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Shivam Ind. Training Final
Shivam Ind. Training Final
A Report on
INDUSTRIAL
TOUR (BP815P)
Submitted to the
Dr. A.P.J. Abdul Kalam Technical University, Uttar Pradesh, Lucknow
IN PARTIAL FULFILLMENT
OF THE REQUIREMENTS FOR THE DEGREE OF
BACHELOR OF PHARMACY
(B. Pharm. 8th Semester)
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COLLEGE OF PHARMACY
JSS ACADEMY OF TECHNICAL EDUCATION
C-1/A, Sector-62, Noida, (U.P.) India
JSS MAHAVIDYAPEETHA
COLLEGE OF PHARMACY
JSS ACADEMY OF TECHNICAL EDUCATION
C-1/A, Sector-62, Noida-201301 (U.P.) India
(Affiliated to Dr. A.P.J. Abdul Kalam Technical University, Lucknow, U.P.)
CERTIFICATE
This is to certify that this report entitled “A Report on Industrial Tour
(BP815P)” submitted to Dr. A.P.J. Abdul Kalam Technical
University, Uttar Pradesh, Lucknow, in Partial Fulfillment of The
Requirements for The Degree of Bachelor of Pharmacy (B. Pharm. 8th
Semester) is a bonafide record of work done by Mr. Shivam Singh under
my supervision during B. Pharm. 8th Semester (2023-24).
SUPERVISOR
Dr. Sonam
Patel, (M. Pharm,
Ph.D.,) Asst.
Professor,
Dept of Pharmaceutical Chemistry
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JSS MAHAVIDYAPEETHA
COLLEGE OF PHARMACY
JSS ACADEMY OF TECHNICAL EDUCATION
C-1/A, Sector-62, Noida-201301 (U.P.) India
(Affiliated to Dr. A.P.J. Abdul Kalam Technical University, Lucknow, U.P.)
CERTIFICATE
This is to certify that this report entitled “A Report on Industrial Tour
(BP815P)” submitted to Dr. A.P.J. Abdul Kalam Technical
University, Uttar Pradesh, Lucknow, in Partial Fulfillment of The
Requirements for The Degree of Bachelor of Pharmacy (B. Pharm. 8th
Semester) is a genuine record of work done by Mr. Shivam Singh under
supervision of Dr. Sonam Patel during B. Pharm. 8th Semester (2023-
24).
PRINCIPAL
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Report on Industrial Tour (BP815P)
DECLARATION
STUDENT-TRAINEE
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AKNOWLEDGEMENT
This report could not have been completed without the encouragements from the students who have
attended the Industrial Training program in past few weeks, as well as the support from the
organizations which the students have completed their Industrial Training from.
Special gratitude to Dr. Sonam Patel who has provided the valuable time and efforts to complete
this Industrial Training report fruitfully.
In addition, insightful suggestions provided by the College of Pharmacy, JSSATE, Noida, His
holiness Swami Ji, Principal Jss college of pharmacy Ooty & Mysore, Joint director Dr.H.G.
Shivakumar and Principal Dr. Mohd. Afzal Azam to make this report successful.
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Report on Industrial Tour (BP815P)
TABLE OF CONTENTS
1. G.M.H. Laboratories
Introduction
History
Manufacturing
Quality
Certifications
R&D
Products
Premises
2. ASIAN PHARMA
Introduction
History
Instruments
Service
Conclusio
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G.M.H. Laboratories
INTRODUCTION
GMH was established in the year 1995 with the prime objective of Manufacturing, Marketing,
Promoting of Pharmaceutical Specialties and making medicines available also to the man-kind
living in the farthest interior and remote places. Over the last 15 years the Company has made
progress and is today a leading medium scale Pharmaceutical Company in the area of Health Care.
The Pharma division specializes in manufacturing Active Pharmaceutical Ingredients (APIs) and
stabilized vitamins. Over the past 29+ years, through our advanced R&D facility, we have been
continuously enhancing the ingredients used in the manufacture of formulations. We manufacture
and supply the following APIs that conform to various international Pharmacopoeias such as IP,
BP and USP.The dedicated R&D division conducts ongoing research to enhance usefulness, quality
and stability of several vitamins using various techniques such as microencapsulation, coating, spray
drying etc.
Use of vitamins is very common in food & pharma industries. They are used extensively in the
preparation of multi-vitamins, food supplements, beverages, gummies and at times for specific use in
therapeutic preparations. They are generally used in minute quantities since they could pose stability
issues because of their sensitivity & multi-pronged interactions.
G.M.H's value addition is in enhancing the vitamins to increase the product's shelf life and stability
and reduce incompatibility issues.
