Industrial Training Report

A Industrial Training Report is Submitted

In partial fulfillment of the Requirements
For the degree of
BACHELOR OF PHARMACY
Session 2023-2024
By
Saurabh
(2109910500045)
Under the Supervision of
DR. KAMAL AHMAD
(PROFESSOR, DIRECTOR)
MAA SARASWATI PARAMEDICAL INSTITUTE

To the
FACULTY OF PHARMACY
DR. A.P.J. ABDUL KALAM TECHNICAL INSTITUTE,
LUCKNOW
(formerly Uttar Pradesh Technical INSTITUTE, Lucknow)

1
 DECLARATION
I Saurabh, hereby to declare that work presented in the industrial training report entitled in
Industrial Training performed at ATHENS LIFE SCIENCES, PLOT NO.837/258/197,
MAUZA RAMPUR JATTAN, KALA AMB, TEHSIL- NAHAN, DISTRICT- SIRMOUR,
HIMANCHAL PRADESH- 173030

It is an authentic record of work carried out by me during 12/02/2024 to 23/03/2024 at Athens

life sciences, under the Guidance of MAA SARASWATI PARAMEDICAL, INSTITUTE
MARDAH GHAZIPUR (U.P.) is being submitted for partial fulfilment of the requirement for
the award of Bachelor degree in Pharmacy, this is not been submitted anywhere else for
awarded of any other degree/diploma.

Date-

Place- Mehengava, Mardah, Ghazipur

Submitted By-Saurabh
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 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.

I am thankful to all my teachers of MAA SARASWATI PARAMEDICAL INSTITUTE,

GHAZIPUR. For their blessing and encouragement.

I would like to express my special thank and gratitude to ATHENS LIFE SCIENCES and Mr.
MOHIT [Q.A Manager] for providing all the essential facilities which were required for this
training.

Finally, I express my regards to my beloved parents who inspired me throughout my studies

and completion of this training.

I am especially thankful to DR.Bishwajit Biswal (Professor) who gave me permission and

accompanied to complete my work.

I take privilege to acknowledge to all those who have helpful us in completion of work. I
express my deep sence of gratitude indebtedness to my guide Dr. Bishwajit Biswal
(professor), for their kind recommendation to complete my Indusrtial Training- 1

I am greatful to Maa Saraswati Paramedical Institute, Ghazipur for providing

infrastructure, computer lab, library, and other facility.

I am also thankful to my parents and classmates for their kind cooperation and the other whose
book. I had consulted while making the report and to my teacher and my dear friends.

Thanking You.

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 CERTIFICATE

This is certified that Mr. Saurabh S\o Mr. Ashok Kumar Sharma submitted the report on
Industrial Training for partial fulfillment of degree of Bachelor of Pharmacy 6 th Semester
2023-24 . The content of the report do not form the basis for the award of any other degree to
the candidate or to anybody else from this or another university/institution.

Dr. Kamal Ahamad

(Director)

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5
 INDEX

SR NO. NAME OF CONTENT Page No.

1 Company profile 07

2 Overview 08

3 Detail of Industrial Visit 09

4 Objective 11

5 Vision, Mission & Values 12

6 Company Layout 13

7 Organization Structure 14

8 List of Products 15

9 Tablet, Tablet Manufacturing 17

10 Tablet Coating, Tablet Excipients 20

11 Oral Liquids 22

12 Evaluation Of Oral Liquids 23

13 SWOT Analysis 26

14 PESTEL Analysis 29

15 Porter’s Five Forces Model Analysis 30

16 Safety Aspects of production Unit, Production 31

Capacity

17 Quality Control 32

18 Conclusion 35

19 Reference 36

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 COMPANY PROFILE
 Location- Athens life sciences, plot no.837/258/197, Mauza Rampur Jattan, Kala-Amb,
Tehsil- Nahan, District- Sirmour, Himanchal pradesh- 173030.
 Year of Establishment- 2001
 Certification- An ISO& GMP Certified Company
 Annual turnover- 52cr.
 GST No. - 02AAOFV7387B1ZZ.
 Company Registration No.- 241/2017.
 Contact No.-8307241553,Email- [email protected]

About Company-

Athens life science (formerly known as Athens

labs ltd.) was established in 2001 with vision of
providing quality & most affordable medicine
across the country. It is Best Third Party
Manufacturing and PCD Pharma Company.
With 2 decades of medicinal service to the
society. Athens is today one of the
leading pharmaceuticals manufacturing &
marketing company in India.

