AMRAPALI

GROUP OF INSTITUTES
PROJECT REPORT ON

INDUSTRIAL TRAINING
Agron Remedies | Pharmaceutical Manufacturerand Supplier SARVERKHERA,
KASHIPUR,UTTARAKHAND

PROJECT REPORT SUBMITTED TO AMRAPALI GROUP OF INSTITUTE IN PARTIAL FULFILLMENT

OF THE REQUIREMENT FOR THE AWARD
OF
B.Pharma Degre

By:- Neha

Under the Supervision of Faculty Mrs Sarita Rawat

 DECLARATION

I ,Neha student of B.Pharma 4th Year (7" semester) studying at

Amrapali Group Insitute Siksha Nagar Lamachaur. Hereby declare
that summer training report on Manufacturing of Tablets &Quality
control submitted to amrapali group of institute Siksha Nagar
Lamachaur in fulfillment of degree of pharmacy is the original work
conduct by me. The information and data given in the report is
authentic to the best of my knowledge. this summer training report
is not being submitted to any other institute or University for any
award.

Submitted By- Neha

 ACKNOWLEGMENT

It is a matter of pleasure and happiness to make and submit this industrial training report
during course of the completion of this industrial work. Many of the persons have offered
their valuable and enormous support. m thankful to all my teachers of Amrapali Group of
Institutes. For their blessings and encouragement.

I would like to express my special thanks and gratitude to AGRON REMEDIES P.V.T L.T.D
and Mr. Jitendra Mandola for providing all the essential facilities which were required for
this training.

Neha B.Pharma 4th Year

 INTRODUCTION
Location -Agron Remedies P.V.T L.T.D
Sarverkhera kashipur
244713 Uttarakhand
INDIA
Established in 1986 Agron Remedies Pvt. Ltd. started its operation as a Pharmaceutical
Products manufacturing unit in Uttarakhand, when Pharmaceutical Industry was still a
toddler in India. The manufacturing unit of Agron Remedies was set up at Kashipur, a
beautiful and picturesque town of Uttarakhand. It is around 200KM from Delhi at
National Highway No. 74. The Company is WHO-GMP Certified for all of its
manufacturing section. The manufacturing operation is carried out under supervision of
highly qualified technical staff. The unit has a covered area of 85000 S.F. and land area
of one lakh S.F. Agron has a fully equipped ultra-modern laboratory with all the
sophisticated equipment. Numbers of analytical chemists carry out the testing of products
right from raw material stage to finished products. With a motto to provide "Cure Through
Quality" Agron Remedies is committed to Quality. The company strictly adheres to all the
quality parameters required and consider it integral to all work processes. Agron Remedies
has a total computerized work environment from procurement to dispatch. This makes
Agron Remedies an error free company. The company has in house quality checks that are
carried out at different stages of production.
 OUR MANUFACTURING SECTIONS

. Fully automatic with latest technology injectable plant for Liquid Injectables and vials and
a separate plant for CAPHALOSPORINS Dry Powder Injectables
. Fully automatic with latest technology Ointment manufacturing plant for Aluminum and
Lamitubes, Lotion, Shampoo etc
.Eye drops manufacturing section
.Fully equipped with latest technology tablet manufacturing plant
. Fully automatic Liquid manutacturing plant for syrups and suspensions
. Fully equipped Capsule section for hard gelatin capsules Dry syrup manufacturing
section.
.Beta lactam Section for manufacturing of Tablets, Capsules and Dry Syrups
. We have recently added a big plant for Ayurvedic /Herbal products. It has all sections to
manufacture Ayurvedic /Proprietary /Classical-syrups Capsules. Tablets, Skin preparations
powders, Asavas, Bhasma, Ras, Churna, Soaps etc.
.Section for Nutraceutical Products Soft Gelatin Capsules manufacturing plant with latest
technology.
 OUR MARKETING DIVISIONS

Agron Medica (PCD marketing)

Agrogem Agrovision (PCD marketing)
Agron veterinary division
Agron Ayurveda Ayurmangal- OTC Division