Garcinia, Amla & Bitter Melon Extracts (manufactured in a separate herbal plant), have several
applications. These extracts are made from pesticides-free raw materials and hence are very safe for
human consumption. Elemental impurities are kept within the lowest acceptable limits and meet the
most stringent standards in the world.
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to G.M.H to manufacture and commercialize their products. Leveraging our deep connections in and
knowledge of the industry, we also help market these products.
Illustrative examples:
Black Seed Extract – amongst many of its benefits, G.M.H uses it as an ingredient in
anti- obesity and sugar control preparations
Bitter Melon Extract – Used in diabetes control under the brand name Glycostat
GMK – potassium and magnesium salt of Hydroxycitric acid used for metabolic syndrome
Fenugreek (Methi) Extract – used in metabolic disorders like Type 2 Diabetes,
normalizing bowel movement, hyperacidity, stress relief etc.
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HISTORY -
GMH was established in the year 1995 with the prime objective of Manufacturing, Marketing, Promoting of
Pharmaceutical Specialties and making medicines available also to the man-kind living in the farthest interior and
remote places. Over the last 15 years the Company has made progress and is today a leading medium scale Pharma.
GMH Pharmaceutical’s principal activities include manufacturing and marketing of prescription pharmaceutical
brands. We endlessly look forward to innovative ways of offering molecules with latest drug delivery technology.
GMH Pharmaceuticals believes in building long lasting relationship with business associates, who are our trusted
partners in organization’s growth. We have close knit family of various dealers who are constantly striving hard to
fulfil our commitment. They are providing our range of products to millions of people across the country and enable
our organization to scale new heights of professional excellence year after year.
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MANUFACTURING
G.M.H has always been current with changing technologies and manufacturing processes in the
pharma industry. All of our plants across locations feature some of the best in the world machinery
& equipment’s and follow standardized processes.
Spray drying
Vacuum drying
Spray coating
Ion exchange technology
Solubilization technology
Size reduction
Aqueous extraction
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SPRAY DRYER
These 35 feet tall equipment is excellent for micro-encapsulation as well as for drying heat sensitive
products. Minimal exposure to heat during the drying process ensures superior quality product. This
equipment enables the bulk density of the product to be varied by altering the speed as per
concentration of the solution.
VACUUM DRYER
This vacuum dryer is a very effective equipment to dry easily oxidisable products. The high vacuum
created by the equipment reduces solvent levels to the bare minimum. Low exposure to air during
the vacuum drying process improves product quality.
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This two-speed high shear mixer/granulator with an efficient chopper ensures uniform distribution of
ingredients without lump formation.
This highly effective and efficient imported mill reduces grinding time by 75% and gives finely
grounded powder which is normally not obtained in classic hammer mills.
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QUALITY
G.M.H takes pride in the quality of our work and our deliverables. Our quality processes are driven
by passionate people, stringent checks and adherence to industry needs & regulatory requirements.
Our 100% retention of our clientele is a testimony to our continuous and rigorous commitment to
quality.
We believe that quality is not a destination but a journey. Therefore, we continuously evaluate our
quality processes based on internal assessment and client feedback. Our culture of continuous
improvement in everything we do, allows us to consistently deliver high quality products, batch
after batch, year after year.
All incoming raw material is tested against pre-defined set of multiple parameters that have evolved
and been perfected over the years. These parameters include both internally defined parameters
based on 33+ years of learning and Pharmacopoeias’ standards of different countries.
Our incoming material testing is not restricted only to the raw material. All of our packaging
material also go through a similar rigor of quality checks, such as dimensions/volume, thickness,
weight, food- grade plastic test, etc.
Additionally, we also do a thorough check of the text on the labels, their size, data accuracy,
adhesiveness etc., to ensure brand safety.
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Once the raw material has passed the incoming material tests, they are accepted for production. In
order to ensure final product meets the desired quality specifications, and to avoid any last-minute
delivery delay, we perform a series of quality checks at all critical stages of the manufacturing
process. Such tests include but not limited to, content uniformity, particle size, bulk density,
moisture contentetc.
Before the product is packaged and dispatched, the product goes through a final set of tests. The
checks at this stage typically consist of microbiological tests, potency tests, residual solvents etc.,
and other checks as per client specified parameters.
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Every batch of product that we ship, we retain a sample of the shipped product. The retention period
of such samples is for a minimum of 1 year from the stated/expected shelf-life. This allows us to
determine the probable cause(s) of failure of the product post shipment, if any.
The shelf-life study adheres to ICH guidelines and ensures the product consistently meets the
assigned shelf-life parameter.
