A

Project report on
Industrial
"̶ Industrial
IndustrialTraining"
Training "
Submitted to
Dr. A P J Abdul Kalam Technical University-Lucknow

BACHELOR OF PHARMACY
For
Session: 2022-23

Submitted by
Arun Singh (2002340500019)

Under the supervision of

Dr. Raghvendra Sharma
(M. Pharm Ph. D)

ALIGARH COLLEGE OF PHARMACY – ALIGARH

(U.P)
APPROVED BY AICTE, PCI & AFFILATED TO
Dr. A.P.J A.K.T.U –LUCKNOW (U.P)
 ALIGARH COLLEGE OF PHARMACY

DECLARATION BY THE CANDIDATE

I hereby declare that the project work entitled " Industrial Training"
submitted to Dr. A P J Abdul Kalam Technical University,
Lucknow, is a bonafide and genuine work carried out by me
under the guidance of Dr. Raghvendra Sharma . I also declare
that the material embodies in its original and the same has not
previously formed the basis for the award of any diploma, degree,
Fellowship of other university or institution.

DATE : Submitted by:

PLACE : ALIGARH Arun Singh

B .Pharma (3rd Year)

(2002340500019)
 ALIGARH COLLEGE OF PHARMACY

ENDORSEMENT BY THE GUIDE

This is to be certified that project entitled “ Industrial Training” is a
bonafide work done by " Arun Singh " in partial fulfillment of
the requirement for degree of “Bachelor of Pharmacy” of Dr. APJ
Abdul Kalam Technical University, Lucknow. This work was
carried out by his under my guidance and supervision.

DATE: Dr. Raghvendra Sharma

PLACE: ALIGARH (M. Pharm Ph. D )
 ALIGARH COLLEGE OF PHARMACY

ENDORSEMENT BY THE PRINCIPAL

This is to be certified that the project entitled " Industrial Training"
is a bonafide work done by " Arun Singh" .
In Partial Fulfillment of the requirement for degr ee of “Bachelor
of Pharmacy” of Dr. APJ Abdul Kalam Technical University,
Lucknow. This work was carried out by me under him guidance
and Supervision.

DATE: Dr. Raghvendra Sharma

PLACE: ALIGARH (M. Pharm Ph.D. )
 ACKNOWLEDGEMENT

It has my proud privileges to be attached to Aligarh College of

Pharmacy, Aligarh. A highly professionalized college with modern

outlook. I have learned a lot during my training duration and

conation has been fortunate in getting opportunity of studying

college.

I would like to thanks Dr. Raghvendra Sharma, principal of the

College providing necessary facilities and guidance during entire

period of my project.

Arun Singh
 CONTENT

1. HISTORY OF PHARMACEUTICAL INDUSTRY 1

2. LAYOUT OF INDUSTRY 7
3. MACHINES USED IN P. INDUSTRY 11
4. EVALUATION OF PRODUCTS 15
5. PACKAGING OF PRODUCTS 19
6. MARKETING OF PRODUCTS 22
7. CONCLUSION 25
8. REFERENCE 26
 A report on Industrial Training

History of Pharmaceutical Industry

The modern era of the pharmaceutical industry—of isolation and purification of compounds, chemical
synthesis, and computer-aided drug design—is considered to have begun in the 19th century, thousands
of years after intuition and trial and error led humans to believe that plants, animals, and minerals
contained medicinal properties. The unification of research in the 20th century in fields such as
chemistry and physiology increased the understanding of basic drug-discovery processes. Identifying
new drug targets, attaining regulatory approval from government agencies, and refining techniques in
drug discovery and development are among the challenges that face the pharmaceutical industry today.
The continual evolution and advancement of the pharmaceutical industry is fundamental in the control
and elimination of disease around the world.

The origin of medicines

The oldest records of medicinal preparations made from plants, animals, or minerals are those of the
early
Chinese, Hindu, and Mediterranean civilizations. An herbal compendium, said to have been written in the
28th century BC by the legendary emperor Shennong, described the antifever capabilities of a substance
known as chang shan (from the plant species Dichroa febrifuga), which has since been shown to contain
antimalarial alkaloids (alkaline organic chemicals containing nitrogen). Workers at the school of alchemy
that flourished in Alexandria, Egypt, in the 2nd century BC prepared several relatively purified inorganic
chemicals, including lead carbonate, arsenic, and mercury. According to De materia medica, written by the
Greek physician Pedanius Dioscorides in the 1st century AD, verdigris (basic cupric acetate) and cupric
sulfate were prescribed as medicinal agents. While attempts were made to use many of the mineral
preparations as drugs, most proved to be too toxic to be used in this manner.

Many plant-derived medications employed by the ancients are still in use today. Egyptians treated
constipation with senna pods and castor oil and indigestion with peppermint and caraway. Various plants
containing digitalis-like compounds (cardiac stimulants) were employed to treat a number of ailments.
Ancient Chinese physicians employed ma huang, a plant containing ephedrine, for a variety of purposes.
Today ephedrine is used in many pharmaceutical preparations intended for the treatment of cold and
allergy symptoms. The Greek physician Galen (c. 130–c. 200 AD) included opium and squill among the
drugs in his apothecary shop (pharmacy). Today derivatives of opium alkaloids are widely employed for
pain relief, and, while squill was used for a time as a cardiac stimulant, it is better known as a rat poison.
Although many of the medicinal preparations used by Galen are obsolete, he made

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many important conceptual contributions to modern medicine. For example, he was among the first
practitioners to insist on purity for drugs. He also recognized the importance of using the right variety and
age of botanical specimens to be used in making drugs.
Pharmaceutical science in the 16th and 17th centuries

Pharmaceutical science improved markedly in the 16th and 17th centuries. In 1546 the first
pharmacopoeia, or collected list of drugs and medicinal chemicals with directions for making
pharmaceutical preparations, appeared in Nürnberg, Ger. Previous to this time, medical preparations had
varied in concentration and even in constituents. Other pharmacopoeias followed in Basel (1561),
Augsburg (1564), and London (1618). The London Pharmacopoeia became mandatory for the whole of
England and thus became the first example of a national pharmacopoeia. Another important advance was
initiated by Paracelsus, a 16th-century Swiss physician-chemist. He admonished his contemporaries not to
use chemistry as it had widely been employed prior to his time in the speculative science of alchemy and
the making of gold. Instead, Paracelsus advocated the use of chemistry to study the preparation of
medicines.

