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A

Report Submitted to

SVKM’s

Narsee Monjee Institute of Management Studies (NMIMS)

Shirpur

As a part of Industrial training for B.Pharm + MBA (Pharma Tech)

By

Anvi Jain

Under the guidance of

_Dr. Payal R. Dande

School of Pharmacy & Technology Management

Shirpur

2019
Statement by the Candidate

As required by University regulation, I wish to state that the work embodied in this report
reflects the work done / learning in the organization by me. If the report sounds to be fictitious,
manipulative or plagiarized, the Institute has a right not to accept the report and reject the
same.

(Anvi Jain)

Forwarded through
Payal R. Dande

Dr. A.S. Deshpande


Associate Dean
SPTM, NMIMS, Shirpur

School of Pharmacy & Technology Management

Shirpur
ACKNOWLEDGEMENT

It is a matter of great privilege and pleasure for me to present this report of my


one month of industrial training as part of my Internship at Zest Pharma. First
of all I would like to thank Dr. (Prof.) R.S.Gaud (Director NMIMS , Shirpur
Campus) , Dr. A.S. Deshpande ( Associated Dean , NMIMS Shirpur Campus), Dr.
Sateesh Belamkar (Placement In-charge ) and Dr. Payal Dande (faculty guide )
for providing me constant support and also giving me the opportunity to do my
internship at Zest Pharma.

I would also like to thank Dr. Sudhir Vohra who took care my internship related
activities and introduces me with the firm and its corporate culture.

I would like to express my sincere gratitude to the members of my department


Mr. Sidharth Dubey , Mr. Devendra , Mr. Sumit , Mr. Amit for providing me
with their invaluable support throughout the duration of the Internship and
also sharing their knowledge with me and providing with priceless learning
experience.
INDEX

S.No.

1. Introduction

2. Commercial & Facility Details

3. Organogram of Department & Site Layout

4. Manufacturing &Manpower

5. Week 1

6. Week 2

7. Week 3

8. Week 4

9. Conclusion
INTRODUCTION

ZEST is a technology and experience driven company in healthcare sector with


OWN ultra modern WHO GMP Certified manufacturing UNIT with ISO 9001 –
2008 accreditation and an array of laurels to stamp the quality standards and
its QUALITY maintenance.

ZEST has made its presence felt in the Pharma Industry and the trade across
the GLOBE for its just one strong trait, that is “QUALITY”. We do strongly
believe in extending the healing hands to the suffering human being.

1994 was the foundation year of ZEST when a Dreamer turned his dream to
Reality by entering into the Pharma world with BIG vision. Vision was to extend
a helping hand to the suffering human being by offering quality products at
affordable prices. To alleviate their sufferings / diseases by making products
GLOBALLY.

The starting point of the long journey was from domestic ethical, contract &
institutional businesses. Later on 2000 ZEST commenced its overseas business,
the overseas operations received a thumps up welcome due to our
commitment for quality ensured by own WHO-GMP certified manufacturing
facility.

Today ZEST is present in many countries and the process of adding up the
clientele continues and the list is growing rapidly.
Mission & Vision

ZEST had vowed, “not to compromise in QUALITY at any step and under any
condition.” That TRUST has been acknowledged and appreciated by the
CLINICIANS all over with warmth. Our penchant to be acclaimed as “THE BEST”
in the Industry has been backed up by 3Q Mark… Quality Products, Quality
Presentation, Quality Representation.

This philosophy has become possible only by the conscientious efforts of the
people with the word QUALITY deeply embedded in their hearts and minds.
Hence ZEST was adjudged the BEST in the Country when it won the NATIONAL
AWARD for QUALITY of its Products.

ZEST is committed to grow in its special Therapeutic Segments backed by our


knowledge, Expertise and QUALITY ON TOP Products because the PRODUCTS
of ZEST are manufactured in its very OWN Sophisticated Manufacturing Unit
equipped with the modern machineries with high technical configuration and
capacity backed by the WHO GMP compliance.