Athens is highly diversified , catering to a

variety of dosage forms like tablets, capsule, dry syrup , syrup , ointment, soap , sachet ,
powder

Athens Life sciences (An ISO 9001:2008 Certified PCD Pharma Company) strongly takes
care that the product shall meet the relevant Internal & Pharmacopoeia Standards & Statutory
Requirements.

We take an opportunity to provide our monopoly product distribution rights to the Franchise
owner. We are looking for Franchise/Distributors and associates District wise and state wise.

Site Capabilities-

 Manufacturing facility- Vitamin & Minerals Premixes Processing, Primary Packing,

Secondary Packing, and Sachet filling machine.
 General Tablet Granulation Area, Three Compression cubicles and three packing lines
 State of art Quality laboratory.
 Qualified and competent staff.
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 OVERVIEW
Industrial training is a prerequisite for student in certain programs at all level of Higher
education at the institute of higher learning (IPT). To increase the level of the work of the
graduates, the program was introduced to empower industrial training competency required. LI
course provide students with learning opportunities in the workplace to receive practical
experience in order to improve.

This course provide exposure and experience to the students in terms of the technology
development, effective communication, teamwork practice, policies procedure and regulation,
professional perspective and reporting.

This course will build enthusiasm and proactive attitude among students and increase their
confidence to be an excellent coach.

In general, institute of higher learning will undergo industrial training at the fourth semester;
industry training is done for six month in a firm or organization that has been selected by the
student or his assigned. After six months of industrial training students must be returned to
collage to present all activities during industrial training.

Overall, industrial training provide many advantage and benefit to students.

During the training period, student are exposed to a variety of activities in the field of duties,
even though the job is not done entirely by students for the purpose of security or regular
students were briefed and clear guidance and useful enough as a general knowledge, as well as
exposed to the real working environment and can learn social skills such as communication
and social relationship.

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 PICTURE OF INDUSTRIAL VISIT

PHOTO 1:- Group Photo while leaving for Industry

PHOTO 2:- Group photo at entrance gate of Industry

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 PHOTO 3:- Inside the industry

Description of Visit-

 Name of company- Athens Life Sciences

 Location Of trip- Athens life sciences, plot no.837/258/197, Mauza Rampur Jattan, Kala-
Amb, Tehsil- Nahan, District- Sirmour, Himanchal Pradesh- 173030.
 Date & Time of Visit- 02 March 2024, 11: 35 AM
 Program coordinator- Mr. Shashank Gupta (Astt. Proffesor), Dr. Kalam Ahmad (Principal)
 Company Guide- Mr. Mohit [Q.A Manager]

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 OBJECTIVE
The goal of Industrial Training is to give students a chance to work in a real-world setting and
learn how to do things by watching and doing them. The students will also learn about work
ethics, communication, management, and other items from the industrial training. This
practical training program also allows students to connect their theoretical knowledge with
how it is used in the manufacturing industry. In industrial activity, the main goals are:

Before making long-term commitments, students have the chance to see if they like a specific
job.

The goal is to learn how to apply theory to real-world situations. To learn skills and techniques
they can use in their jobs. A student’s sense of responsibility and good work habits will
improve if they go on a work placement. The goal is for students to get real-world work
experience and learn how to write a report for technical work or projects. As a result of their
internships, students will do better in school. Internship programs will help students earn more
money when they graduate.

Students will able to:-

 To build strength, teamwork spirit, and confidence.

 Students will improve their creative skills and share their ideas more effectively.
 The goal is to build good communication skills with a group of workers and learn how to
behave professionally at work in the industrial field.
 The student will be able to learn good moral values like responsibility, commitment, and
trustworthiness while they are in school.

Being trained in the workplace.

Industrial training is an integral part of the curriculum because it is thought to be the first job
experience that makes people professional. This is why it is essential to have it in the class.
During an internship at the company, students learn a lot and get a chance to work in the field.

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 VISION, MISSION & VALUES

Vision-
Athens Life Sciences are the leading healthcare professionals with a top ranking position in
India.

Athens Life Sciences in the leading manufacturer in Vitamins & minerals premixes and the
leading exporter of the same in all over the India.

Mission-
Athens Life Sciences ensure the quality, reliability, and innovation thereby enhancing the
sustainability and values for the entire stakeholder.

Values-
 Knowledge- Expertise and Innovation.
 Action- Entrepreneurship and Integrity.
 Care- Trusteeship and Humanity.
 Impact- Performance and Resilience.