In London the Society of Apothecaries (pharmacists) was founded in 1617. This marked the emergence of
pharmacy as a distinct and separate entity. The separation of apothecaries from grocers was authorized by
King James I, who also mandated that only a member of the society could keep an apothecary’s shop and
make or sell pharmaceutical preparations. In 1841 the Pharmaceutical Society of Great Britain was
founded. This society oversaw the education and training of pharmacists to assure a scientific basis for the
profession. Today professional societies around the world play a prominent role in supervising the
education and practice of their members.

Isolation and synthesis of compounds

In the 1800s many important compounds were isolated from plants for the first time. About 1804 the
active ingredient, morphine, was isolated from opium. In 1820 quinine (malaria treatment) was
isolated from cinchona bark and colchicine (gout treatment) from autumn crocus. In 1833 atropine
(variety of uses) was purified from Atropa belladonna, and in 1860 cocaine (local anesthetic) was isolated
from coca leaves. Isolation and purification of these medicinal compounds was of tremendous importance
for several reasons. First, accurate doses of the drugs could be administered, something that had not been
possible previously because the plants contained unknown and variable amounts of the active drug.
Second, toxic effects due to impurities in the plant products could be eliminated if only the pure active

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ingredients were used. Finally, knowledge of the chemical structure of pure drugs enabled laboratory
synthesis of many structurally related compounds and the development of valuable drugs.
Pain relief has been an important goal of medicine development for millennia. Prior to the mid-19th
century, surgeons took great pride in the speed with which they could complete a surgical procedure.
Faster surgery meant that the patient would undergo the excruciating pain for shorter periods of time. In
1842 ether was first employed as an anesthetic during surgery, and chloroform followed soon after in
1847. These agents revolutionized the practice of surgery. After their introduction, careful attention could
be paid to prevention of tissue damage, and longer and more-complex surgical procedures could be
carried out more safely. Although both ether and chloroform were employed in anesthesia for more than
a century, their current use is severely limited by their side effects; ether is very flammable and explosive
and chloroform may cause severe liver toxicity in some patients. However, because pharmaceutical
chemists knew the chemical structures of these two anesthetics, they were able to synthesize newer
anesthetics, which have many chemical similarities with ether and chloroform but do not burn or cause
liver toxicity.

The development of anti-infective agents

Discovery of antiseptics and vaccines

Prior to the development of anesthesia, many patients succumbed to the pain and stress of surgery.
Many other patients had their wounds become infected and died as a result of their infection. In 1865 the
British surgeon and medical scientist Joseph Lister initiated the era of antiseptic surgery in England. While
many of the innovations of the antiseptic era are procedural (use of gloves and other sterile procedures),
Lister also introduced the use of phenol as an anti-infective agent. In the prevention of infectious diseases,
an even more important innovation took place near the beginning of the 19th century with the
introduction of smallpox vaccine. In the late 1790s the English surgeon Edward Jenner observed that
milkmaids who had been infected with the relatively benign cowpox virus were protected against the
much more deadly smallpox. After this observation he developed an immunization procedure based on
the use of crude material from the cowpox lesions. This success was followed in 1885 by the development
of rabies vaccine by the French chemist and microbiologist Louis Pasteur. Widespread vaccination
programs have dramatically reduced the incidence of many infectious diseases that once were common.
Indeed, vaccination programs have eliminated smallpox infections. The virus no longer exists in the wild,
and, unless it is reintroduced from caches of smallpox virus held in laboratories in the United States and

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Russia, smallpox will no longer occur in humans. A similar effort is under way with widespread polio
vaccinations; however, it remains unknown whether the vaccines will eliminate polio as a human disease.
Improvement in drug administration

While it may seem obvious today, it was not always clearly understood that medications must be
delivered to the diseased tissue in order to be effective. Indeed, at times apothecaries made pills that
were designed to be swallowed, pass through the gastrointestinal tract, be retrieved from the stool, and
used again. While most drugs are effective and safe when taken orally, some are not reliably absorbed
into the body from the gastrointestinal tract and must be delivered by other routes. In the middle of the
17th century, Richard Lower and Christopher Wren, working at the University of Oxford, demonstrated
that drugs could be injected into the bloodstream of dogs using a hollow quill. In 1853 the French surgeon
Charles Gabriel Pravaz invented the hollow hypodermic needle, which was first used in the treatment of
disease in the same year by Scottish physician Alexander Wood. The hollow hypodermic needle had a
tremendous influence on drug administration. Because drugs could be injected directly into the
bloodstream, rapid and dependable drug action became more readily producible. Development of the
hollow hypodermic needle also led to an understanding that drugs could be administered by multiple
routes and was of great significance for the development of the modern science of pharmaceutics, or
dosage form development.

