out exactly
depending on the number of tablets to
be made. The weight is re-echecked by
a QA executive. This process is carried
out in presence of a sodium light in order
to minimize contamination by ultra-violet
radiation.
ž Granulation
The raw material is passed through a 0.3
micron sieve to remove bacteria and
dust particles and to break down lumps.
The “filtrate” is then passed into a mixer
where bonding material like PVK-30,
HPMC, etc. to make a viscous paste.
The paste is then dried and sieved again
to break down lumps after mixing.
ž Compression
The mixture is passed into moulds (dice)
in the compressing machine. Under high
pressure, the mixture takes the shape of
the dice it is put in.
ž Evaluation
Tablets are checked for the following
properties:
Ø Mass: using a digital balance
Ø Thickness: using Vernier Callipers
Ø Friability: using a device with a
rotating wheel. The wheel moves 100
times and the loss of dry mass of the
tablets is checked. Total loss in dry
mass must be less than 1%.
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Ø Dispersion: using a dispersion
machine where water is added to the
tablets while in a sieve. The tablets
are soluble in water. The entire
mixture must pass through the sieve
within a time period depending on
the solubility.
ž Inspection
The tablets are checked to see if they
have any visible contamination or
damage.
ž Coating
Any tablet that must be coated is sent to
this part of the department. They are
placed into or sprayed with coating
solution. The purpose of coating is
simply to improve appearance and to
help the patient avoid the extremely
bitter taste of the tablets in the capsule.
ž Packing (Primary)
There are 4 ways in which a tablet is
packed:
Ø Blister packing where the tablet is
placed inside PVC depressions and
then sealed
Ø Alu-Alu packing where the tablet is
placed inside aluminium depressions
and then sealed
Ø Strip packing where tablets are put
into aluminium “pockets” which are
then sealed
Ø Pouch packing where powder is
added into aluminium pouches which
are then sealed
ž Packing (Secondary)
The leaves are put into their respective
cartons and are sent for dispatch.
Parenteral Manufacture
ž Unloading
The required number of vials and
ampoules are requested from the store.
Raw material is also ordered which is
directly sent to the production area.
ž Washing
Vials and ampoules are washed thrice
under sterile air conditions- twice under
mineral water and once under distilled
water. Containers and tanks are cleaned
as well.
Ø Glassware is passed through hot, dry
air to remove water
Ø Everything else is passed through
steam for cleaning
ž Filling
Distilled water, to be used as the solvent,
is sent to the Quality control department
to check for pH/presence of
contamination. The raw material is
dissolved in the distilled water and the
injection solution is checked for
contamination by the Quality Control
department as well. Nitrogen is flushed
before and after filling to remove dust
and air which may reduce the shelf life of
the injection. The vials and ampoules are
filled, two at a time with injection
solution.
ž Verification
Vials and ampoules are checked visually
and using machines to check for
contamination and the presence of
solution as well as for any cracks.
ž Sealing (ampoules)
Ampoules consist of a point where they
are broken. This is the point where 2
glass pieces are attached by melting the
glass at the junction of the pieces in
presence of a flame, sealing the injection
solution in the ampoule. The ampoules
are finally labeled, placed into cartons
and sent for dispatch.
ž Verification
The solution in the ampoules and vials is
checked against a white and black
background to identify any black or white
coloured impurity respectively.
ž Sealing (vials)
The filled vials are fitted with rubber
stoppers and seals. Labels are also
applied which show the manufacture and
expiry date before the vials are put into
cartons and sent for dispatch.
Ointment Manufacture
ž Dispensing
Raw material is weighed out exactly
depending on the number of tubes to be
made. The weight is re-checked by a QA
executive.
ž Bulk formation
Raw material, water and wax from the
waterphase and waxphase machines
respectively are emptied into the OMV
(Ointment manufacturing vessel). The
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bulk in the OMV is churned and mixed
for an hour to 2 hours depending on the
product to obtain a gel-like consistency.
ž Storage
The bulk is stored in the quarantine area
in a bulk storage tank.
ž Filling, packing and sealing
The entire process of packing, filling and
sealing is machine operated. Tubes are
filled with the bulk after they are made
free of dust using a vacuum. The plastic
is heated and sealed by pressing the
end together so it seals after cooling.