The values that guide our culture and embodied in our Purpose-

“Doing Well and Doing Good “

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COMPANY LAYOUT

13
ORGANIZATION STRUCTURE

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 LIST OF PRODUCTS

Tablets-

1. Pantawell-40 2. Athur-300

3. Willnide-P 4.Wellcoxib-TH4

5. Caz-FX 200 DT 6. L Vocin-M

Soft gels-

1. Ath-D3 60 K 2. Athglow

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3. Athcod 4.Moxwel-LB 500

5. Oxysoft 6. Rebwell-DSR

Capsules-
1. Athcal-CT 2. Moxwel-LB 250

3. Ath-PG 4. Athzol-DSR

Syrup-
1. Athpha Syrup 2. Vitax Syrup

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 TABLET
Tablets:- Tablets is a pharmaceutical dosage form. Tablets may be defined as the solid unit
dosage form of medicament with or without diluents and prepared by moulding or
compression. It comprises of active substances and excipients. Usually in prepared powder
form, pressed, or compacted from a powder into a solid state. The excipients can include
diluents, binders, granulating, lubricating to ensure the efficient tableting. Sweeteners to give
the flavour, disintegrants to promote the break of tablet in stomach, and so on. The polymer
coating is done to make the tablet swallow easily.

The compressed tablet is most popular dosage form used today. About two third of all
prescription are dispensed as solid dosage form, and half of these are compressed tablet. A
tablet can be formulated to deliver an accurate dosage to specific site. It is usually taken orally
but can be administered sublingually, buccally, rectally, or intravaginally.

ADVANTAGE OF TABLET:-

 Cost is lower of all oral solid dosage forms

 Lighter and compact.
 Easiest and cheapest to package and strip.
 Sustained released product is possible by enteric coating.
 They are unit dosage forms and offer the greatest dose precision and the least content
variability.

DISADVANTAGE OF TABLET:-

 Difficult to swallow in case of children and unconscious patients.

 Some drugs resist compression into dense compacts, owing to amorphous nature, low
density character.

Tablet manufacturing:-

Manufacturing of the tableting blend:

In the tablet pressing process, the main guideline is to ensure that the appropriate amount of the
active ingredient is in each tablet. Hence all the ingredient should be mix well, if the
sufficiently homogenous mixture of the components cannot be obtained with simple blending
processes, them ingredient must be granulated prior to compression to assure an even
distribution of the active compound in the final tablet. Two basic techniques are used to
granulate the powder for granulation into the tablet. Wet granulation and dry granulation.

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 1. Wet granulation

The most widely used process of agglomeration in a

pharmaceutical industry is wet granulation. Wet
granulation process simply involves the wet mass of the
powder blend with a granulating liquid. Wetting size and
drying are important steps in involved in the wet
granulation.

Process:

a) Mixing of the drugs and excipients.

b) Preparation of the binder solution
c) Mixing of the binder solution with powder solution to form wet mass
d) Drying of the moist granules
e) Mixing of the screened granules with disintegrant, lubricant and glidant.

2. Dry granulation

In the dry granulation process the powder mixture is

compressed without the use of the solvent and heat. It
is the least desirable of all method of granulation. The
two basic procedures are to form compact of material
by compression and then mill to the compact to obtain
granules. Two methods are used for dry granulation.
The most widely used method is slugging where the
powder is recompressed and the resulting tablet or
slugs are milled to yield the granules. The other method is to precompress the powder with the
powder with pressure rolls using a machine such as chilosonator.

3. Roller compaction

The roller compaction of powder by means of pressure roll can also be accompanied by
machine called chilosonator. Unlike tablet machine the
chilosonator turn out a compacted mass in a steady
continuous flow. The powder is fed down between the
powders into the compaction zone like slugs. The
aggregates are milled or screened out for the
production into granules.

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 Processing Steps:

 Selection of raw material

 Weighing
 Size reduction
 Mixing (Precompression or slugging)
 Screening
 Lubrication
 Compression
 This method has also some advantage and disadvantage too.

4. Direct compression

This method is used when a group of ingredients can

be blended and placed in a tablet press to make tablet
without any of the ingredients having to be changed.
This is not very common because many tablets have
active pharmaceutical ingredients which will not
allow for direct compression due to their
concentration or excipients used in formulation are
not conductive to direct compression. Granulation is
the process of collecting particles together by creating bond between them.

General Operation:-

First the powder is filled into the die from above. The mass of powder is determined by the
position of the lower punch in the die, the cross section area of the die, and the powder density.
At this stage adjustment to the tablet weigh are normally made by repositioning the lower
punch. After the die and the powder is uniaxially compressed to a porosity of between 5 and
20%. The compression can takes place in one or two stage and for commercial production
occurs very fast. Finally the upper punch is pulled up and out of the die and tablet is ejected
from the die by lifting the lower punch until its upper surface is flush with the top face of the
die. This process is repeated for each tablet.