Drug development in the 19th and 20th centuries

New classes of pharmaceuticals

In the latter part of the 19th century a number of important new classes of pharmaceuticals were
developed. In 1869 chloral hydrate became the first synthetic sedative-hypnotic (sleep-producing) drug. In
1879 it was discovered that organic nitrates such as nitroglycerin could relax blood vessels, eventually
leading to the use of these organic nitrates in the treatment of heart problems. In 1875 several salts of
salicylic acid were developed for their antipyretic (fever-reducing) action. Salicylate-like preparations in
the form of willow bark extracts (which contain salicin) had been in use for at least 100 years prior to the
identification and synthesis of the purified compounds. In 1879 the artificial sweetener saccharin was
introduced. In 1886 acetanilide, the first analgesic-antipyretic drug (relieving pain and fever), was
introduced, but later, in 1887, it was replaced by the less toxic phenacetin. In 1899 aspirin (acetylsalicylic
acid) became the most effective and popular anti-inflammatory, analgesic-antipyretic drug for at least the
next 60 years. Cocaine, derived from the coca leaf, was the only known local anesthetic until

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about 1900, when the synthetic compound benzocaine was introduced. Benzocaine was the first of
many local anesthetics with similar chemical structures and led to the synthesis and introduction of a
variety of compounds with more efficacy and less toxicity.
Discovery of Penicillin

The first description of penicillin was published in 1929 by the Scottish bacteriologist Alexander Fleming.
Fleming had been studying staphylococcal bacteria in the laboratory at St. Mary’s Hospital in London. He
noticed that a mold had contaminated one of his cultures, causing the bacteria in its vicinity to undergo
lysis (membrane rupture) and die. Since the mold was from the genus Penicillium, Fleming named the
active antibacterial substance penicillin. At first the significance of Fleming’s discovery was not widely
recognized. It was more than 10 years later before British biochemist Ernst Boris Chain and Australian
pathologist Howard Florey, working at the University of Oxford, showed that a crude penicillin preparation
produced a dramatic curative effect when administered to mice with streptococcal infections. The
production of large quantities of penicillin was difficult with the facilities available to the investigators.
However, by 1941 they had enough penicillin to carry out a clinical trial in several patients with severe
staphylococcal and streptococcal infections. The effects of penicillin were remarkable, although there was
not enough drug available to save the lives of all the patients in the trial.

In an effort to develop large quantities of penicillin, the collaboration of scientists at the United States
Department of Agriculture’s Northern Regional Research Laboratories in Peoria, Ill., was enlisted. The
laboratories in Peoria had large fermentation vats that could be used in an attempt to grow an abundance
of the mold. In England the first penicillin had been produced by growing the Penicillium notatum mold in
small containers. However, P. notatum would not grow well in the large fermentation vats available in
Peoria, so scientists from the laboratories searched for another strain of Penicillium. Eventually a strain of
Penicillium chrysogenum that had been isolated from an overripe cantaloupe was found to grow very well
in the deep culture vats. After the process of growing the penicillin-producing organisms was developed,
pharmaceutical firms were recruited to further develop and market the drug for clinical use. The use of
penicillin very quickly revolutionized the treatment of serious bacterial infections. The discovery,
development, and marketing of penicillin provides an excellent example of the beneficial collaborative
interaction of not-for-profit researchers and the pharmaceutical industry.

Discovery and development of hormones and vitamins

Isolation of insulin

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The vast majority of hormones were identified, had their biological activity defined, and were synthesized
in the first half of the 20th century. Illnesses relating to their excess or deficiency were also beginning to
be understood at that time. Hormones, produced in specific organs, released into the circulation, and
carried to other organs, significantly affect metabolism and homeostasis. Some examples of hormones
are insulin (from the pancreas), epinephrine (or adrenaline; from the adrenal medulla), thyroxine (from
the thyroid gland), cortisol (from the adrenal cortex), estrogen (from the ovaries), and testosterone (from
the testes). As a result of discovering these hormones and their mechanisms of action in the body, it
became possible to treat illnesses of deficiency or excess effectively. The discovery and use of insulin to
treat diabetes is an example of these developments.

Identification of vitamins

Vitamins are organic compounds that are necessary for body metabolism and, generally, must be
provided from the diet. For centuries many diseases of dietary deficiency had been recognized, although
not well defined. Most of the vitamin deficiency disorders were biochemically and physiologically defined
in the late 19th and early 20th centuries. The discovery of thiamin (vitamin B1) exemplifies how vitamin
deficiencies and their treatment were discovered.

Thiamin deficiency produces beriberi, a word from the Sinhalese meaning “extreme weakness.” The
symptoms include spasms and rigidity of the legs, possible paralysis of a limb, personality disturbances,
and depression. This disease became widespread in Asia in the 19th century because steam-powered rice
mills produced polished rice, which lacked the vitamin-rich husk. A dietary deficiency was first suggested
as the cause of beriberi in 1880 when a new diet was instituted for the Japanese navy. When fish, meat,
barley, and vegetables were added to the sailor’s diet of polished rice, the incidence of beriberi in the navy
was significantly reduced. In 1897 the Dutch physician Christiaan Eijkman was working in Java when he
showed that fowl fed a diet of polished rice developed symptoms similar to beriberi. He was also able to
demonstrate that unpolished rice in the diet prevented and cured the symptoms in fowl and humans. By
1912 a highly concentrated extract of the active ingredient was prepared by the Polish biochemist Casimir
Funk, who recognized that it belonged to a new class of essential foods called vitamins. Thiamin was
isolated in 1926 and its chemical structure determined in 1936. The chemical structures of the other
vitamins were determined prior to 1940.

