KAILASH INSTITUTE OF PHARMACY AND

MANAGEMENT
(GIDA GORAKHPUR)

PROJECT ON
INDUSTRIAL TRAINING 1st
SESSION - 2022-23
SUBMITTED BY –
YUKTISHA DWIVEDI
B. PHARM - 3rd year/6th SEMESTER
ROLL NO. - 2005160500111
AFFILIATED TO-

DR. A.P.J. ABDUL KALAM TECHNICAL UNIVERSITY

LUCKNOW (UTTAR PRADESH)
 DR. A. P. J. ABDUL KALAM TECHNICAL UNIVERSITY,

LUCKNOW

Declaration by the Candidate

I hereby declare that this Project entitled INDUSTRIAL TRAINING 1st is a

Bonafide and genuine report carried out by me under the guidance of Dr. JAI
NARAYAN MISHRA (Director of Pharmacy) of Kailash Institute of Pharmacy and
Management GIDA, Gorakhpur.

Date:

Place: STUDENT NAME

YUKTISHA DWIVEDI
ROLL NO. 20051605000111
B. Pharm 3rd year
 KAILASH INSTITUTE OF PHARMACY AND MANAGEMENT
GIDA GORAKHPUR

Certificate by the Supervisor

This is to certify that the Project entitled INDUSTRIAL TRAINING 1st is a

Bonafide report done by in the degree YUKTISHA DWIVEDI of Bachelor of Pharmacy.

Date: Dr. JAI NARAYAN MISHRA

(DIRECTOR OF PHARMACY)
Place: Kailash Institute of Pharmacy and Management
GIDA Gorakhpur
 ENDORSEMENT BY THE DIRECTOR/ HEAD OF THE
INSTITUTION

This is to certify that the Project entitled INDUSTRIAL TRAINING 1st is a

Bonafide research work done by YUKTISHA DWIVEDI under the guidance of Dr.
JAI NARAYAN MISHRA (DIRECTOR OF PHARMACY) Kailash Institute of
Pharmacy and Management, GIDA Gorakhpur.

Date: Dr. JAI NARAYAN MISHRA

(Director Of Pharmacy)
Place: Kailash Institute of Pharmacy and Management
GIDA Gorakhpur
 Kailash Institute of Pharmacy and Management,
GIDA Gorakhpur

AKNOWLEDGEMENT

It is matter to great rejoices to prepare a project on “INDUSTRIAL TRAINING-I”

This project made as per AKTU syllabus.

I wish to express my sincere and special thanks to MAA SARASWATI &

LORD BUDDHA with who bless to complete my project.
It makes me privilege to do work under inspiring guidance MR. DHANESHWAR
KUMAR VISHWARKARMA (HOD) MR. AMIT KUMAR SHUKLA (Associate
prof.) RATNAKAR SINGH (Assistant prof.) & MR. ABHAY PRATAP SINGH
(Associate prof.) His knowledge obviously provided me to get moving focus that
enables my vigor and ability to complete my project. I am highly grateful to
him for his kind and valuable guidance, supervision, inspiration, cooperation
and providing requiresuggestion.
I wish to express my sincere thanks to the Chairman, MR. R.D. SINGH
Sir and MR. VINOD KUMAR SINGH Sir (Managing Director).
I wish to express my sincere and special thanks to the Director of Pharmacy,
Dr. JAI NARAYAN MISHRA Sir who provides the entire requirement
regarding my project.
I wish to express my sincere thanks KUSUM HEALTHCARE PVT. LTD.
and MR. SANJEEV GUPTA for his great guideline in Industry for my
knowledge.
Thanking Again.

YUKTISHA DWIVEDI
Roll no.- 2005160500111
B. Pharm 3rd Year
1
 COMPANY PROFILE

KUSUM HEALTHCARE PRIVATE LIMITED

Started in 1997, kusum Health care Pvt.Ltd

is an export Oriented pharmaceutical
company headquartered in New Delhi. The
company started production by setting up
its first formulation plant in 2007, Bhiwadi
Rajasthan followed by another Fully
automated production plant in Indore,
Madhya Pradesh in 2018 managing
production in India

Kusum Health care private limited has been

under Leadership of Mr.B.P Gupta, Director
founder of kusum Heath care and reputed leader
in the Indian pharmaceutical Industry under the
leadership of Dr. T G chandrashekhar Executive
director.Young efficient and tech driven, kusum
is a Pharmaceutical Group of companies
headquartered in Delhi, India hasIt's own state of
art manufacturing and R&D facilities Spread
globally.4pharmaceutical drug manufacturing
sites, 3 in India (Bhiwadi and SEZ pithampur and