Common problem encounter in during tablet manufacturing operation

include:

 Fluctuation in tablet weight, usually caused by uneven powder flow into the die due to poor
powder flow properties.
 Fluctuation is dosage of the active pharmaceutical ingredients, caused by uneven
distribution of the AIP in the tableting blend.
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 .TABLET COATING:-
An application of coating material to the exterior of tablet with the intension of conferring
benefit and properties to the dosage form over uncoated variety.

Objective:-
 To make color, odor and taste of drug.
 To provide physical and chemical protection to drug.
 To control release of drug from tablet.
 To provide physical elegance.

Type of the tablet coating:-

 Sugar coating
 Film coating
 Press coating

The materials used for coating may largely comprise sucrose, water soluble film coating
polymers or substance which are soluble in intestinal secretions but not in those of the
stomach. This types of coating can be applied by the pan or fluid bed process. The compression
coating technique is suitable for sugar and enteric coating but not for film. The tablet coating
contains use of polymer, coloring agent, etc.

Tablet Excipients:-
Excipients are crucial to within the body. Generally, an excipients has no medicinal
properties.Its standard purpose is to streamline the manufacture of the drug product and
ultimately facilitate physiological absorption of the drug. Excipients might aid in lubricity,
flowability, disintegration, taste and may confer some form of antimicrobial function. Selecting
the appropriate excipients to support the design of our pharmaceutical formulation is an
important step in the drug manufacturing process. Different types of excipients used are:-

 Diluent
 Binder & Adhesive
 Disintegrant
 Superdisintegrant
 Lubricant & Glidant
 Colouring Agent
 Flavouring Agent
 Sweetening Agent

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 Diluent:- Diluents are fillers used to make required bulk of the tablet when the drug
dosage itself is inadequate to produce the bulk. Secondary reason is to provide better tablet
properties such as improve cohesion, to permit use of direct compression manufacturing or
to promote flow. E.g. Mannitol, Sorbitol, Sucrose, Dextrose etc..
 Binder & Adhesives:- These materials are added either dry or in wet- form to
form granules or to form cohesive compacts for directly compressed tablet.
Example: Acacia Tragacanth- solution for 10-25% Conc., Cellulose Derivative- Methyl
Cellulose, HPMC, HPC, Gelatin etc..
 Disintegrant: - Disintegration are added to the tablet formulation to facilitate its breaking
or disintegration when it contact with water in the GIT.Example: Starch, Clay, Cellulose
derivative, etc..
 Superdisintegrant: - Superdisintegrant are pharmaceutical excipients that are used to
break down tablets and capsule into smaller particles that dissolve more quickly in GIT.
This increase the rate of absorption in body. Example: Starch glycolate, crospovidone,etc.
 Lubricant & Glidant:- Lubricants are intended to prevent adhesion of the tablet materials
to the surface of dies and punches, reduce inter particle friction and may improve the rate
of flow of the tablet granulation. Glidants are intended to promote flow of granules or
powder material by reducing the friction between the particles.

Example:- Lubricant: Stearic acid, Magnesium Stearate, etc.

Glidant: Corn Starch, Silica derivative, etc...

 Colouring Agent: - The use of colours and dyes in a tablet has three purposes:
(1) Masking of off colour drugs.
(2) Product Identification.
(3) Production of more elegant product.
All colouring agents must be approved and certified by FDA. Two forms of colours are
used in tablet preparation – FD &C and D & C dyes. These dyes are applied as solution in
the granulating agent or Lake Form of these dyes. Lakes are dyes absorbed on hydrous
oxide and employed as dry powder colouring.

Example: FD & C, D & C, etc.

 Flavouring Agent: - For chewable tablet- flavour oil are used.

 Sweetening Agent: - For Chewable tablets- Sugar, Mannitol, Saccharine are used.

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 ORALS LIQUIDS
Oral liquids are homogeneous liquid preparations, usually
consisting of a solution, an emulsion, or a suspension, of one
or more active ingredients in a suitable liquid base. They are
prepared for oral administration either as such or after
dilution.

Steps for manufacturing of oral liquids:

The below mentioned steps are usually involved in the manufacturing of the oral liquids
formulation in stepwise manner. Each step has its unique role in the process of manufacturing
of the pharmaceutical oral liquid dosage form.

1. Planning of materials Requirement

2. Liquid Preparation

3. Filling

4. Labeling

5. Packaging

6. Sales of Drugs Products

The most important step in the manufacturing is the planning of material requirement it usually
done by the quality peoples. By the proper planning one can set the benchmark for the
manufacturing. Liquid preparation is another step which is play important role. Here the 75%
of the work is done of the manufacturing of oral liquid. Then filling and labeling are also done
with the help of labor assign too the same purpose.