OUR 1200+ PRODUCTS RANGE INCLUDES

Antibiotics/antibacterial/ anti amoebics Nutraceutical Products

NSAID'S/ Anti-Inflammatory/ Analgesics Anthelmintic
Gastro-enterological product Lipid Lowering Agent
Pediatric products Dental Products
Gynecological product Orthopedic/ surgeon products Antiallergic Drugs
Very wide injectables range Antifungal Drugs
Cardiovascular Drugs Antiviral Drugs
Neuro-Psychotropic Drugs Antimalaria
Eye/Ear and Nasal drops Cerebal Activators
Dermatological product Iron & Vitamins Products
Antidiabetic Drugs Impotence Drugs for Erectile Dysfunction
Antiulcer Drugs Ayurvedic/ Herbal products
 WHY AGRON REMEDIES PVT LTD.
Manufacturing of all product in our own state of art plants
Manufacturing of injectables (Beta Lactam and non-Beta lactam), dleis, capsules,
Ointment, Lotions, Liquid orals, Eye/Ear Drops etc.
Have WHO-GMP and ISO-9001:2008 certifications
More than three decades (35 yrs. +) of Manufacturing experience
Very Competitive price with higher margin of profit
Stock Available round the clock -timely service & on time supplies
Elegant packing with unmatched Quality
Long lasting relationship, committed dealings
Road permit not required for supplies from U.P depot and Bihar depot

We are exporting our products to several countries. We undertake third party

manufacturing also. We are manufacturing products for various companies of National and
international repute.
 LIST OF PRODUCTS

1.Bactrim Syrup 2. Becozym C Forte

3. Paraxin Suspension 4. Basiton C forte with Biotin Tablet
 Production Department
Tablets
It is a single unit solid oral dosage form, formed via application of force on the bulk of
powder and excipients in a specified given volume. Tablets may be defined as solid
pharmaceutical dosage form containing drug substances with or without any diluents and
prepared by compression or molding.
Types of Tablets .
Tablet Ingested Orally
Compressed Tablets
Multicompressed Tablets
Repeat Action Tablets
Delayed Action Tablets
Sugar and Chocolate Coated Tablets
Film Coated Tablets
Tablets Used in Oral Cavity
Buccal Tablets
Sublingual Tablets
Troches and Lozenges
Dental Cones
Tablets Used To Prepare Solution.
Effervescent Tablets .
Dispensing Tablets
.Hypodermic Tablets
.Tablet Triturates
Tablets Administered By Other Routes
Implantation Tablets

Advantages
Tablets are simple and convenient to use
Easy to administered and swallow.
Cost is lowest of all oral dosage form.
Best suited to large scale production.

Disadvantages
Difficult to swallow in case of children and unconscious patients.
Drug with poor wetting and slow dissolution properties are difficult to convert into which
provide full drug bioavailability.
Tablets cannot administer in those case i which quick action is required.

Components of Tablets
Active Pharmaceutical Ingredient
Diluents
Glidants
Disintegration agent
Lubricant Wetting agent
 Methods of Tablet Manufacturing

Direct Compression - In this method of tablet preparation all components i.e. Diluents,
disintegrant, glidant and lubricant. This mixture is directly compressed to form tablets.

Dry Granulation - In this method tablets are prepared by mixing diluents and
disintegration. After that this mixture compressed to form big tablets which further
granulated and sieves in granules following addition of disintegrant, glidant and lubricant
and lastly compressed to form tablet.

Wet Granulation - In wet granulation method of tablet preparation diluents and

disintegrant are mixed together in blender with binding solution and dough obtained. This
dough then transfer to the granulator in which small granules forms. Granules, then
screened by sieves and transfer to dryer where they dry. After the drying of granules,
glidant, disintegrant and lubricant introduced to the granules following the compression to
obtain tablets.
 Granulation

It is the part of the pharmaceutical process that attempts to improve the flow of powdered
materials by forming sphere like or regularly shaped aggregates called granules.

Granulation is done to improve the content uniformity, so that better therapeutic effect
could be produced.
Fluidized Bed Dryer
Fluidized bed dryer is a kind of equipment used extensively in the pharmaceutical
industries to reduce the moisture content of pharmaceutical powder and granules. In
fluidization process, hot air is introduced at high pressure through a perforated bed of
moist solid particulate. The wet solids are lifted from the bottom and suspended in a
stream of air (fluidized state Heat transfer S accomplished by direct contact between the
wet solid and hot gases. The vaporized liquid is carried away by the drying gasses.
Sometimes to save energy, the exit gas is partially recycled.

A typical fluidized bed dryer consists of the following components

Air preparatory unit.
Product container
Exhaust filter.
Exhaust blower.
Air distribution plate.
Spray nozzle.
fluidized bed dryer
 Tablet Coating
The formation of an extra layer on the surface of finished and achieve compressed tablet in
order to a specific goal known as tablet coating. The objectives of tablet coating are as
follows:
Primary objective of tablet coating is to mask the taste and odor.
Tablet coating also provide protection to the drug by protecting physical and chemical
damage
To protect the drug from acid present in stomach.
To incorporation another drug adjuvant in the coating two avoid chemical incompatibilities
or to provide drug release.
Types of Tablet Coating
Sugar Coating-Polyvinyl acetate (PVA), polyvinyl pyrrolidone (PVP), carboxymethyl
starch, dextrin, acacia gum, gelatin, agar-agar, sodium alginate and cellulose ethers.
Enteric Coating - Cellulose acetate phthalate, acrylate polymers, hydroxypropyl
methylcellulose phthalate, polyvinyl acetate phthalate ete .
Film Coating- Hydroxypropylmethyl cellulose, ethyl cellulose, methylhydroxyethyl
cellulose, hydroxypropylcellulose, povidone, sodium carboxymethylcellulose, acrylate
polymers etc.