Nature of Business Manufacturer


Additional Business Wholesaler

Service Provider
Company CEO Sudhir Vohra
Year of Establishment 1993
Commercial & Facility Details

Zest is an experience driven pharmaceutical manufacturing and


marketing company, where quality products & people always come
first. Zest Pharma is engaged in the manufacturing and marketing of
finished dosage forms FDFs in India . Zest achieves its growth &
profitability through quality products and services, increasing
investments in product innovations and through its competent
scientific and managerial manpower. Zest has a strong presence in the
pharmaceuticals markets in India and developing international
markets. Zest Parma will continuously strive to improve healthcare
standards, with its state of the art manufacturing facilities to
manufacture and supply, standardized formulations with global
quality.
The Company has catalyzed its growth through investments in fully
functional and dedicated research and development based
manufacturing facility and its capabilities to produce quality products.
Zest today has well-built brand portfolio of 45 Branded Products
including Gynaecological and GP segments.
The Company is all set to launch its ambitious OTC Division having A
class quality products.
Organogram of Department & Site Layout
Manufacturing &Manpower

Women make up approximately 50 percent of 1 billion Indian population.


Globally more than 61 percent of physician visits are made by women, 59
percent of prescription drugs are purchased by women and 75 percent of
nursing home residents over age 75 are women. However, women as a
group have long been overlooked when it comes to research studies
targeting health concerns. In India this problem is compounded by a social
bias against women, ignorance and lack of education.

ZEST Pharma is committed to improving the quality of Women's health by


enabling the Gynaecologists, Physicians and other healthcare providers for
women to not only improve their lifespan but also their quality of life.
Trends indicating indifference to women's health underscore the need for
committed Pharma marketers to collaborate with physician groups to
organize systematic disease prevention and exercise programs for female
patients. Zest aims to work hand in hand with the medical fraternity in
leveraging the global research and increasing understanding of human
diseases to improve healthcare for women in Asia and in particular in India.
Week 1
Production of tablets:-

Common equipment used in pharmaceutical tablet manufacturing include:

1. Size reduction equipment/ communition


equipment e.g., hammer mill, vibration mill, roller mill, pin
mill, fluidized energy mill, end-runner mill, edge-runner mill, cutter
mill and ball mill.
2. Weighing balance/ balances e.g., bulk weighing balance (weighs in
kilogram), electronic weighing balance (weighs in grams and
milligrams).
3. Mixing equipment e.g., pneumatic mixers (air-mix mixer or air-drive
mixer), diffusion/ tumbling mixers (e.g., V-blender, double cone
blender, cubic mixer, drum blender), convective mixers (e.g., ribbon
blenders, orbiting screw mixers, horizontal high-intensity blenders,
planetary blenders, diffusion mixer with intensifier bar/agitator,
Forberg blenders, horizontal double arm mixers, vertical high-
intensity mixer).
4. Granulators e.g., rotating shape granulators, mechanical agitator
granulators (e.g., ribbon or paddle blender, sigma blade mixer,
planetary mixer, orbiting screw mixers), high-shear
granulator, fluidized bed granulator, dry granulator etc.
5. Dying equipment e.g., spray dryer, rotary dryer, fluidized bed
dryer etc.
6. Tabletting machine – single punch tablet press and multi-station/
rotary tablet press (e.g., High-speed rotary tablet machines and
multi-layer rotary tablet machines).
7. Quality control equipment e.g., disintegration equipment (Manesty
single unit disintegrating apparatus or Erweka multiple unit
disintegrating apparatus), USP Dissolution Tester, Tablet Hardness
Tester, Tablet Thickness Tester, Tablet Friability Testers etc.
8. Coating and polishing machines for coated tablets e.g., standard
coating pan, perforated pan, fluidized bed/ Air suspension coating
system etc.
9. Packaging machines e.g., blister packaging machines, strip packing
machine, aluminum foil packaging machine, etc.