After labeling packing is done to ensure the products used for the mankind. Lastly the most
important phase of the oral liquid manufacturing is get performed called sales of the drug
products.

List of the equipment used in the manufacturing:

The given below are some equipment used in the formulation of oral liquid

1. Mixing and storage tank

2. Portable mixer
3. Colloid mill
4. Filter press
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 5. Semi automatic bottle filling machine
6. Water still
7. Labeling machine

1. Mixing and storage tank: Mixing tanks are used in chemical process
systems to mix multiple liquid components together to create new
compounds or products. These tanks typically feature separate
inputs for each component, as well as output piping to feed the
mixture into the next phase of the process system.
2. Portable mixer:- Mixing equipment for the pharmaceuticals
industry are designed to blend the powders gently without
generating excess heat. Besides blending, pharmaceutical mixers
perform a range of other processes including dissolving powders
and solids, combining raw materials, preparing fine
emulsions, particle-size reduction.
3. Colloidal mill:- A colloid mill is a machine that is used
to reduce the particle size of a solid in suspension in a
liquid, or to reduce the droplet size in emulsions. Colloid
mills work on the rotor-stator principle: a rotor turns at
high speeds (2000–18000 RPM).

4. Filter press:- Filter presses are used for liquid/solid

separation in an extensive range of industries and
applications including: Food and beverage processing,
Chemical manufacturing.

5. Semi Automatic Bottle Filling Machine:- The liquid

filling machine operates on the principle of liquid pressure
filling. When the pressure is high, the liquid flows into the
bottle using its own weight. This process occurs when the
pressure of the liquid reservoir matches the volume of air present in the
bottle.

6. Water Still:- Water stills, also called laboratory water distillers, heat
water to a volatile vapor phase thus separating it from nonvolatile
impurities. While the terms deionized and distilled water are often used
interchangeably, there are significant differences in the types of impurities that are removed
from each.

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7. Labeling Machine:- A labeling machine is a type of machine
used to apply labels to packaging or products. In addition to
applying labels, some labeling machines are capable of
producing them.

Formulation of oral liquids:

Drugs and range of excipients include…..

1. The vehicle: - purified water and oil

2. Co-solvent:- propylene glycol and glycerine
3. Surfactants: - to enhance the surface activity
4. Preservatives: - used against microbial contamination
5. Sweetening agents: - glucose, saccharin, aspartame
6. Buffering agents: - to regulate the pH of formation
7. Antioxidants: - BHA and BHT

Evaluation of oral liquids:-A solution is a liquid preparation that contains one or more
soluble chemical substances dissolved in a specified solvent. The given below are some step
of evaluation for oral syrup.

1. Determination of particle size and particle count.

2. Determination of phase separation.
3. Sterility test
4. Leaker test
5. Pyrogen test
6. Clarity test
7. Visual Inspection
8. pH Measurement

1. Determination Of Particle Size And Particle Count:- Determination of changes

in the average particle size or the size distribution of droplets is an important parameter
used for the evaluation of emulsions. It is performed by optical microscopy, sedimentation
by using Anderson apparatus and Coulter apparatus.
2. Determination Of Phase Separation:- This is another parameter used for assessing
the stability of the formulation. Phase separation may be observed visually or by measuring
the volume of the separated phases.
3. Sterility Test:- Sterility testing attempts to reveal the presence or absence of viable
microorganisms in a sample number of containers taken from a batch of products. Based on
results obtained from testing the sample a decision is made as to the sterility of the batch.

24
 The primary official test is performed using filtration but the direct transfer is used if
membrane filtration is unsuitable. These tests are further divided into two part….

(a) Membrane filtration Method.

(b) Direct inoculation Method.

4. Leaker Test: - Leakage occurs when a discontinuity exists in the wall of a package that
can allow the passage of gas under the action of pressure or concentration differential
existing across the wall.

 The presence of capillary pores or tiny cracks can cause microbes or other dangerous
contaminants to enter the ampoules or may lead to the leakage of contents to the outside.
This may lead to contamination of the sterile contents and also spoilage of the appearance
of the package.
 Changes in temperature during storage can cause expansion and contraction of the
ampoule and its contents, thereby accentuating interchange if an opening exists.
 Leaker test for ampoules is intended to detect incompletely sealed ampoules so that they
can be discarded to maintain the sterile conditions of the medicines.
 Tip seals are more likely to be incompletely closed than pull seals. Open capillaries or
cracks at the point of seal result in leakers.