05
 1 in Ukraine (sumy) are equipped with modern
equipment For leading manufacturers of world.
With aim to manufacture high quality
affordable, efficient Safe process prescription
drugs and OTC medicine, for People world-
wide, a global team of highly self motivated
With modern High precision manufacturing
unit, with Proven world renowned suppliers of
raw material and Pharmaceutical components.
Kusum runs world chain pharmaceutical
manufacturing Plant's at bhiwadi Rajasthan
and pithampur Indore M.P The pharmaceutical
units and system are designed to meet And
Excel all International norms. it's ISO 9001
and ISO 4001 certified plants manufacturing
pharmaceutical Oral solid, Topical dosage
form, ointment, shampoo, wax Based
suppository.Pharmaceutical packaging
facilities are Available in the form of
blisters,cold forming blisters, Sachets, bottles,
tubes. Kusum pharmaceutical R&D facilities is
equipped with World class pharmaceutical
infrastructure with Industry Leading workforce,
develop various solid dosage form, Semi solid
dosage, liquid dosage forms.

05
05
 Who We Are

We are a young, efficient, and tech-driven

pharmaceutical group with its own state-of-the-
art manufacturing and R&D facilities
globally augmented by a robust distribution
network. We have 4 manufacturing sites,
3 in India (Bhiwadi and SEZ Pithampur) and
1 in Ukraine (Sumy), equipped with
modern equipment from the leading
manufacturers worldwide.

We aim to manufacture high quality, affordable,

efficient, and safe for people across the world.
All this is possible thanks to the work of
an international team of highly self-motivated,
qualified industry specialists, modern high-
precision manufacturing equipment, and
proven world-renowned suppliers of
raw materials and components.

05
 What We Do

We produce quality medicine & formulations

following stringent requirements of GMP
(Good Manufacturing Practice) that are
incorporated right from the production stage.
In addition,a team of highly qualified staff
constantly monitors all production procedures.
This gives us absolute confidence in the
quality of our products with strict control on
the manufacturing processes at ever stage .

In the past 5 years, our manufacturing facilities

have passed more than 60 government
& medical body audits worldwide.
We firmly believe that “Human life and health
is invaluable, and there can be no compromise.

05
 Our Mission & Vision

The Company is driven by its vision to

achieve significant business in proprietary
prescription products with a strong presence
in developed markets. Kusum Healthcare
Private Limited is poised for major
expansion through new products, covering
new market segments, expanding field force
in existing markets, and setting up operations
in more countries and continents.

Since its inception, Kusum Healthcare has

been working towards “Quality and Health for
all” and will continue to strive for the same.
A healthy lifestyle knows no age or boundaries.
At Kusum Healthcare, we dream of a world
free of suffering and physical pain. A world
that evokes smiles and prosperity in every
family.

05
05
 CONTENTS
Page no
1. Tablet section

Topic Page No.

Tablet
Ingredients used in tablet formulations
Granulation
Blending
Sieving
Dryer
Tablet punching
Tablet coating & type of coating
Some common problem in tabletting
U.P.D.P.L. Product list (Tablet)

2. Quality control

Topic Page No.

Quality Assurance & Quality Control in Pharma Industry
Quality Control work (Summary
Chemical section
Instrumental section
Micro-biological section

4. Packing section

Topic Page No.

Packaging & it’s type

The purposes of packaging and package labels

6
 LIST OF ABBREVIATIONS

CGMP = Current Good Manufacturing Process

D.M. Water = Demineralized Water.

EC = Ethyl cellulose

GIT = Gastrointestinal tract.

GMP = Good Manufacturing Process

HPMC = Hydroxy Propyl Methyl Cellulose.

HPC = Hydroxy Propyl cellulose

MHEC = Methyl Hydroxy Ethyl Cellulose.

PEG =Polyethylene Glycol.

SCMC = Sodium corboxy methyl cellulose

7
 TABLET SECTION


8
 TABLET MANUFACTURING
SECTION
Tablet Components and Additives

A. Active Ingredients: ornidazole IP, Folic acid, pantoprazole sodium, tranexamic acid,
azithromycin, cefixime, metformin, vitamin B6, etc.
B. Non-active Ingredients: six major excipient categories
a) Diluents: lactose, starch, mannitol, Sorbitol
b) Binders: Acacia, Gelatine, Tragacanth, starch.
c) Lubricants: stearic acid, magnesium stearate, calcium stearate. and talc
d) Disintegrants: Starches are the most common disintegrating agents
e) Colours: D&C and FD&C dyes and lakes,
f) Flavours and Sweeteners: mannitol, lactose, sucrose, saccharin and dextrose.