Tablet Manufacturing Equipment continues to improve in both production


speed and uniformity of the tablets compressed.
Steps Involved In Tablet Formulation/ Procedure for Manufacturing
Tablets

1. Dispensing: Each ingredient in the tablet formula is weighed and


accurately dispensed as per dose. This is one of the critical steps in
any type of formulation process and should be done under technical
supervision.
2. Sizing: Formulation ingredients must be in finely divided form,
otherwise, size reduction should be carried out for better flow
property and easy mixing.
3. Powder blending: Powders are mixed using a suitable blender to
obtain a uniform and homogeneous powder mix. The drug substance
and excipients are mixed in geometric dilution.
4. Granulation: Here small powder particles are gathered together into
layers, and permanent aggregates to render them into free-flowing
states.
5. Drying and dry screening: Screened wet granules need to be dried
for a particular time period in tray dry or fluid bed dryer at
controlled temperature not exceeding 550C. Dried granules are
screened through the appropriate mesh screen.
6. Tablet compression: This step involves the compression of granules
into a flat or convex, round, oblong, or unique shaped, scored or
unscored tablets; engraved with an identifying symbol and/ or code
number using tablet press.
7. Coating: Tablets and granules are coated if there is need to mask the
unpleasant taste/odour of some drug substance or to increase the
aesthetic appeal of uncoated tablets as well as to modify the release
or control the release of drug substance from tablets. This is achieved
by enclosing or covering the core tablet or granules with coating
solutions.

Some of the steps above are skipped depending on the manufacturing


process used during tablet formulation.

Techniques/ Methods used in tablet Formulation

Tablets are commonly manufactured by

i. Wet granulation
ii. Dry granulation or
iii. Direct compression.
Evaluation/ quality control of raw materials used in the manufacture of
tablets

Quality control of tablet raw materials (APIs and excipients) is one of the
main tasks of the quality control unit in any drug manufacturing industry.
Raw materials described in monograph of relevant Pharmacopoeia must
undergo the necessary tests as stated in the monograph. It is often
sufficient if identification testing is conducted on the individual
packages/containers and content and purity determination in mixed
samples.
Every manufacturer has the opportunity to carry out further testing if they
deem it necessary for guaranteeing a smooth running production process
or a very high-quality product. Starting materials are released only after
their quality are established or judged as satisfactory. Raw materials that
fail the quality control test are rejected and returned to the supplier.
Any risks that may emanate from starting materials of inappropriate
quality must be avoided to prevent product failure and to ensure a
consistent level of quality, as well as safety in consumer and industrial
products.

IPQC:-

 Weight variation
 Dissolution
 Disintegration
 Friability test
 Hardness test
 Thickness’
 Assay Test
 Uniformity Test

Types of coating

 Film coating
 Sugar Coating
 Enteric Coating
Week 2
I was assigned for another department which was beta lactum, the
guide who was assigned to me for this was Siddhart sir .He explained
me all types of mixer which is used for manufacturing of Capsules
powder.

Types of mixtures

 Double shape mixer


 Mass mixer
 Octagonal mixer
 Vertical blender
 Planetary mixer

Different mixer has different speed


For octagonal – 10 rpm

In this department, we were not allowed to perform on any


machines but was given brief introduction of all the manufacturing
processes which were performed in the beta lactum .This is one of
the department where all the anti biotic drugs are being
manufactured .

In the manufacturing of the capsules, different machines were being


used –

Vibro shifter which was used for size separation.

Pulvirizer- it is used for size separation.


Tray dryer- used for drying purpose of powder.

In every pharmaceutical industry heap filters are being used:-

 High efficiency particulate air (HEPA) filters.


 Particles are micron size
 Home consumer air filtration products.
 Biological safety and high efficiency particulate filters.
 Filter performance and industry standards.
Week 3
I visited capsule filling machines which was semi automatic and
automatic filling machine.

Capsules filling machine are used to fill empty soft or hard gelatine
capsules of various sizes with powders, granules, semi solids or
liquids.