5. Pyrogen Test: - Pyrogen as a class are fever-inducing substances that can be harmful or
even fatal if administered to humans above certain concentrations. Water can be a source of
pyrogens, so it may be important to routinely monitor water systems using the bacterial
endotoxins test.

LAL bacterial endotoxin test: The LAL (Limulus amebocyte lysate) assay is an in-vitro
assay used to detect the presence and concentration of bacterial endotoxins in drugs and
biological products. Endotoxins, which are a type of Pyrogen, are lipopolysaccharides
present in the cell walls of gram-negative bacteria.

6. Clarity test: - The clarity of the formulations before and after gelling is determined by
visual examination of the formulations under light alternatively against white and black
backgrounds.

7. Visual Inspection: - With a visual inspection, the ingredients and the final products are
carefully examined for purity and appearance. The physical appearance of products for
patient adherence and compliance is critical so it should be good like ,elegance in
appearance.
8. pH Measurement:- The measurement and maintenance of pH is also a very important
step in quality control testing. Generally, there are two different types of methods used in
the measurement of pH.

(a) pH paper .
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 SWOT Analysis
 SWOT Analysis is a strategic planning technique
that helps identify internal and external factors
that relate to business competition or project
planning. It can also be situational assessment or
situational analysis.
 The pharmaceutical industry spans a wide
spectrum ranging from Research & Development
to production to marketing. Companies with
limited resources in finance, manpower and other
facilities need to priorities and make decisions as to what can be done in-house against what
needs to be outsourced. The concept of which is little complex and ever-changing. As there
are many internal and external factors which can impact the success of a pharmaceutical
company.
 A SWOT analysis for pharmaceutical industry can be one of the valuable tools to assess
their strengths, weaknesses, opportunities, and threats. It is important for every pharma
company to develop strategies to capitalize on their strengths, address their weaknesses,
exploit opportunities, and mitigate their threats.
A SWOT analysis for pharmaceutical industry includes:
1. Strengths - The Pharma Company’s Roadmap to Innovation:- It include…

Research and Development: The pharmaceutical industry is known for its vigorous research
and development capabilities, leading to the discovery of new drugs and treatments.

Global Reach: Many pharmaceutical companies operate globally, allowing them to access
various markets and customer bases.

Diverse Product Portfolio: Pharmaceutical companies offer a wide range of products to treat a
variety of diseases and conditions. This allows them to meet the needs of a broad spectrum of
patients.

Strong Regulatory Barriers: Strict regulations and high entry barriers protect established
pharmaceutical companies from new competitors.

Brand Recognition: Established pharmaceutical companies often have strong brand

recognition and trust among healthcare professionals and patients.

2. Weaknesses - A Healthy dose of Reality - It includes….

High Development Costs: Developing a new drug is a lengthy and expensive process, and
there's no guarantee of success.

Regulatory Challenges: Strict regulatory requirements can slow down the approval process for
new drugs and increase compliance costs.

26
Litigation Risk: Pharmaceutical companies may face lawsuits related to product safety and
marketing practices.

Dependency on Key Products: The industry can be heavily dependent on a few blockbuster
drugs, making companies vulnerable if these drugs lose patent protection.

3. Opportunities – Navigating the Road Ahead for Pharma Companies –

Biotechnology Advancements: Advances in biotechnology, genomics, and precision medicine
offer opportunities for innovative drug development.

Tele-health Medications: The rise of telemedicine and digital health platforms opens new
channels for reaching patients and healthcare providers.

Aging Population: The aging global population creates a growing demand for healthcare
services and medications.

COVID-19 Pandemic Response: The pandemic has accelerated research in vaccines and
antiviral drugs, offering opportunities for the pharmaceutical industry.

4. Threats – The Pharma Company’s Vaccine for Threats – It includes…

Increased Generic Competition: Loss of patent protection exposes branded drugs to

competition from cheaper generic versions.

Regulatory Changes: Shifting regulations, especially related to drug pricing and approvals,
can impact the industry's profitability.

Drug Pricing Pressure: Government and high tax payer pressure to control drug prices can
affect profit margins.

Counterfeit Medications: The increase in counterfeit drugs poses risks to patient safety and the
industry's reputation.

Healthcare Access Challenges: Disparities in healthcare access and affordability can limit the
market for pharmaceuticals.

The pharmaceutical industry is a complex and challenging industry, but it also offers
significant opportunities for growth. Pharmaceutical companies that are able to capitalize on
these opportunities and mitigate the threats will be well-positioned for success in the years.