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Layout of Industry

Pharmaceutical plant layout/ factory layout refers to the allocation of space and the arrangement of
machines, furniture and other important administration and necessary services needed in a production
process within a factory building in other to perform the various unit operations involved in the
manufacturing process of dosage forms in a cost effective manner and with the least amount of handling
in processing the product from the receipt of raw material through the distribution of the finished
product.

 Features/ Characterstics of a good pharmaceutical plant layout

A good pharmaceutical plant layout should possess the following characteristics:

• There should be adequate floor space for machines installation and utilization

• The machines should be properly arranged to facilitate minimum material handling is necessary for
low cost processing.

• The layout should facilitate smooth and continuous flow of production process from one point to
another without any form of delay

• It must incorporate adequate health, safety and security features such as first aid box, fire
extinguisher, emergency exit and access point

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• A good layout should allow effective supervision, coordination and control of the production
processes

• There should be room for adjustment and modifications whenever the need arises.

 Objectives of good pharmaceutical plant layout

If a layout is to fulfill the goal of an organization and to maximize production, it should be planned with
the following objectives in mind:

1. Economy in materials handling

Economy in handling of materials, work-in-progress and finished stock.

2. Optimum utilization of resources

Ensuring optimum utilization of men, materials, equipment and space available.

3. Better inventory control

Minimizing work-in-process and maximizing inventory turnover. The material should move rapidly
through the plant and the points of congestion should be eliminated to have low levels of inventory.

4. Good work flow

Minimizing chances of delay and eliminating bottlenecks in the production system. Ensure a good work-
flow avoiding accumulation of work at vital points.

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5. Efficient control
Good plant layout ensures efficient supervision and production control in an organization.
6. Avoidance of changes
Avoiding frequent changes so that production programme is not upset, causing the cost of production to
rise.

7. Safety
Ensuring safety for the workers by eliminating or at least minimizing the chances of accidents.

8. Better services
Providing adequate service centres at convenient locations.

9. Higher morale
Boosting up employee’s morale by providing incentives and also comforts while at work.

10. Flexibility
Ensuring flexibility of layout for future changes and requirements.

The above objectives of plant layout are laudable in themselves, but it is often difficult to reconcile all of
them in a practical situation. As such, a highest level of skill and judgement are required to be exercised by
a management executive. To achieve this, a close coordination between him and the production manager
is very essential.

 Advantages of a good layout

The advantages of a good layout can be studied from the stand point of the worker, labour cost, other
manufacturing costs, production control, supervision, and capital investment.

A. Advantages of layout to worker

1. Reduction in the effort of the worker.

2. Fewer material handling operations.

3. Extension of the process of specialization.

4. Ensuring maximum efficiency.

5. Better working condition and reduction in the number of accidents.

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B. Advantages of layout in labour costs

1. Reduction in the number of workers.

2. Increase in production per-man-hour.

3. Reduction in the length of haul.

4. Minimum lost motions between operations.

C. Advantages of layout in other manufacturing costs

1. Maintenance and tool replacement costs are reduced.

2. Spoilage and scrap is minimized.

3. Greater saving in the waste of raw material consumption.

4. Improved quality of product due to reduction in the number of handling.

5. Saving motive power.

6. Effective cost control.

D. Advantages of layout in production control

1. Provision of adequate and convenient storage facilities.

2. Better conditions for receipts, shipment and delivery.

3. Increased pace for production.

4. Achievement of production targets unfailingly.

5. Reduction in the number of stock-chasers who are employed to get the work done on time.

E. Advantages of layout in supervision

1. Helps in easing the burden of supervision.

2. Reduces the level of inspection and this minimizing the cost of inspection.

F. Advantages of layout in capital investment

1. Investment in machinery and equipment is reduced because of

 increase in production per machine

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 utilization of idle machine time and

 reduction in the number of operations per machine

2. Permanent investment is kept at the minimum.

3. Floor space and shop areas required for manufacturing are reduced.
Machines used in pharmaceutival industry 1) Granulation Section
Mass Mixer
Mass Mixer is designed to perform smooth operations for thorough mixing equipped with safety
transparent dust cover & specially designed self-adjusting sealing arrangement, which ensures the
restriction of black particles enter the mixing drum. Mass Mixer is Ideal for dry & wet uniform mixing of
materials. Mass Mixer is available in sizes ranging from 5 Kg to 300 Kg as per GMP & cGMP models.

Tray Dryer
A dryer used for drying of the wet products like crude drugs, chemicals, powders or the granules, etc. is
known as Tray dryer. The material which we want to dry is dispersed on the tiers of the trays. The tray,
which is used in this process must have perforated, solid or wire mesh bottoms. For the circulation of the
air across the drying materials, we lined the screen trays with paper. A limited amount of heat is provided
to every shelf at that time when the wind passes over it to provide the latent heat of vaporization. This
kind of dryers provides proper control of humidity and temperature.

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FBD (Fluidized Bed Dryer)

Fluidized (fluid) bed dryers are used extensively in the pharmaceutical industries to reduce moisture
content of pharmaceutical powder and granules. They have also found use in the drying of suspension,
slurries, solutions, dilute paste or sludges. In fluidized bed dryer, hot air is passed at high pressure through
a perforated bottom of the container containing the wet solids. The wet solids are lifted from the bottom
and suspended in a stream of air (fluidized state). The hot air then surrounds every granules. Heat transfer
is accomplished by direct contact between the wet solid and hot gases. The vaporized liquid is carried
away by the drying gasses.

