Industrial Training Report

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INDUSTRIAL TRAINING REPORT

A training report submitted to

Himachal Pradesh Technical University, Hamirpur

In the partial fulfillment of the requirement for the degree of

BACHELOR OF PHARMACY
By
Ajay Malhotra
B.Pharmacy (Appearing)
Roll No. BP-5012620

Under the guidance of


Mrs. REEMA SINGH

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DECLARATION BY THE CANDIDATE

I Mr. Ajay Malhotra S/O Mr. Suresh Singh bearing the registration
number 501-BP2620 student of laureate institute of pharmacy, Kathog,
Jawalaji, H.P. has underwent one month of Industrial Training Report in
Gracure Pharmaceutical Ltd. from a period of 01 July 2018 to 01 Aug
2018 and fulfillment for the award of degree of pharmacy for the academic
year 4th .

Ajay Malhotra (B PHARM 7th Sem)


Reg. No: 501-BP2620

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ENDORSEMENT BY THE PRINCIPAL
OF THE INSTITUTION

This is to certify that the “ONE MONTH INDUSTRIAL TRAINING


REPORT” is a bonafide work of Mr. Ajay Malhotra, under the guidance
of Mrs. Reema Singh, HR of The Gracure Pharmaceutical Ltd.

Dr. M.S.ASHAWAT M. Pharm., Ph.D.


Professor and Principal
LAUREATE INSTITUTE OF PHARMACY
KATHOG-177101 JAWALAJI (H.P.)

DATE:

PLACE: KATHOG

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ACKNOWLEDGEMENT

First of all, I would like to express my gratitude to almighty GOD MY


PARENTS to enabling me to complete this report.
I feel very proud to say that due keen knowledge of the working members of
Gracure Pharmaceutical Ltd. Bhiwadi (Raj.) It was very easy to learn a lot
of knowledge regarding Production and other departments also.
Successfully completion of any type of project require help from a number of
persons. I have also taken help from different people for the preparation of
this report. Now, there is little effort to show my deep gratitude to those
helpful persons.
I am greatly thankful toHR Mrs. Reema Singh for his support and guidance to
successfully complete my training.
Finally. I would like to acknowledge my sincere thanks to Mr. Rakesh
Verma (SENIOROFFICER) Production, Gracure Pharmaceutical Ltd. who
helped me and co-operated with me during my training. I have highly
benefited by this training and have gained a lot of knowledge about the
various processes and technique employed in various department in the
Gracure Pharmaceutical Ltd.

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INDEX

Sr.No. CONTENT Page no.

1. Introduction 6

2. About Company 7

3. Quality Management 8

4. Manufacturing Facilities 9

5. Research & Development 9

6. Company Management 10

7. Products 11-16

8. Facilities 17-20

9. Warehousing 21

10. Summary 22

11. conclusion 23

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INTRODUCTION
Gracure Pharmaceutical Ltd. company has dedicated and Government approved R &
D department well equipped with the latest equipments and is supported by a large pool of
scientists who continuously work towards new products. The R&D is involved in developing
generic pharmaceuticals encompassing all oral solid and liquid dosage form including tablets,
capsules, syrups & external preparations including ointments & gels

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The company has dedicated and Government approved R & D department well equipped
with the latest equipments and is supported by a large pool of scientists who continuously
work towards new products. The R&D is involved in developing generic pharmaceuticals
encompassing all oral solid and liquid dosage form including tablets, capsules, syrups &
external preparations including ointments & gels
Gracure Pharmaceutical Ltd. is a Delhi based pharmaceutical company, established in 1992
by Mr. A.S Bhargava with the vision of making world class affordable medicines. Gracure is
a research driven forward looking pharmaceutical company with expertise in development of
various finished dosage.
Since its inception in 1992, Gracure pharmaceuticals Ltd. has been focused to manufacture an
extensive spectrum of pharmaceutical formulation products.
We engage in the research, development, manufacturing, sourcing, marketing, and
distribution of high-quality pharmaceutical products. We are a fully integrated company with
in-house business development, R&D, manufacturing and regulatory compliance capabilities.
With the assistance of latest equipments, the automated and modern production process has
been prepared. We offer a complete range of products with prompt and reliable assistance for
all our customers.
Consequently, our large-scale production capacities, highly qualified production, and quality
control staff, state of art EU-GMP certified manufacturing facility combines to give a perfect
environment for outsourcing or contract manufacturing pharmaceutical products. This
synergy allows us to provide the highest quality products to our clients in a timely manner
that is extremely cost competitive.
Our manufacturing facilities are located in Bhiwadi, Rajasthan.
Highly and professionally educated employees play an important role in the development of
the company who continue to permanently educate and improve themselves in order to
broaden the knowledge base and improve expert skills. All members of our organization are