The excess part of the tube is cut and a
batch number is printed. The eye mark
(a black mark on the tube to indicate
when the cut must be made) is scanned
and the tube is sealed in a way such that
the eye mark is in the front. The machine
senses the eye mark through the aid of a
sensor and the cutter cuts at that
moment. The tube is placed into cartons
and its instruction sheet is also folded
and put into the box (this process is
machine operated as well). The tubes
are finally sent for dispatch.
Eye
mark Quality Assurance (QA)
Spray & Liquid Manufacture
ž Dispensing
Raw material is weighed out exactly
depending on the number of
sprays/bottles to be made. The weight is
re-checked by a QA executive.
ž Liquid manufacture
Raw material is mixed with water in a
machine operated manufacturing tank
through pipes and valves which are
machine operated as well.
ž Filling
Each vial is flushed with nitrogen to
remove air and dust before and after
filling. 8 vials filled at a time with the
liquid
⇒ For sprays,
Each vial passes through 3 stations:
Ø The vial is held in place at station 1
Ø The vial is sealed at station 2
Ø The spray ring (also known as the
actuator) and pump is fitted at station
3
⇒ For liquids, which includes
anesthesia liquid,
After filling, the bottle is sealed directly,
bypassing all the other stations the spray
bottles go through.
ž Labelling
After the process, a label is applied to
the bottle which depicts:
Ø Name of the product
Ø Batch number
Ø Manufacture and expiry date
Ø Chemicals used
Ø Packing
Each bottle is put into its respective
carton and sent for dispatch.
The Quality Assurance department is the
most important department in the entire
factory. It overviews the activities of the
entire organization. It coordinates and
collaborates with all the departments like
production and QC to ensure that no
error is made while their work is carried
out. It involves using GMP- Good
Manufacturing Practices- and GLP-
Good Laboratory Practices- to ensure
production of the best quality drugs. This
involves following documents called
SOPs to the point. SOP* stands for
Standard Operating Procedure and lays
down a systematic procedure for each
process in the factory. QA holds the
master copy for each SOP in each
department of the whole organization. A
controlled copy is given to each
department. There is a master copy
stamp on each SOP for security
purposes. The belief of the department is
“Cost of Quality”. This means that in
case there is any problem with a product
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in terms of quality, the best way to
minimize costs is by avoiding/preventing
occurrence of the problem altogether.
However, if any problem does occur,
inspection of the problem will cost 10
times more than prevention. Failure
correction will cost 100 times more than
prevention. Ratio of
Prevention:Inspection:Correction is,
therefore, 1:10:100.
ž Validation
Rigorous sampling which involves taking
more readings during analysis. It
demonstrates process control and
consistency. This means products must
be consistent in size and dosage.
Each product must fulfill criteria of
SISPQ- Strength, Identity, Safety, Purity
and Quality
ž There is also a Quality management
system which involves the following
sections:
Ø Change control: It is a form issued
for any change to be made within an
organization, for eg. to change the
procedure in an SOP.
Ø Deviation: It is a form issued when
someone must go against the
procedure laid down in the SOP.
Ø Market recall and complaint: Involves
withdrawal of the product should
there be any fault with it. It must be
done extremely quickly because it
involves the patient’s life which may
worsen if the flawed drug is
consumed.
Ø Investigation and root cause analysis
to find out the cause of a problem
with the product.
Ø Carrying out APQR- Annual Product
Quality Review to check if SISQP
criteria are met and there is no other
error.
ž IPQA- In Process Quality Assurance:
These are the checks and analysis
QA must carry out during the
production of the drugs:
⇒ Tablet
Ø Percentage loss of mass on drying
Ø Tablet Weight
Ø Disintegration Time
Ø Friability
Ø Dispensing
Ø Coating: Weight gained on coating
⇒ Parenteral
Ø Checking clarity of pure water
Ø Presence of chloride ions in pure
water
Ø pH of injection solution and pure
water
Ø Particulate matter check
Ø Checking Nitrogen Flushing
Ø Checking sealing height of ampoules
⇒ Liquid inhalation (Anesthesia)
Ø Appearance of bottles
Ø Integrity of seal of filled bottle
Ø Room temperature in production
⇒ Packing
Ø Leak test
Ø Completeness of packs
Quality Control (QC)
This department conducts laboratory
tests on raw and packing material as
well as the finished product. If the
material satisfies the criteria, only then
will it be used for production. Listed here
are some of the tests carried out on each
of these materials, although there are
several others!