A SWOT analysis can be a valuable tool for pharmaceutical companies to assess their current
state and develop strategies for future growth and success

27
HOW TO DO SWOT ANALYSIS

28
 PESTEL ANALYSIS
The management of a company uses PESTEL analysis to weigh the factors that can hinder or
promote the industry's growth. From this PESTEL analysis of the pharmaceutical industry, it
can identify how political, economic, socio-cultural, technological, ecological, and legal issues
can impact the conditions of the pharmaceutical industry.

Pharmaceutical Industry PESTEL Analysis:-

The PESTEL analysis pharmaceutical industry can give companies an idea about the external
factors which can have a temporary or lasting impact on the pharmaceutical industry. The
given list shows the effect of the external factors:

Political Factor: For any business to flourish, it is essential to have a stable political condition.
Here are some political conditions which can impact the pharmaceutical industry:
 Most countries maintain frameworks that include guidelines about safety standards,
certifications, etc. They also mark the banned drugs, which may cause health hazards. If a
pharmaceutical company fails to follow those regulations, its business may suffer severely.
 Administrations of most countries try to gain control over the price of the drug to make it
affordable for people. It may toll on the growth of pharmaceutical companies.
 Governments of some countries subsidize the pharmaceutical companies to keep the
essential drugs within the commoners' reach. It helps the companies to survive in the
competitive market.

Economic Factors: The economy of any direct impacts the businesses. The pharmaceutical
industry is also affected when the economic conditions of a country get affected. The PESTEL
analysis pharmaceutical industry can identify the economic conditions which can affect the
pharmaceutical companies:
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 As the economic conditions of the countries are developing with time, the household
income of people is also increasing. It may allow them some essential drugs. They may
have the urge to buy costlier drugs, which were previously out of reach for many people.
 The researchers are constantly working on drug modification, resulting in more beneficial
and potential drug production. As people are buying those drugs, the pharmaceutical
industry is also flourishing.
 The average healthcare spending of the families is increasing. If there are aged people in a
family, there are more chances of high healthcare expenses. It also includes the cost of
medicines. It is also giving the pharmaceutical companies to earn better profit even after
following Government guidelines about pricing.

Social Factors: Socio-cultural factors of any country can impact the industries within the
periphery of the country. The pharmaceutical industry is not an exception, and the sociological
conditions dominate it gravely. Here are some sociological conditions which can impact the
growth of the pharmaceutical industry:

 The lifestyle of people has people incredibly fast yet stagnant. As a result, more people are
moving towards obesity. Thus, facing health conditions like diabetes, thyroid, hypertension.
The patients need continuous medication to deal with this. Hence the sales of the
pharmaceutical companies are also increasing.
 As the healthcare system has improved all over the country, the number of the aging
population is also growing. Hence, there is a need for more medicines for them than for the
younger ones. It creates a greater demand in pharmaceutical companies resulting in their
expansion.

Technological Factors: The pharmaceutical industry is greatly dependent on technological

innovations. The PESTEL analysis pharmaceutical industry can show how the technical
conditions can affect the business:

 The pharmaceutical industry is greatly dependent on technology. The research and

biotechnological innovations have resulted in the production of drugs that are good in
quality and have low production costs. It will allow more people to get access to medicines
that they previously could not afford.
 The drugs require proper storage conditions. Technology has made it easier to preserve
medicines and transport them without getting harmed due to unpleasant conditions.

Environmental Factors: Environment is a significant concern, and the impact of waste

materials on the environment has worried the environmentalists. Here are some ecological
issues which may affect the pharmaceutical industry:

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 As the production of drugs is related to a large carbon footprint, many countries are coming
up with regulations to decrease the effect on the environment. As abiding by these
regulations may be costly for the new companies, they may fail to establish their business.
 The production of drugs results in the creation of different biotechnological pollutants. They
may be hazardous for people's health. The company needs to take care of this waste to
maintain the safety of the people.

Legal Factors: A nation's legal conditions do not have much direct impact on the
pharmaceutical industry. However, there can be some indirect issues that may affect the growth
of the pharmaceutical business. The PESTEL analysis pharmaceutical industry can help to
point out the legal aspects which can work on the growth of the pharmaceutical industry:

 As pharmaceutical products are one of the essential ones, the government always uses laws
to control the fraud regarding the expiration dates and manufacturing of the batch of drugs.
If a company fails to adhere to the set guidelines, it may have to face legal proceedings.
 Pharmaceutical companies are mainly dependent on their database. If they get affected by
cyber threats, the customer may lose their confidence in them. It can affect their business as
well.
 Pharmaceutical companies should maintain strict legal guidelines while formulating the
framework for their business and researches. They ensure the safety of the products. It helps
them to avoid legal issues. Thus, allowing them to stay away from the high expenses of
proceedings.