2) Compression Section
Tablet compression machine makes the tablets by pressing the granules in die with lower and upper
punch. Different innovations to tablet compression machines are being done to improve the production
rates and now it is possible to produce more than 500,000 tablets per hour. A tablet formation takes place
by the combined pressing action of two punches and a die.

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3) PACKAGING SECTION
ALU-ALU Packing
Ideal for products that need packaging between two sheets of aluminium foil, such as candies, foodstuff,
tablets and pills. The equipment is able to operate without light, and therefore meets the requirement for
sensitive products that are cannot tolerate exposure to light.

Blister Packing
This machine is ideal for packaging pharmaceutical materials in blister packs that use materials such as
polyvinyl chloride, polystyrene and polypropylene.

• The vibration feeder and crisp remover can remove the powder and crisps inside medicine
effectively.
• Horizontal perforation.

• Auto-counting slitting waster-side cutting.

• Automatically prints batch number.

• The diameter of the heat pressing cam can be modify from 110 to 140mm.

Strip Packing
A high-speed machine that is ideal for different products such as tablets or capsules. Machines are robust
and well constructed and generally provide high quality by using accurate temperature control, and the
ability to exert variable pressure on the sealing rollers. A strip packaging machine is ideal for coating heat
sealable films such as polymer- coated aluminium foil, and polymer-coated paper.

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4) TESTING SECTION

Friability Tester
Friability testing is a method, which is employed to determine physical strength of uncoated tablets upon
exposure to mechanical shock and attrition. In this test 20 tablets are used, the rotation is 25 RPM per
minutes and is done for 4 minutes. The tablets fall down from 6 inches height.The % weight loss should
not be more than 1%.
Percentage Friability = W1 – W2/W1 × 100
Where, W1 = weight of tablets before testing W2 = weight of tablets after testing.

Hardness Tester
Tablet hardness testing is a kind of laboratory technique, which is employed to test breaking point of a
tablet. For pharmaceutical units this process is an important part of medicine production that ensures
tablets must be hard enough to withstand mechanical stress during various conditions such as storage and
packaging, transportation and handling by the consumer etc.

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Dissolution Test
A dissolution test is a means of identifying and proving the availability of active pharmaceutical ingredient
(API) in their delivered form. A dissolution test reflect the availability of active substance and allows the
prediction of the time for complete release of the material from the dosage form. There are many kinds of
dosage forms of course and all of them have a dissolution rate. The dissolution time can range from
seconds to hours or even days for implants according to IP, BP & USP to the specified drugs.

Evaluation of Products
Evaluation of Tablets
 General Appearance:
• The general appearance of a tablet, its identity, and general elegance is essential for consumer
acceptance, for control of lot-to-lot uniformity and tablet-to-tablet uniformity.
• The control of general appearance involves the measurement of size, shape, color, presence or
absence of odor, taste etc.

 Size & Shape:

• It can be dimensionally described & controlled.
• The thickness of a tablet is only variables.
• Tablet thickness can be measured by micrometre or by another device.
• Tablet thickness should be controlled within a ± 5% variation of standard value.

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 Unique identification marking:

• These markings utilize some form of embossing, engraving or printing.
• These markings include company name or symbol, product code, product name etc.

 Organoleptic properties:
• Color distribution must be uniform with no mottling.
• For visual color comparison compare the color of sample against standard color.
• The presence of odor in a batch of tablet indicates a stability problem such as the characteristics
odor of acetic acid in an aspirin tablet.
• The presence of odor could be characteristic of the drug (Vitamin), added ingredients (flavoring
agent) or the dosage form (film-coated tablet have a characteristic odor).
• For chewable tablet presence or absence of specified taste can be checked.
• A tablet level of flaws such s chip, cracks, contamination from foreign solid substances (hair, drops
of oil, dirt), surface texture (smooth vs rough) and appearance (shining vs dull) may have zero
defect.

 Hardness and Friability:

• Tablet requires a certain amount of strength or hardness and resistance to friability to withstand
mechanical shakes of handling in the manufacture, packaging, and shipping.
• Hardness generally measures the tablet crushing strength.
• The strength of a tablet was determined by following ways;
nd rd
• By cracking the tablet between 2 and 3 fingers with the thumb acting as a fulcrum. If there is a

sharp snap, the tablet is an acceptable strength.

• Tablet hardness can be defined as the force required breaking a tablet in a diametric compression.
• In this test the tablet is placed between two anvils, force is applied to the anvils, and the crushing
strength that just causes the tablet to break is recorded.
• Hardness for a compressed tablet is 5 to 8 kg.
• Friability of a tablet can determine in the laboratory by Roche friabilator.
• This consist of a plastic chamber that revolves at 25 rpm, dropping the tablets through a Distance of
six inches in the friabilator, which is then operated for 100 revolutions.
• The tablets are reweighed.
• The compressed tablet that loses less than 0.5 to 1.0 % of the Tablet weight are considered
acceptable.

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 Weight Variation test (U.S.P.):

• Take 20 tablets and weighed individually.
• Calculate average weight and compare the individual tablet weight to the average.
• The tablet pass the U.S.P. test if no more that 2 tablets are outside the percentage limit and if no
tablet differs by more than 2 times the percentage limit.

 Content Uniformity Test:

• Randomly select 30 tablets.
• 10 of these assayed individually.
• The Tablet passes the test if 9 of the 10 tablets must contain not less than 85% and not more than
115% of the labeled drug content and the 10th tablet may not contain less than 75% and more
than 125% of the labeled content.
• If these conditions are not met, remaining 20 tablet assayed individually and none may fall out side
of the 85 to 115% range.