Unit Operations
There are three methods of preparing tablet granulations. Such as:
a) Wet granulation,
b) Dry granulation (also called "slugging"), and
c) Direct compression.

 Each of these methods has its advantages and disadvantages.

 Each individual operation of the process is known as a unit operation.

a) WET GRANULATION
1. Milling of drugs and excipients.
2. Mixing of milled powders.
3. Preparation of binder solution.
4. Mixing binder solution with powder mixture to form wet mass.
5. Coarse screening of wet mass using 6- to 12- mesh.
6. Drying moist granules.
7. Screening dry granules with lubricant and disintegrants. 8. Mixing screenedgranules with
lubricant and disintegrants.
8. Tablet compression.

b) DRY GRANULATION
1. Milling of drugs and excipients.
2. Mixing of milled powders.
3. Compression into large, hard tablets called slugs.
4. Screening of slugs.
5. Mixing with lubricant and disintegrating agent.
6. Tablet compression.
c) DIRECT COMPRESSION
1. Milling of drugs and excipients.
2. Mixing of ingredients.
3. Tablet compression.

9
 EQUIPMENTS

1. Sifter
An instrument used to sieve the ingredients of a tablet with a replaceable mess ware. Inthis technique,
particles of power mass are placed on a screen made of uniform aperture. The sifter is attached with
a vibrator that helps in sieving the materials through the meshwork. The mechanism of action is to
loosen the packing of the particle in contact with screen surface, permitting entrapped sub sieve
particles to the screen surface.

1. Planetary Mixer
For wet granulation a planetary mixer is used. Solutions of the binding agent are added to the mixed
powders with stirring. The powder mass is wetted with the binding solution until the mass has the
consistency of damp snow. The planetary mixer can mix a material of 100kg. The beater of the
planetary mixer revolves 2-4 times for each revolution of the head, providing double mixing action.

2. Mass Mixer
This is also mixing equipment used to mix dry as well is wet ingredients. The mixer has blades that are
alternately arranged and is allows uniform mixing. The mass mixer is emptied by inverting it and
scrapping off its ingredients. The planetary mixer can mix a material of 100kg.

3. Multi-mill
This is a hammer mill that uses a high-speed rotor to which a number of swinging hammers are fixed.
The unit is enclosed with chamber containing a grid or removable screen through which the
material can pass. The material is fed from the top and ground by impact of hammers or against the
plates around the periphery of the casing. The materials are enough pass through the screen that
forms the lower portion of the chamber. The fragments are swept downward against the screen
where they undergo additional hammering action until they are reduced to a size small enough to
pass through the openings and out. Oversize particles are hurled upwards into the chamber where
they also undergo further blows by the revolving hammers.

10
2. Fluidized bed dryer
In a fluidized bed dryer, the fluidized air stream is introduced by a fan or blower mounted at the top of
the apparatus. The air is heated to the required temperature in an air heater and flows upwards
through the wet materials, which remains in a drying chamber fitted with a wire mesh supported
at the bottom. By this process, the material is suspended and agitated in a warm air stream while
the granulation is maintained in motion.

3. Tray dryer

It consists of a chamber, containing horizontal arrangements of trays on which granules are dried.
The drying process is accomplished by a gust of hot air driven by or blower through an electric
heater and heat exchange. In this method, the wet materials are placed over paper sheets and
finally placed over the trays and the drying operation is carried out. These dryers are mainly
useful for materials that contain alcoholic solutions and where slow drying for better granule
characteristic is necessary.
4. Compressor
For increased production, Rotary machines offer a great advantage. A head carrying a number of
sets of punches and dies revolves continuously while the tablet granulation runs from the
hopper, through a feed frame and into the dies placed in a large, steel plate revolving under it.
This method promotes a uniform fill of the die and therefore an accurate weight for the tablet.
Compression takes place as the upper and the lower punches passes between a pair of rollers.
This action produces a slow squeezing effect on the material in the die cavity from the top and
bottom and so gives a chance for the entrapped air to escape. The punches and dies can be
removed for inspection, cleaning and inserting different sets to produce a great variety of
shapes and sizes.

TABLET PRESSES
 The basic unit of any tablet press is a set of tooling consisting of two punches and a diewhich is called
a station.
 The die determines the diameter or shape of the tablet; the punches, upper and lower, come together
in the die that contains the tablet formulation to form a tablet.
 There are two types of presses: single-punch and rotary punch.