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fully committed to quality and compliance to ensure our products meeting the highest quality
standards.
Our clients span from small startup biopharmaceuticals to the world’s largest pharmaceutical
companies.

QUALITY MANAGEMENT

A Quality par-excellence, delivering seamlessly is our hallmark.

Gracure’s quality supervision is demonstrated at all phases of product life cycle. Quality

evaluation begins with careful documentation. This ensures compliance with good laboratory

practices and consequently integrity of the data produced. Quality supervision is continued

for production, distribution and conclusion for shelf life of product.

Our commitment to quality and adherence to best practices has proven itself time and again.

Gracure couples product innovation with standardized manufacturing processes to deliver

exceptional value to customers. To this end the company has been certified by various

independent bodies and has memberships with premier industry associations.

We at Gracure Pharmaceuticals Ltd. are committed to supply good quality products, excelling

laid down standards to delight our customers by continually upgrading our skill, technology,

processes and complying to Good Manufacturing Practices and Quality Management

Systems.

“We strive for Total customer satisfaction through continuous improvements in processes and

systems, delivering consistent quality meeting International standards”

Our Motto is “On Time In Full”.

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RESEARCH & DEVELOPMENT

Gracure Pharmaceuticals Ltd. is a Delhi based company having Certified and approved
Research & Development Center by DSIR, Government of India
It has a fully equipped Research and Development Laboratory headed by highly qualified &
experienced persons to develop different formulations according to buyers /market
requirement.
Promoting wellness is a way of life with us. We have a knack of exceeding expectations
through constant product improvisation.
Our state of art Research & Development Centre spread over the area of 2,500 sq.ft sq.ft. is
engaged in continuous development processes in different therapeutic categories.
With the capability to develop 10 products per year, we are regularly building and updating
our product portfolio to cater to generic companies globally.
Our global expertise in Product development & Analytical development complemented by a
controlled supply chain enables us to provide our customers with high quality products at
competitive prices.
The facility has qualified persons in Regulatory and Project support to file dossiers for
various territories.

MANUFACTURING

Gracure Pharmaceuticals Ltd, a leading Contract Research Organization operates its


manufacturing facilities from Bhiwadi (Rajasthan) & Nalagarh (Himachal Pradesh). The state
of the art facilities is developed as per current GMP guidelines.
The pharma company possesses a cumulative manufacturing capacity of 8,000 sq.mt. With
qualified, trained and dedicated work force we try to maintain adherence to established
quality standards assures safety and efficacy of drug products.
There is an availability of adequate premises and space with suitable storage and
transportation. The production of various formulations is done in compliance to Approved
procedures and instructions.
Our manufacturing capabilities include solid orals (coated tablets, uncoated tablets, hard
gelatin capsules), liquids (syrup, suspension), dry syrups (dry powder syrups), external
preparations (gels, creams, ointments).

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Company Management

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PRODUCTS

Our network consists of customers and partners in over 20+ countries. Perhaps the only thing
larger than our network is our product range.
Proving our mettle time-and-again – we produce cutting-edge products that keep diseases at
bay. Our integrated manufacturing capability at Bhiwadi, Rajasthan, provides a portfolio of
the highest quality generic products.
 ANTHELMENTIC
 ANTIMICROBIAL
 ANTIHISTAMINE / RESPIRATORY DISORDER
 ANTIMALARIAL
 ANTIPYRETIC/ANALGESIC/ANTISPASMODIC
 CARDIO
 CEPHALOSPORIN AND BETA LACTUM
 CNS & NEURO
 ERECTILE DYSFUNCTION
 GASTROINTESTINAL
 VITAMIN/MINERAL & OTHER SUPPLEMENT
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Tablet
A solid dosage form containing medicinal substances with or without suitable
diluents; it may vary in shape, size, and weight, and may be classed according
to the method of manufacture, as compressed tablet.