Conventional Coating
 Packaging
Packaging is the art. science and technology of enclosing or protecting products from any
kind of physical and chemical damage lt also can be described as the system involves
prepared material tor transport. storage and providing the patient.

Types of packaging of Tablets

Blister Packaging - This packaging comnmonly used for unit dose packaging. It comprise
of forming film in which product fits and a backing; the lidding foil sticked over the back of
a blister.

Secondary Packaging - This packaging is done to protect the primary packaging generally
used to pack the group of primary packages.
Tertiary Packaging-This packaging is used for bulk handling. warehouse storage and
transport.

Strip Packaging - This packaging is formed by feeding two webs of a heat sealable flexible
film through heated crimping rollers.
Alu Alu packaging - In this packing both sides of packaging are made up of aluminium.
 Quality Control Departmment

In NAAR Pharmaceuticals tlhere is a quality control dopartnent, where executive ensures

the qaty of produet by evalating the products perforning slandard tests. The quality ofl
product evaluation is done in the following three slages:
Stage 1 Finst stage of quality control is when muterial is evalualed.
Stage 2 When all ingredients are mixed together and compressed to form tablet, then it is
called as n Process Qality Control (1PQC). In this sluge product is known as semifinal
product.
Stage 3 Ater packaging the product called as finished product and sent to the quality
control department This is the last slage of quality control of product.
Evaluation of Tablets
Appearance-It is most important quality required for patient compliance and icceptance.
Size and Shape -Size and shape is determines by measuring the dimensions of the tablets
ic. thickness width and length.
Organoleptic Properties- It includes the color and odor. It should be uniform and
acceptable by patient.
Hardness -The ability of' a tablet to withstand for mechanical shocks is called as hardness
It is expressed in kg/em2 and tested by Pfizer hardness tester .

Pfizer hardness tester .

Friability - Friability of the tablets determined by friabilator and friability is cexpressed in
percentage.

Drug Content Uniformity-This test performed by grinding tablet and dissolving in

suitable medium. This stock solution then diluted with the same medium used to prepare
stock solution. After that, the amount of drug was determined by analyzing the solution by
using UV spectrophotometer.
Weight Variation Test- In this test, 20 tablets taken randomly from each batch weighed
and note down the weight of the individual tablet and check for any variation in its weight

In Vitro Disintegration Test - Disintegration is described s the process of breakdown of

tablet into small particles and determined by using disintegration apparatus. In this test
each tablet placed in all tubes of disintegration apparatus then place the disc on the top of
tablet placed n tube which consisting 6.8 ph buffer. The apparatus keeps up and down.
Note down the time taken by tablet.
In Vitro Dissolution - This test is done by using dissolution apparatus. In this test buffer
placed in the dissolution chambers and keep the tablet into it. At the interval of 30 minutes
samples should be taken until drug release does not analyzed 80% of the total amount of
drug.

Dissolution Apparatus

HPLC IR Apparatus
 Learnings

.In Industrial training, I learned about the procedure of working in the company. I learned
the way of filling the documentation part such as BMR form, IPQA form etc.
.In Production Department, I learned about Granulation, way of handling the granulation
equipment and viewed how the granules were formed.
.In Compression, I observed the problems of sticking and picking of tablets during
compression and learned the ways to tackle them.
.During the process of compression, I learned about various operations that were
performed such as weighing of the tablet, calculation of weight variation test, hardness and
diameter was determined, etc.
.After compression of batches, whenever a new batch starts all the compression equipment
as well as the compression area is thoroughly cleaned.
. In IPQC, Disintegration test was performed for 6 tablets, Friability test was performed on
10 tablets and it must be NMT then 1%.
Conclusion

By this Industrial Training, I acquired lots of experiences in pharmaceutical production and

production management. It helped me in knowing the industrial life and comparing my
book knowledge towards industry as well as theoretical knowledge towards practical. I
hope that in near future when 1 have to do the job after completion of my course this
industrial training will help me a lot. It provides me a realistic approach towards my
profession.