11
  The single-punch press has a single station of one die and two punches, and is capable of producing
from 40 to 120 tablets per minute depending on the size of the tablet. It is largely used in the early
stages of tablet formulation development.
 The rotary press has a multiplicity of stations arranged on a rotating table in which the dies are fed the
formulation producing tablets at production rates of’ from a few to many thousands per minute.
 There are numerous models of presses manufactured by a number of companies, ranging in size,
speed, and capacity.
Tablet presses consist of
1) Hoppers, usually one or two, for storing and feeding the formulation to be pressed
2) Feed frame(s) for distributing the formulation to the dies
3) Dies for controlling the size and shape of the tablet
4) Punches for compacting the formulation into tablets
Cams (on rotary presses) that act as tracks to guide the moving punches. All other parts of the press are designed
to control the operation of the above parts

COATING
 Tablet coatings perform one or more of the following functions. They may: mask the taste of
unpalatable drugs, protect the drug from deterioration due to light, oxygen or moisture, separate
incompatible ingredients, control the release of medicament in the gastrointestinal tract, and provide
an elegant or distinctive finish to the tablet.
 The materials used for coating may largely comprise sucrose (sugar coating), water soluble film
forming polymers (film coating) or substances which are soluble in the intestinal secretions but not in
those of the stomach (enteric coating).
 These types of coating can all be applied by the pan or fluid-bed processes; the compression coating
technique is suitable for sugar and enteric coatings, but not for film coating.

TYPES OF COATING
1) SUGAR COATING
2) FILM COATING
3) MODIFIED RELEASE COATING






12
1) SUGAR COATING:

This traditional coating imparts a smooth, rounded, elegant appearance to the tablet. Stephenson
and Smith (1951) have given a detailed discussion on the composition of sugar coatings.
 The sugar-coating process involves building up layers of coating material on the tablet
cores as they are tumbled in a revolving pan by repetitively applying a coating solution or
suspension and drying off the solvent.
 Before sugar-coating, the core is coated with a sealing coat of shellac, PVP*-stabilized
types of shellac, or other polymeric materials, such as cellulose acetate phthalate and
polyvinyl acetate phthalate.
 The next stage is to build up a sub coat that will provide a good bridge between the main
coating and the sealed core, as well as round off any sharp corners. This step is followed
by smoothing or grossing.
 The finishing stage is accomplished by again applying one or two layers of clear syrup.
The tablets are then left for several hours before being transferred to the polishing pan.
 The polish is a dilute wax solution (e.g., carnauba or beeswax in petroleum spirit) applied
sparingly until a high lustre is produced.

2) FILM COATING:

Film coating has increased in popularity for various reasons.

 The film process is simpler and, therefore, easier to automate. It is also faster than sugar-
coating, since weight gains of only 2 to 6% are involved, as opposed to more than 50%
with sugar-coating.
 Two major groups of film coating materials may be distinguished:
o Those that are non-enteric and, for the most part, cellulose derivatives, and
o Those that can provide an enteric effect and are commonly esters of phthalic acid.
 Films may contain a plasticizer that prevents the film from becoming brittle with
consequent risk of chipping.
 Until recently, alcohols, esters, chlorinated hydrocarbons, and ketones have been among
the most frequently used types of solvents. However, because of increasing regulatory
pressures against undesirable solvents, there has been a pronounced trend toward aqueous
film coating.
3) Modified-Release Coatings:

A coating may be applied to a tablet to modify the release pattern of the active ingredient.
 Two general categories, enteric coating and controlled-release coating, are
distinguished.
 The former is insoluble in the low pH environment of the stomach but dissolve
readily in the small intestine with its elevated pH.
 They are used to minimize irritation of the gastric mucosa by certain drugsand to protect
others that are degraded by gastric juices.


13
PACKAGING AND LABELLING OF TABLETS
 Packaging and Labelling of tablets are done in Packaging and Labelling area.
 In this area concurrently three actions i.e. visual checking for contaminant ordeformity,
Labelling and Packing are taking place.
 This room is fitted with air-conditioners and a temperature of about 27◦C is maintained.
 This area has an inspection table where deformity and contamination arechecked against
black and white background.
 The minimum luminosity required in the inspection zone is 500lacs.
 The inspection table is fitted with stainless steel conveyors.
 The equipment is attached with a motor of 1 H.P. and a reduction gear box withadjustable
pulley.
 It is sometimes convenient to categorize packages by layer or functions –
o Primary Packaging
o Secondary Packaging
o Tertiary Packaging

Primary Packaging – It is the material that first envelope the product and holds it. This usually is
the smallest unit of distribution or use and is the package which is in direct contact with the content.
Secondary Packaging – It is outside the primary packing and may be used to prevent pilferage or to
group primary packages together.
Tertiary Packaging – These are used for bulk handling, warehouse storage and transport shipping.
The most common form of palletized unit loads that packs tightly into containers.