Capsules
A shell usually of gelatin for packaging something (as a drug or vitamins); also :
a usually medicinal or nutritional preparation for oral use consisting of the shell
and its contents

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Ointment
An ointment is a preparation of a medication for topical use that contains an oil
base – essentially a preparation of water in oil.

Oral Powder
Oral powders are preparations consisting of solid, loose, dry particles of varying
degrees of fineness. They contain one or more active ingredients, with or
without excipients and, if necessary, authorized colouring matter and flavouring
substances.

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PRODUCTION DEPARTMENT OF TABLET :

 Specially tablets ,capsules and creams preparation are manufactured in


Swiss Garnier Life sciences .

 TABLETS : According to IP pharmaceutical tablets are solid &


biconvexdiscs, prepared by containing a drug or a mixture of drugs with
or withoutdiluents.

 InSwiss Garnier Life sciences various type of tablets are manufactured


like :
a. Sugar coated tab.
b. Film coated tab.
c. Enteric coated tab.
d. Multiple coated tab.

 For these production they required specific type of :


1. DILUENTS
2. BINDER ADHESIVE
3. DISINTEGRANS
4. LUBRICANTS
5. GLIDANTS & FLOW PROMOTERS
6. COLOURS, DYE & SWEETENERS

EVALUATION OF TABLETS :

 Tablets are evaluated for their chemical characteristics like


potency,content uniformity & purity & physical characteristics like :
a. Weight & weight variation. ( 20 Tab. )

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b. Limit : 10% - 130 mg , 7.5% - > 130 mg , 5% - > 325 mg.
c. Hardness – Pfizer & Monsanto tester
d. Thickness
e. Friability – friability apparatus
f. Disintegration test - tab. Time not more than 15 min.
g. Dissolution test – Dissolution apparatus.

MACHINES :
1. Mechanical sifter
2. Multimill
3. Mass mixer
4. Fluidized Bed Dryer
5. Coating pan
6. Single rotatory 23 station machine
7. Tablet Blister packaging machine
8. Tablet strip packaging machine
9. Tablet alualu packing machine.
Typical content of a process flow diagram

Process flow diagrams of a single process unit will typically include the
following:[4]

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 Process piping
 Major bypass and recirculation lines
 Major equipment symbols, names and identification (either by name, number or
both)
 Flow directions (indicated by arrows on the process streams)
 Pressures and temperatures, as well as other control valves and systems that
monitor and control the operation of the process (shown schematically, rather
than in complete detail)
 Interconnecting lines with other systems (if any)
 Pressures, temperatures, flow rates and other pertinent operational values for
each of the equipment items such as pumps, gas compressors, distillation
columns and other vessels
 In some cases, the process flow diagram includes a material balance that lists
the normal temperature, pressure, amount and composition of all the major
process streams. Also included, in some cases, are the amount of heat provided
by any process furnaces and the amount of heat exchanged by any process heat
exchangers.

The adjacent drawing depicts some of the typical symbols[5] used in a process
flow diagram to indicate the major equipment items.

Process flow diagrams generally do not include:

 Pipe classes or piping line numbers


 Pipe sizes
 Process control instrumentation (sensors and final elements) in detail
 Minor bypass lines
 Isolation and shutoff valves
 Maintenance vents and drains
 Relief and safety valves
 Flanges (if any)

The adjacent image provides some examples of the typical symbols used
in PFDs to represent various major equipment items, piping and valves. It
is by no means completely inclusive, but it is representative of the great
many such symbols commonly used in drawing PFDs.

Process flow diagrams of multiple process units within a large industrial


plant will usually contain less detail and may be called ''block flow
diagrams'' or ''schematic flow diagrams

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FACILITIES

1. MIXERS

Mixers are the equipments used for carrying out mixing of various excipients
with the active pharmaceutical ingredient of any formulation. They are of
different types depending upon the physic al form the dosage form.