In an unlikely event that a shipped product has failed to meet the desired quality standards during
client’s testing, we conduct a thorough Root Cause Analysis. This root cause analysis is conducted
in collaboration with the client to identify and isolate the cause(s) of failure. The findings are shared
with the client in a transparent manner. This ensures that appropriate preventive measures are
identified and implemented to avoid future occurrences.
Every change in an organization, internal or visible to the client, has a risk associated with it. At
G.M.H, we take utmost care to analyze risks associated with every major or minor change. We then
identify and implement appropriate risk mitigation measures.
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CERTIFICATIONS
G.M.H takes pride in delivering products with the highest levels of quality, reliability and
consistency.
Our certifications are just an endorsement by an external entity, certifying our processes and
adherence to industry standards.
To ensure our quality is repeatable across every batch that leaves our premises, we have instituted
stringent quality processes and checks. Various certifications we have received merely establishes
our strong credentials in this area.
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Our R&D team consists of highly qualified and experienced scientists with Masters and Doctorate
degrees. Our Lab is equipped with the most apt infrastructure required for conducting cutting-edge
research and development work.
Our scientists constanlty work on developing newer techniques to improve existing processes &
technology using innovative methods. Such efforts help us to keep overall cost of production at
acceptable levels. Miniature models of production equipments in the lab ensures smooth Lab-to-
Production technology transfer. All research work is conducted as per GMP standards, maintaining
highest levels of safety and hygiene.
Our R&D efforts play a critical role in bringing new products to market and to enhance existing
products. Our R&D rigor ensures no product is ever released into the market without undergoing
stringent tests. We also have collaboration with leading hospitals and clinics to conduct clinical trials,
wherever needed.
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PRODUCTS
CAPSULES
TABLETS
OINTMENTS
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PREMISES
Dedusting Area- All the dust is removed via vaccum cleaner to remove dust during loading.
Quarantine under Test area- Sampling is done and samples are labelled
PINK Sticker Label- Already sampled material.
YELLOW Sticker Label- Under test sample.
GREEN Sticker Label-Approved test sample.
RED Sticker Label- Rejected test sample.
Raw material approved store- For keeping raw materials for sampling, analysis, and
approved. It is a 100% controlled environment storage for active and inactive raw materials.
It has HVAC system in store.
Deep Freezer- • For active materials- 100/sampling.
For inactive materials- nt 1 sampling is done.
Dispensing area- For dispensing of the sample.
Packing material store- Used for in-process quality packing. Products are labelled to prevent
misuse.
Warehouse- Checked by QA,QC Department, Approved products are kept here.
Storage area- To store the products with adequate Ventilation, temperature, humidity,
light, odors and all other requirements necessary for the maintenance of respective
products.
Production layout- • It is divided into: -
Manufacturing area
Vitamin D3 preparation room
Solidification room
Drying area
Tray dryer room
Jacketed vessel room
Mixing room
Sifting room
Deep freezing
Fluidised bed dryer
Spray dryer room
Quality Control area-
Chemical lab
Instrumentation lab
Microbiology lab
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ASIAN PHARMA
Introduction -
The plant is situated in Himachal Pradesh which is at the foothills of the Himalayas. It
has clean & green surroundings in the Industrial area promoted by HPSIDC Baddi,
Himachal Pradesh.
Facility for manufacturing of Tablets, Capsules, Cream, Ointments, Gel and Lotion.
Quality unit is independent of manufacturing.
Facility has been catering to Domestic Market requirements.
Products manufactured at this site are for Domestic Market.
Engineering Sciences
Technology Development
Translational Research
Food Protection and Safety
Food Technology being inter-disciplinary in nature the mandate or vision of the Institute is fulfilled
through various R&D Departments and Support Departments along with its Resource Centres at
Hyderabad, Lucknow and Mumbai.
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INSTRUMENTS
There are various instruments which are kept in the ASIAN PHARMA. During our visit our tour
guide showed us various instruments an explained about their instrumentation and applications.
1. Gas Chromatography
The mobile phase which we usually used in gas chromatography is noble gas or an unreactive gas
such as helium, argon, nitrogen, and hydrogen. A sample is injected into a heating block where the
compound is vaporized. Gas chromatography got a boost when gas liquid chromatography was
invented with good instrumentation.
It is used for testing the purity of substances or the separation of a particular component from a
mixture. The success and failure of gas chromatography analysis or separation depend mainly on
the retention time.
1. Pressure regulator
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A sample is injected into a heating block where the compound is readily vaporized.
The sample vapour is carried by the carrier gas into the column inlet.