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 TYPES OF PACKAGING

1) BLISTER PACKING
2) STRIP PACKING

1) Blister Packing: This is useful for packaging of unit dose of pharmaceuticals. This packing
mode has been used extensively for several good reasons. It is a packaging configuration capable
of providing excellent environmental protection, coupled with an aesthetically pleasing and
efficacious appearance. It also provides user functionally in terms of convenience, child
resistance and now temperature resistance.
Blister packing consists of two principals’ components: -
a. A formed base web creating the cavity inside which the product fit.
b. The lidding foil for dispensing the product out of the pack.

1) Strip packing: The blister package is formed by heat softening a sheet ofthermoplastic resin
and vacuum drawing the softened sheets of plastic into a

15
contoured mould. After coming, the sheet is released from the mould and proceeds to the filling
station of the packaging machine. The semi-rigid blister previously formed, is filled with the
product and lidded with a heat sealable backing material. The backing material can be either a
push through or peelable type. For a push through type of blister, the backing material is usually
heating seal coated aluminum foil. The packaging of the final product is done in paper cartons,
manually, and is finally sealed using an automatic sealer. The machine can seal cartons.

16
QUALITY
CONTROL

17
 Quality Assurance & Quality Control in
Pharma Industry
QA: It is the sum total of the organized arrangements with the objective of ensuring that products will be
of the quality required for their intended use.

GMP: Is that part of Quality Assurance aimed at ensuring that products are consistently
manufactured to a quality appropriate to their intended use.

QC: Is that part of GMP concerned with sampling, specification & testing, documentation &
release procedures which ensure that the necessary & relevant tests are performed & the
product is released for use only after ascertaining its quality.

Quality Assurance (QA) Management Procedure:

1. How to write Standard Operating Procedure:

 SOP describes standard SOP format that you can use immediately for yourquality procedure.
 SOP has instructions on how to write a formal operating procedurefor your systems
which yourpeople can follow every day.
2. Quality Documentation Management and Change Control:
 This SOP describes how to generate new quality documents or change control of existing
documents,review of quality documents, satellite file management, and role of document
author, approver, document control officer and satellite file administrator.
3. Documentation Rule for GMP Documents:
 This SOP describes the principles to be followed in GMP documents, entry of data and
information,signature requirements and correction technique of incorrectly entered data or
information.
4. Quality Documentation-Control, Tracking and Distribution:
 In this SOP you will find mainly the role of document control officer during the initiation,
creation,circulation and approval of new qualityrelated documents.
 It also describes the procedure of modification and reviewof existing document
using adocumentation database.
 Management of existing and superseded documents is also a part of thisprocedure.
 You will see all the forms referred during the instruction are attached at theend of the procedure.
5. Shelf Life of Product:
 This simple SOP describes the meaning of shelf life and provides on how to interpret shelf
lives andstorage conditions for your raw materials from the Certificate of Analysis,
determining expiry date for your finished products by use of raw material date of
manufacturing and their shelf lives.

18
 Quality Control work (Summary)

Sampling of active pharmaceutical ingredients, Excipients, finished product & packing material
etc.

1. Testing of API (Active Pharmaceutical Ingredients).

2. Testing of excipients.
3. Testing of sample process.
4. Testing of finished products.
5. Testing of packing material.
6. Stability studies of finished product.
7. Maintenance and calibration of instruments.
Procurement of chemicals and glass ware
8. Procurement of reference standard.
9. Procurement of maintenance of clusters for microbiological testing.
10. To certificate analysis.
11. To study products complaints.
12. To destroy the control sample after six month of the date of expiry.

Quality control department

1. Quality control sampling section:

Responsibilities:-

 To draw the sample of RM from store.

 To draw the samples of F.G. from production department.
 To keep control sample for reference & for stability studies.
 Final inspection of each batch.

19
 2. Quality control chemical section:

Responsibilities:-

 Complete analysis of all RM/ process & F.G. sample as per prescribedstandard.
 To send report to production, store, Q C office.
 To carry out stability testing etc.
 Instrument maintenance and calibration.
3. Quality control microbiology section:

Responsibilities:-

 Microbiological analysis of RM/process/FG/sample.

 To send report to production, store, QC office.
 Quality control packaging material test.
 To carry out stability testing.
4. Quality control office:

Responsibilities:-

 To make certificate of analysis of R.M. &finished products.

 To maintain & keep records of analysis & certificate of analysis.

20
WORKING OF QUALITY CONTROL: -

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22