SIGMA Z BLADE MIXER

2. DRYERS
These are the equipments used for carrying out the drying process at
laboratory and industrial scale. Variety of such equipments are available that
can be used depending on characteristics of the excipients and APIs being
used for the production of formulation.

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FLUIDIZED BED DRYER

3. GRANULATORS

Equipments used for carrying out the granulation process. Now-a-days some
dryers are being used for granulation as well as drying purpose; prolonging the
stability of the prepared granules.The unit is same as fluidized bed dryer. When
the unit is used as granulator the dry ingredients are placed in the chamber and
fluidized while the granulating liquid is sprayed into the bed causing the
particles agglomerate into granules.

FLUIDIZED SPRAY GRANULATION

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3. TABLET PUNCHING MACHINE

TABLET EVALUATION APPARATUS

CAPSULE PRODUCTION

 Capsules re solid dosage form usually containing one dose of drug enclosed
within a small, water soluble shell of a suitable form of gelatin.
 Hard gelatin capsules : 000, 00, 0, 1, 2, 3, 4, 5.
a. Processing of hard gelatin capsules
b. Formulation of hard gelatin capsules.
c. Diluents
d. Protective sorbents
e. Glidants
f. Antidurting agent

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EVALUATION OF CAPSULES :
1. Weight variation
2. Content uniformity
3. Disintegration test
4. Dissolution test
Manufacturing of capsules is done by Hand Capsule filling machine

QUALITY ASSURANCE AND QUALITY CONTROL:

Quality is the mainstay of our competitiveness.


At Scott-Edil they take considerable focus in adherence to the QA policies.
Their policies direct our operation to constantly create an environment of
quality and compliance in line with the best recognized global practices.
Quality Assurance, though an independent function, works as an interface
between R&D and manufacturing strictly abiding with the standardized
quality system, providing consistency, effectiveness and efficiency for all
manufacturing activities of APIs across all their manufacturing locations.

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Warehousing

Warehousing management in the pharmaceutical Industry has its own set of


unique rules that have to be adhered to, in order to stock, pick, and ship product
in a way that conforms to the many regulations that the market sector demands.
At Proteus Software, we understand the warehouse management requirements
of the Pharmaceutical sector, resulting in fully function systems that ensure that
stock is always handled, not only in the correct, but also most efficient and cost
Effective manner.

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SUMMARY
During my training period, in the industry I acquired lots of experiences in
Pharmaceutical Production and Production management. This will help me to
clarify my theoretical knowledge. I hope and pray that it will help me much in
my future profession.

During our training period, we had seen various instruments and apparatus in
the industry. The highly sophisticated instruments that work precisely must be
operated with intense care for optimum use. We could acquire a lot of
information regarding the latest instruments and their working procedures.

It was taught to us that, the CGMP guidelines are to be strictly followed in the
industries in each and every section. And the same guideline was seen followed
Gracure Pharmaceutical Ltd.It helped us to acquire knowledge on
punctuality, regularity and working environments in industries.

Training in Gracure Pharmaceutical Ltd. reshape my mind in different


sectors based on education, communication and interactions, zero determination
of error, commercialization and many more.

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CONCLUSION

Industrial training is very much essential for Pharmacy Students. It is also a


great opportunity to acquire practical knowledge. During my training period, in
the industry I acquired lots of experiences in Pharmaceutical Production and
Production management. This will help me to clarify my theoretical knowledge.
I hope and pray that it will help me much in my future profession.

During our training period, we had seen various instruments and apparatus in
the industry. The highly sophisticated instruments that work precisely must be
operated with intensecare for optimum use. We could acquire a lot of
information regarding the latest instruments and their working procedures.

It was taught to us that, the CGMP guidelines are to be strictly followed in the
industries in each and every section. And the same guideline was seen followed
Gracure Pharmaceutical Ltd. It helped us to acquire knowledge on
punctuality, regularity and working environments in industries.

Training in The on reshape my mind in different sectors based on education,


communication and interactions, zero determination of error, commercialization
and many more.

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