Evaluation of capsules
 Permeability and sealing
Soft gelatin capsules are tested for physical integrity (absence of leakage) by visual inspection. Similarly,
hard gelatin capsules are tested for any breach of physical integrity (breakage or opened cap and body).
 Potency and impurity content

All capsules are tested for drug content (potency, as a percent of label claim). In addition, most drug
products are tested for the related substances or impuri-ties. These must meet predefined specifications
for a batch to be acceptable.

 Average weight and weight variation

Ten hard gelatin capsules are usually weighed individually and the con-tents are removed. The emptied
shells are individually weighed and the net weight of the contents is calculated by subtraction. The
content of active ingredient in each capsule may be determined by calculation based on the percent drug
content in the formulation for high drug load formulations.

 Disintegration

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Disintegration of hard and soft gelatin capsules is evaluated to ensure that the drug substance is fully
available for dissolution and absorption from the GI tract. The disintegration media varies depending on
the type of capsules to be tested.

 Dissolution

Drug absorption and physiological availability depend on the drug sub-stance being in the dissolved state
at the site of drug absorption, viz. the GI fluids. The rate and extent of dissolution of the drug from the
capsule dosage form is tested by a dissolution test. Dissolution test provides means of quality control in
ensuring that (a) different batches of the drug prod-uct have similar drug release characteristics and (b)
that a given batch has similar dissolution as the batch of capsules that was shown initially to be clinically
effective.

 Moisture content

Water content of the entire capsule or the capsule contents are determined by Karl Fisher titrimetry to
enable the correlation of water content with the degradation profile or drug-release characteristics of
capsules.

 Microbial content

The capsules are tested to ensure lack of growth of bacteria and mold by microbiological tests. These
tests are usually carried out by incubation of the capsule contents in a growth medium and counting the
colonies formed after a predefined period of time. Selection of the growth medium and duration of the
test, as well as maintenance of aseptic conditions during the testing, are critical to successful assessment
of microbial contamination by this method.

Evaluation of Parentrals

Evaluation of Parenteral Preparations

1. Sterility test

• Membrane filter method

• Direct inoculation method

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2. Pyrogen test

• LAL Test

• In vivo Rabbit test

3. Clarity test/Foreign particulate matter test

4. Leakage test

5. Isotonicity

6. Content uniformity & Weight

7. Extractable Volume

Packaging of Products
Pharmaceutical packaging (or drug packaging) is the packages and the packaging processes
for pharmaceutical preparations. It involves all of the operations from production through drug
distribution channels to the end consumer.

Pharmaceutical packaging is highly regulated but with some variation in the details, depending on the
country of origin or the region. Several common factors can include: assurance of patient safety,

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assurance of the efficacy of the drug through the intended shelf life, uniformity of the drug through
different production lots, thorough documentation of all materials and processes, control of possible
migration of packaging components into the drug, control of degradation of the drug by oxygen, moisture,
heat, etc., prevention of microbial contamination, sterility, etc. Packaging is often involved in dispensing,
dosing, and use of the pharmaceutical product. Communication of proper use and cautionary labels are
also regulated. Packaging is an integral part of pharmaceutical product.

Packaging is the science, art and technology of enclosing or protecting products for distribution, storage,
sale, and use. Packaging also refers to the process of design, evaluation, and production of packages.
Pharmaceutical packaging can be defined as the economical means of providing presentation, protection,
identification , information, convenience, compliance , integrity and stability of the product .

Types of Packaging

 Primary Packaging
Also known as sales packaging, primary packaging is significant for pharma companies. This packaging is in
direct contact with drugs and medicines. Therefore, the packaging needs to be inert and should not cause
any alteration to the salt in the dosage. If the primary packaging is not done correctly, it may affect the
drug, and you won’t be sure about the medicine quality and its purity.

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The material used for primary packaging must be neutral to ensure it doesn’t interact with the
pharmaceutical product during its entire life. However, if the packaging fails, the drug may become life-
threatening for the patients who may consume it.

The most common material used for primary packaging includes non-reactive substances, like aluminium
and PVC. Likewise, high-quality plastic is used for liquid doses instead of glass. This ensures that the
products don’t spill or get damaged during transportation from the factory to the pharmacy. The most
common plastics used for tablets and pills include polyethylene, polyvinyl chloride, nylon, polycarbonate,
and polyethylene terephthalate.

Different Types of Primary Packaging

The primary packaging consists of packaging material that is in direct contact with the drugs. The
different types of primary packaging for pharmaceutical products are as follows:

BLISTER PACKS
Blister pack is the most common pharmaceutical packaging used to hold solid medicines in place. These
are pre-formed foil, paper, or plastic packs. Blister packs have a pocket or cavity made from
thermoformed plastic. At its backside, there is a paperboard, aluminium foil, or plastic film seal that can be
easily punctured by hand. Notably, this seal includes all the important information related to the drug.

STRIP PACKAGING
It is a unit packing dosage and is specifically used to increase the dosage life as it protects the content
individually. The most significant difference between blister and strip packaging is that strip doesn’t have
thermo-formed cavities. Instead, the packaging is formed around the tablet.

AMPOULES
An ampoule is a small glass or plastic container used for packaging liquid drugs and medicines. These are
sealed vials generally used to protect drugs from the air and other contamination. They are sealed by
melting the top with flame. Notably, glass ampoules are expensive when compared to other types of
packaging.
VIALS
Vials are plastic, or glass containers specifically used to hold solid, powder, and liquid drugs. They are
bigger in size and capacity compared to ampoules. The vials are closed with crimp vials (rubber stopper or

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metal cap), screw vials (screw cap or dropper), or lip vials (plastic stopper or cork). However, plastic vials
have different closure systems - hinge caps - which can be easily closed when pressed. The bottoms of the
vials are mostly flat.