ž Packing material
⇒ Secondary
Ø Length, width and height of the
carton
Ø Colour and type of box
Ø Slit test (If the slits allow the carton to
be folded)
⇒ Vials
Ø Colour, shape and size of vial
Ø Type and colour of seal
Ø Type and size of paper used for
insert
⇒ Ampoule
Ø Type and size of glass
Ø Size of label
Ø Type and size of paper used for
insert
⇒ Blister foil, strip foil
Ø Colour and size of foil
Ø Type and size of paper used for
insert
ž Micro biology
This section is part of the QC
department. This section is responsible
for the testing of drugs on micro-
organisms. The micro-organisms are
grown or “incubated” under suitable
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conditions. Some must be kept at 35oC
to 40oC and are hence kept in ovens.
Then the culture is tested using drugs to
identify the bacteria’s weakness against
the drug. The culture is then autoclaved
by cleaning the glassware and
destroying the bacteria to help reduce
chances of disease.
ž Chromatography
This is the most important process in QC
because it helps to identify the purity of
sample of drugs. Chromatography
involves the substances being separated
on paper on the basis of their solubility in
a particular solvent. The components
can be identified then by measuring their
distance travelled and the number of
components in the sample can help
determine if it is pure or not. The
machine in the department produces a
graph with a series of peaks and stable
regions. Each peak represents one
substance. The internal pressure is also
kept under control.
ž Documentation
This section of the department is
responsible for printing worksheets
which contains the tests to be carried out
on each drug. The QC executives fill out
the worksheet as they carry out the
tests. Worksheets are made for raw
material, packing material and the
finished product.
Formulation & Development
(F&D)
This department is responsible for the
development and testing of new drugs
and a new brand of an existing drug from
a competitor’s brand.
ž For an existing product:
A product sample from a competitive
brand is analysed by this department
and certain characteristics are taken into
account. pH and water content is taken
into account for injections whereas
weight, thickness and colour is taken into
account for tablets. Then market
research is carried out to know what
consumers want. Based on market
research results and experience, a
compatibility study and generic formula
is produced. The generic formula
contains the same dosage and form of a
particular drug. It means, a product that
needs to be in tablet form must be in
that particular form. The amount of drug
the patient needs must also be the same
as the competitor’s brand. Suitable raw
materials are ordered form the supplier.
A stability study is created which helps to
identify a product’s shelf life. Here, a
product is kept under stress conditions
(unsuitable conditions) and the shelf life
is observed.
ž For a new product,
Based on literature searches, experience
and trial and error methods, the product
is produced.
ž Testing (Tablets)
The drug is dissolved in a quick
penetrating solution to check for
solubility. It is then tested to see if
crystals reappear when the solution is
placed at different temperatures. If
crystals reappear, the product is likely to
have a short shelf life. The tablet is also
checked for thickness, hardness,
friability and dispersion.
ž Testing (Injections)
Injections are tested for:
Ø pH
Ø Contamination
The prepared solution is filtered to
remove dust and autoclave is carried out
to remove microbes.
The Administration Department
This department contains all the utilities
needed for the smooth functioning of the
factory and to ensure production of good
quality drugs.
ž These include:
Ø The Boiler Room: Heating water and
supplying hot water to the factory.
Ø Cooler: For provision of cool water to
cool machinery.
Ø Ozone tank: To remove microbes
and supply pure water for production
purposes.
Ø Diesel tank: Stores diesel and
provides power during power cuts by
the government.
Ø Electric and diesel pumps to pump
water in order to control a fire.
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Ø Water pump: Pumping water from
the ground in order to supply to the
factory.
Ø Sewage treatment plant: To remove
toxic wastes from the used water
from the plant before disposal into
canal.
Ø Nitrogen tank: to provide high
pressure nitrogen gas to the factory
which is used in production in the
process of “nitrogen flushing”.