Industrial Training Report
Industrial Training Report
Industrial Training Report
BACHELOR OF PHARMACY
By
Ajay Malhotra
B.Pharmacy (Appearing)
Roll No. BP-5012620
~1~
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 .
~2~
ENDORSEMENT BY THE PRINCIPAL
OF THE INSTITUTION
DATE:
PLACE: KATHOG
~3~
ACKNOWLEDGEMENT
~4~
INDEX
1. Introduction 6
2. About Company 7
3. Quality Management 8
4. Manufacturing Facilities 9
6. Company Management 10
7. Products 11-16
8. Facilities 17-20
9. Warehousing 21
10. Summary 22
11. conclusion 23
~5~
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
~6~
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
~7~
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
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
Our commitment to quality and adherence to best practices has proven itself time and again.
exceptional value to customers. To this end the company has been certified by various
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,
Systems.
“We strive for Total customer satisfaction through continuous improvements in processes and
~8~
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
~9~
Company Management
~ 10 ~
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
~ 11 ~
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
~ 12 ~
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.
~ 13 ~
PRODUCTION DEPARTMENT OF TABLET :
EVALUATION OF TABLETS :
~ 14 ~
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]
~ 15 ~
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.
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.
~ 16 ~
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.
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.
~ 17 ~
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.
~ 18 ~
3. TABLET PUNCHING MACHINE
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
~ 19 ~
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
~ 20 ~
Warehousing
~ 21 ~
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.
~ 22 ~
CONCLUSION
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.
~ 23 ~