BOTTLES
Most frequently used to carry liquid drugs as well as capsules and formed tablets. Because of excellent
properties, glass bottles are most commonly used for liquid doses. And plastic bottles are used for tablets
and capsules. Although they come in different colours, the most common is brown and orange as they can
prevent ultraviolet light from harming photosensitive contents.

SACHET PACKAGING
Sachet packaging is a pouch packaging made of plastic for separate doses. Mostly they are used for
powder- based medicines. But they can also be used for liquid doses. Sachet packaging can be both single-
use as well as resealable.

 Secondary Packaging
Once the primary packaging is done, it is the time for the packaging that is called secondary packaging. It
is just another layer of packaging which can be any printed material, like
boxes. All the important information is printed on these boxes, like ingredients, manufacturer’s name,
address, warning, and type of medicine. The printed information helps the manufacturer to distinguish
between different boxes with different drugs easily. The secondary packaging essentially gives the drugs a
brand image at the same time, further protects them during transportation.

 Tertiary Packaging
The last type of packaging, i.e. tertiary packaging, is important for the shipping process. The end
consumers don’t see this packaging. The retailers often remove them before they showcase the medicines
in their shops or clinics.

The main objective of tertiary packaging is safeguarding primary and secondary packaging from the
external environment during storage and transportation. The most popular pharma product tertiary
packaging are plane boxes, cardboards, and shrink wraps.

Marketing of Products

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Pharma marketing refers to the marketing of drugs and medical devices by private and public
organizations to doctors, clinicians and consumers. With the average American spending $1,000 on drugs
a year, marketing is a top priority for the major players in the pharmaceutical industry. With so much
spending involved, most companies understand the great role and importance of marketing in pharma.
Marketing is now the key driving force behind shareholder value. More specifically, marketing enables
pharma companies to identify, anticipate and provide solutions for customer requirements.At the same
time, marketing is not always seen as a priority for pharma CEOs which is why professional marketers are
often required to take responsibility for pharma branding and for the ROI on investment.

While many people continue to view pharmaceuticals as commodities, marketers know that branding is
the only way to help differentiate these companies from each other.In this article, we take a look at
pharma marketing and what enables some pharma companies to stand out from the crowd.

Marketing strategies

1. MARKET/PRODUCT DEVELOPMENT STRATEGY

A product/market development strategy concerns developing new products or modifying existing

products and offering those products to current or new markets. These strategies typically surface when
there is little opportunity for growth in an organisation's existing market.Your pharmaceutical product or
service will be promoted in accordance with the Ansoff Matrix almost every time and can dictate the
marketing strategy you will adopt. For example, we see so many partnerships and mergers in this industry,
where pharmaceutical organisations combine their resources and leverage their strengths to increase
market share in this manner.

2. REVENUE STRATEGY

A revenue model strategy (or more casually, a business strategy) is a strategy usually focused on forming
a product or service whereby advertising or licencing revenue can be generated subsequently, or more
broadly, a strategy focused on generating revenue. Magazines and publications follow this strategy, albeit
on different levels where a customer-base is usually built to be leveraged. In this case, the editorial team is
commissioned to write content that is packaged into a printed publication, as well as for an online
audience that can subscribe, that is then used to drive advertising revenue from organisations that wish to
advertise to this audience

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Affiliate marketing

Affiliate marketing - a type of performance-based marketing in which a business rewards one or more
affiliates for each visitor or customer brought by the affiliate's own marketing efforts - broadly falls within
this category. This is the case as an affiliate program’s sole purpose is to sell products with minimal
marketing spend waste as affiliates are paid on a per-sale basis.

Email marketing and list building

Organisations that rent assets and inventories fall within this category, and email marketing has become
a popular channel in this respect. Organisations can rent email lists (for a price) so that other organisations
can sell their products to the subscribers within that email list. This is an interesting concept as, for the
most part, the owner of the email list will not sell its own services to its own list.

3. TARGET MARKETING STRATEGY

Every pharmaceutical marketing strategy will involve an element of targeting. Targeting enables
organisations to narrow their focus and aim marketing campaigns and messages at a specific segment of
the market, thus becoming more relevant to the audience and increasing the chances of conversion into a
customer or client. Essentially focusing on customers that an organisation can serve best.

Market segmentation

Markets consist of various demographic characteristics, needs and behaviours, therefore

products/services and marketing messages may not relate to all of these people. So, strategic
segmentation provides an opportunity to target specific messages and campaigns towards specific
audiences. Creating buyer personas is a great way to start the process, as you will immediately understand
the audience(s) which you are targeting to tailor your content towards. Lifecycle targeting is also another
option to consider, which can be done by targeting content at your audiences during specific stages of the
buyer’s journey.

Product and service positioning

Although it’s sometimes normal that a competitor’s product and service offering differs online versus
offline, it is often that an organisation’s overall offering is very similar to that of a competitor’s. With this

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in mind, positioning your products/services, organisation and brand - and giving it its own USP - can be the
differentiation that tips offering as the most desired solution from the competition.
4. POSITIONING AND DIFFERENTIATION STRATEGY

The section above briefly touches on positioning and differentiation in the context of segments and
submarkets - elements concerned with the customer. This strategy, on the other hand, assumes that the
organisation’s marketing strategy indeed takes into account the customer’s perception of the offering but
relative to those of the competition.

Organisations can position their products and services according to four variables: Product quality,
service quality, price and fulfilment time. Reviewing your internal strengths and comparing them to those
of your competitors, a differentiation strategy that positions your offering above those of your
competitors can be achieved giving the organisation a competitive advantage.