SAFETY ASPECTS OF PRODUCTION UNIT

When working in any type of laboratory, following basic laboratory safety is a necessity. The
Occupational Safety and Health Administration (OSHA) provide detailed guidelines on
laboratory safety. For laboratory workers, these guidelines should be second nature. A few of
the guidelines include:

a. Quickly clean up all spills

b) Maintain a tidy work area
c) Frequently wash hands
d) Wear a laboratory coat
e) Never smoke inside the laboratory
f) Label containers correctly
g) Wear eye protection and other personal protective equipment (PPE)
h) Do not wear clothing that exposes the skin (e.g, shorts and T-shirts)
i) Do not eat in the laboratory
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j) Regularly check that glassware is not cracked and that all equipment is safe to use
k) Keep entryways clear

These safety standards apply to any laboratory and can be altered to adhere to pharmaceutical
work specifically. Follow these practices as well as basic manufacturing practices like
maintaining and using the proper equipment. Besides basic laboratory safety and
manufacturing safety measures, there are many more safety standards for pharmaceutical
manufacturing sites. Here are a few other suggested pharmaceutical manufacturing safety
considerations.

PRODUCTION CAPACITY
The firm is engaged in the manufacturing and selling of generic drug formulation at its
manufacturing facility in Kala-Amb, H.P. with total installed capacity of manufacturing 7,500
lakh tablets, 6,000 lakh capsules, 450 lakh bottle of syrups, 1,100 Lakh of ointments and 300
lakh sachets respectively per month.

QUALITY CONTROL SECTION

It is the essay method in substance such as drugs, packing, material, raw material, adjuvant,
containers are checked according to the monograph as per standards given to the
pharmacopoeia

Following are the equipments used in QC section:

1. Magnetic stirrer
2. Electronic and simple balance
3. Capsule disintegration tester
4. Dissolution test apparatus
5. pH meter
6. Autoclave
7. UV and visible spectrophotometer
8. Leaker test apparatus

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1. Autoclave: Autoclave is a device used to sterilize the
equipment and supply by subjecting them to high pressure
saturated at 121 degree Celsius for around 10-15 minute.

2. pH meter: A pH meter is an electronic device

used for the measuring the pH of liquid
formulation. A typical pH meter consist of a
special measuring probe connected to an electronic
meter that measure the display the pH reading.

3. Dissolution test apparatus: In this apparatus the dissolution study of tablet is carried
out. A single tablet is taken and placed in wire mesh basket connected to variable speed
motor by mean of a shaft this basket is immersed in the dissolution medium contain in
100ml; flask. The flask is maintained at 37+-0.5degree Celsius by mean of constant temp
bath. Motor is adjusted to specified speed and sample of fluids are withdrawn at regular
time interval to determine the amount of drug in the solution.

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4. UV-Visible spectrophotometer: UV Visible spectrophotometer is used in pharmaceutical
industry due to its various application. It is one useful in detection of impurities, food
industry, forensic science, qualitative and quantitative analysis are carried out with the help
of the same.
5. Leaker Test Apparatus: Leak Test Apparatus is a solid
state instrument designed for the leakage testing of food, drug
and other industrial chemical products. The instrument is used
to test the quality of packing processes in strips, blisters and
sachets containing tablets, granulates and liquids.

6. Magnetic Stirrer:- A magnetic stirrer is a device widely used in laboratories and

consists of a rotating magnet or a stationary electromagnet that creates a rotating magnetic
field. This device is used to make a stir bar, immerse in a liquid, quickly spin, or stirring or

mixing a solution.

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 CONCLUSION
In the end I am glad to tell you that training in ATHENS LIFE SCIENCES, PLOT
NO.837/258/197, MAUZA RAMPUR JATTAN, KALA AMB, TEHSIL- NAHAN,
DISTRICT- SIRMOUR, HIMANCHAL PRADESH- 173030 was an excellent and fabulous
experience. During the training I actually learned about the pharmaceutical company and above
its working the theoretical in the book. We can only imagine about the thing we read, but
practical life is always different and excellent one. During My training period, I had seen the
various instruments and apparatus in the industry. The highly sophisticated instrument that
works precisely must be operated with intense care for optimum use.

Similarly from 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 also understood the importance of maintaining of
quality of products at pharmaceutical company.

I was successfully able to complete my short venture of training. Lastly I hope that my training
report fulfill the intended requirement.

-Regard

Saurabh

3rd year [5th Sem] B.Pharma

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 REFERENCE
1. www.athenslifesciences.com
2. www.edrawmax.com
3. www.Solacebiotech.com/Blog
4. Thakur Publication’s Industrial Pharmacy -1
5. Fundamental of Industrial Pharmacy.

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