The solute is absorbed in the head of the column by the stationary phase. It is traveled
at its own rate through the column according to its partition coefficient value.
Solutes are eluted according to their partition coefficient and entered into the detector.
In the detector, solutes give a series of signals resulting from concentration changes
and different rates of elution.
The recorder provides a plot of the time ageist composition of the carrier gas stream.
The peaks of the plot give the quantitative data in the gas chromatogram.
There are two phases in the HPLC system like mobile phase and the stationary phase. We used a
pump to control the flow rate of the mobile phase.
Mobile Phase
The mobile phase in the HPLC system is liquids that dissolved the analyzing samples.
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Stationary Phase
The stationary phase in the HPLC system must be pressure stable. Usually, inorganic supports are
stable at about 600 atmospheric pressure. Silica or alumina is best-bonded support because they
need not be saturated with liquid phase and do not need a precolumn unit. When we used such a
support medium, no contamination from the stationary phase occurred during sample isolation.
The ion exchange phase in the HPLC unit has a limited utility due to its compressibility. Pressure
stable resins are available today which can withstand a pressure of 200 atmospheres. The problems
of stationary supports in exclusion chromatography are more complex than ion exchange resins. All
types of gels used in columns are not pressured stable. Therefore, shrinking under pressure reduces
the efficiency of separation in high-performance liquid chromatography.
Working
The instrumentation of a high performance liquid chromatography unit is given below the picture,
Generally, the efficiency of separation is better at low particle size. Reasonable flow rates in the
HPLC system can be realized by high-pressure pumps. A high performance liquid chromatography
system has the following main components,
Solvent reservoir
Sample injection port
HPLC column
HPLC detectors
HPLC chromatogram
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3. Infrared Spectroscopy
Infrared spectroscopy also called IR spectroscopy or vibrational spectroscopy is the analysis of
infrared light that interacts with matter in the infrared region of the electromagnetic spectrum.
An infrared spectrometer is an instrument based on absorption in the infrared region due to
changes in vibrational energy.
1. Radiation source
2. Sample cells and sampling of substances
3. Monochromators
4. Detectors
5. Recorder
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A pellet mill, also known as a pellet press, is a type of mill or machine press used to create pellets
from powdered material. Pellet mills are unlike grinding mills, in that they combine small materials
into a larger, homogeneous mass, rather than break large materials into smaller pieces.
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The institute has diverse equipment and machineries for pilot production of food products some of it
was developed in-house as well. The same facility can be hired by any SMEs, Entrepreneur’s etc.
for carrying out manufacturing and for introducing new/existing products on a trial basis.The
services provided by the Unit are boon to the small and Medium scale industries and new
entrepreneurs. Major processing units housed in the facility include: Twin crew extrusion
equipment, Cryogenic grinding system, Drying systems, Roasting systems and forming machinery.
Added to it there is a Design Centre and Prototype Fabrication Units while assisting in the
automation demands in the area of food processing. Also various Mini Pilot plants attached to the
technology departments caters to the processing of grains, spices, baking, fruits and vegetables,
Packaging and Meat processing.
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REFERNCES
3.https://www.priyamstudycentre.com/2021/11/gas-chromatography.html [Accessed on 19
April 2023]
4.https://www.priyamstudycentre.com/2021/12/high-performance-liquid-chromatography-hplc.html
[Accessed on 19 April 2023]
5.https://www.priyamstudycentre.com/2022/12/infrared-spectroscopy-ir-
spectrophotometer.html [Accessed on 19 April 2023]
6.https://en.m.wikipedia.org/wiki/Pellet_mill#:~:text=A%20pellet%20mill%2C%20also%20known,
large%20materials%20into%20smaller%20pieces. [Accessed on 20 April 2023]
7. https://www.asianpharma.in/About.html
8. https://www.gmhlaboratories.com/
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CONCLUSION
In the end I am glad to tell you that training in G.M.H PHARMACEUTICALS PVT. LTD. And
ASIAN PHARMA, Baddi, was an excellent and fabulous experience. During the training I actually
learned about the pharmaceutical company and above its working the theoretical knowledge is
worth for getting a degree, and it is accessible in the book.
We can only imagine the thing we read, but practical life is always different and an excellent one.
During my training period, I saw the 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.
Similarly, from a practical point of view a pharmaceutical company is very difficult. During the
training session I tried to my level best to gain practical knowledge as much as I can. I improved my
basic classified doubts and understood the importance of maintaining the quality of products at
pharmaceutical company.
I was successfully able to complete my short venture of training. Lastly, I hope that my training
report fulfils the intended requirements.
-Regards
Shivam Singh
4th Year
B Pharm
(Sem-
8th)