Brand development

Branding is how organisations are perceived in the minds of the audience. Organisations can differentiate
themselves from the competition with a brand strategy. More than simply a name, term, design, or
symbol, a brand is the recognisable feeling a product or business evokes. Brand management begins with
an analysis of how a brand is currently perceived in the market and then proceeds to plan how the brand
should be perceived if it is to achieve its objectives.

Online/offline value proposition

A value proposition is not just a statement of the benefits of the products and services to reinforce the
core proposition to differentiate it from the competitors. It also acts as a driver for developing content and
communicating messages that will strategically fit with its indented audience, providing a direction for all
marketing messages.

5. CUSTOMER ENGAGEMENT STRATEGY

A popular strategy, that one way or another, most companies will adopt. The strategy aims to create
compelling content and experiences and encourages interaction and participation.

With the development of technologies and the growth of marketing platforms and channels, a customer
engagement strategy is highly common for most B2C organisations, as well as B2B brands who are looking

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for a two-way dialogue with their audiences. This is certainly the case for us here at Orientation
Marketing. The aim here is to develop a community around the brand whereby audiences can interact
with certain content.
Social media strategy

Social media platforms provide an audience of highly engaged people, who can be targeted both
organically and via paid means to help achieve marketing objectives. The scope of social media
optimisation also includes the incorporation of features such as sharing and commenting off of social
media platforms and on company websites. Such a strategy can incorporate all of or a range of networks,
such as Twitter, LinkedIn, Facebook and Instagram, to only adopting just one which is most frequently
used by your particular audience.

6. MULTI-CHANNEL STRATEGIES

A multi-channel marketing communications strategy reviews the different types of customer contact with
an organisation to then determine how these touchpoints can be incorporated within a marketing plan to
reach objectives. This strategy involves both online and offline channels and can connect outbound call
with a website and email, for example.

Multi-channels strategies derive from an internal audit to determine customer channel preferences as
well as the preferences of the organisation usually based on internal processes. Pharmaceutical
organisations are required to consider many elements of the strategy, such as customer insight, the
experience as well as its internal capability when adopting multi-channel strategies.

Two common marketing strategies that pharmaceutical organisations can broadly adopt arise from this
sort of strategy.

Customer acquisition strategy

A customer acquisition strategy defines the best mix of media and engagement tools (lead generation
and product offers) to gain new customers by targeting them and reaching them through online and
offline customer journeys. This strategy involves a marketing focus of generating new business leads and
customers, often in the form of inbound sales-related enquiries. An essential component for most
organisations.

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Customer retention strategy

A customer retention strategy focuses less on generating new customers and focuses more on keeping
current customers - customers who you’ve already invested in and earned - happy, loyal and buying from
you. This might include delivering service that’s consistent with your value proposition and brand or cross-
selling, up-selling, asking for referrals from existing customers and developing programmes that increase
customer loyalty. Customer services teams are in place for this very reason.

CONCLUSION

During Industrial training, I gain a lot of experience, knowledge and exposure. All disclosures were awaken
myself in a boost of self- confidence to face life more challenging now. Practical is a complement to the
science or theory learned. This is clearly the concept of science and charity, where they have learned
without practice will be lost and will not give anything.

During my industrial tour, there are many changes from the point of learning environments and
discussion among colleagues. It can directly increase the dedication and rational attitude toward myself.
However, there are still some weaknesses that can be improved in the future.

Therefore I conclude that the industrial training program has provided many benefits to students even if
there are minor flaws that are somewhat disfiguring condition , so that this weakness can be rectified in
the future.

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REFERENCES

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 Soroka, W. Illustrated Glossary of Packaging Terminology (Second ed.). Institute of Packaging

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 Mogull SA (2008). "Chronology of Direct-to-Consumer Advertising Regulation in the United

States". AMWA Journal. 23: 3.

 "BBC News - Pharmaceutical industry gets high on fat profits". BBC News. 19 November 2014.
Archived from the original on 19 November 2014. Retrieved 28 April 2021.

 "Do Biopharma Companies Really Spend More on Marketing Than R&D?". www.raps.org.
Retrieved 28 April 2021.

 Barfett J, Lanting B, Lee J, Lee M, Ng V, Simkhovitch P (2004). "Pharmaceutical marketing to

medical students: the student perspective" (PDF). McGill Journal of Medicine. 8 (1): 21–27.
Archived from the original (PDF) on 27 September 2011.

 Allen L. and Ansel H. (2014). Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems.
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 Aulton, M. and Taylor, K. (2013). Aulton’s Pharmaceutics: The Design and Manufacture of
Medicines, (4th ed.). Edinburgh: Churchill Livingstone.

 Ghosh, T. and Jasti, B. (2005). Theory and Practice of Contemporary Pharmaceutics. USA: CRC
Press LLC.

 Liu, R. (2018). Water-Insoluble Drug Formulation (3rd ed.). New York: Taylor & Francis Group.

 Mahato, R. and Narang, A. (2018). Pharmaceutical Dosage Forms and Drug Delivery (3rd ed.).
New
 York: Taylor & Francis Group

 Mehta R.M. ‘Pharmaceutics’ 2nd edition Vallabh Prakashan, Page no:-246-252

 Lachman, L., Lieberman, H. A., and Kanig, J. L. (1986 ), The Theory and Practice of

 Industrial Pharmacy, 3rd ed. , Philadelphia: Lea & Febiger.

 Allen L. V and Ansel H. C. (2014). Ansel’s Pharmaceutical Dosage Forms and Drug Delivery

 Systems. Philadelphia: Lipincott Williams and Wilkins.

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