Semi automatic capsule filling machine-

The machine is designed to fill hard gelatine capsules of all sizes with
powders, pellets or granular materials .Depending upon the quality
and size of capsules ,ambient temperature and operator speed, the
machine consist of different parts :-

o Machine name PZ -40


o Consist of :-
o Capsule hopper
o Vertical/horizontal block
o Powder hopper
o Dosatar
o Terret
o Polisher machines]
o Empty capsule sorter
o Vacuum pump
o Aspirator
o Temperature should be maintained to 40%to 65% R.h.

Automatic filling machine:-

The main working principle of automatic capsule filling machine


is that when the machine is running, the capsules in the capsule
hopper will enter the first delivery fork of the distribution device
vertically one by one. When the first fork downward movement
will send down six capsules, and on the plastic cap. In the first
operation, the vacuum separation system runs the capsule into
the module and separates the body cap. When the rotary table
rotates intermittently to the second work, the upper meter rises
rapidly and moves inward. In the fifth work, the filling rod
pushes the compacted charge column into the capsule of the
lower module. The unseparated capsules are excluded in the
eighth work. The upper and lower modules are combined in the
10th work, and the lower capsule body is pushed to the upper to
make it buckle. In the 11th work position, the buckled capsule
finished products are pushed out and collected. At station 12, the
vacuum cleaner clears the module and enters the next cycle. The
charge column is formed by five times of filling and compaction
in the intermittently rotating gauge plate.

o Power: 380V Three-Phase Four-Wire 50HZ 5.68kw

o Compressed Air: 0.03m3/min,

o Pressure 0.4mpa

o Working Environment: 21 ℃+ 3 ℃

o Relative Humidity: 40 ~ 60%

o Equipment manufacturer:

o Reference Mode: NJP-1200

o Maximum Capacity :1200pcs/minute

o Capsule Size : 00# —5#

o Loading Rate : >99%


o Loading Difference: <5%

o Total power:4.8kW

o Motor1.5KW , Vacuum 1.1KW ,Dust Suction 2.2KW.

o Power Supply :380 v, 50 hz

o Overall Dimensions :L*W*H(mm) :1000*860*1900

o Weight :95kg
Dry Syrup filling machine:-

Model: AHPF -80AS.


. Automatic Double Head Auger Type Powder Filling Machine

 Product Details
Salient Features
 A.C. Frequency Drive
 Servo Driven for Auger & Star wheel
 No Bottle – No Filling System
 PLC with HMI
Optional Accessories
 Acrylic Cabinet
 Pre / Post Nitrogen purging
 30” Dia Turn Table with Independent Drive
 De – Dusting Unit
Week 4
The last i visited quality controlled department , zest pharma
believes that quality is the result of sincere efforts, skilful execution
to produce high-tech quality health care products to the specific need
of the market.

Highlights of Quality Assurance Department are: -


 Good manufacturing practice of pharmaceutical products

 Quality Control

 Sanitation & Hygiene

 Validation

 Complaints

 Product Recalls

 Contract Production & Analysis

 Self Inspection & Quality Audit

 Personnel- Personal Hygiene & Training

 Premises

 Equipment

 Material

 Documentation

Quality Policy of ZEST PHARMA:


 Products and service that totally satisfy customer needs and
expectation.
 To be customer oriented company.

 Continual improvement of processes based on objective measurement.

 Total employee involvement.

 Total Quality Management.

 Continual improvement of process/ system.


Conclusion
As this was the first time I was face to face with real world I am very lucky that
I did my internship at zest pharma.

Here I saw how my theoritical knowledge was applicable in real life and in real
situation and I also tasted the corporatle life.As the main objective was to get a
gist of the functioning of a corporate and also I was able to personally
experience functioning of all the production departments.. I also learne dhow
all department are like links of a chain and work in a proper synergy. I learned
tht most desirable trait of an employee that a company is looking for is quality
and efficiency. I worked with highly skilled and trained staff that had a huge
responsibility and I fell lucky tthat they shared some of it with me. It wa sa
whole new learning experience and I am sure that it will definitely boost my
professional carrer.

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