Professional Documents
Culture Documents
At
Sun Pharma, Mohali
Acknowledgement
The internship opportunity I had with Sun Pharma, Mohali was a great chance for learning and
professional development. Therefore, I consider myself as a very lucky individual as I was
provided with an opportunity to be a part of it. I am also grateful for having a chance to meet so
many wonderful people and professionals who led me though this internship period.
I am using this opportunity to express my deepest gratitude and special thanks to Miss Jyoti
Gupta and Mr. Manjit Singh , who in spite of being extraordinarily busy with their duties, took
time out to hear, guide and keep me on the correct path and allowing me to carry out my
internship at their esteemed organization .
It is my radiant sentiment to place on record my best regards, deepest sense of gratitude to Mr.
Atul Aggarwal, Mr. Munish Roy, Mr. Kailash Niranjan for their careful and precious guidance
which were extremely valuable for my study both theoretically and practically.
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I perceive this opportunity as a big milestone in my career development. I will strive to use
gained skills and knowledge in the best possible way, and I will continue to work on their
improvement, in order to attain desired career objectives. Hope to continue cooperation with all
of you in the future.
Sincerely,
Vasudha.
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Table of Contents
Introduction……………………………………………………………………………………………………………………….………4-6
Training Sessions……………………………………………………………………………………………………………………….…7
Good Manufacturing Practices………………………………………………………………………………………………….……7
Good Documentation Practices…………………………………………………………………………………………………..….8
Data Integrity………………………………………………………………………………………………………………………..…..…..8
Data Reliability…………………………………………………………………………………………………………………………..…..9
Gowning and De-gowning Procedure…………………………………………………………………………………………..….9
Commitment to Quality……………………………………………………………………………………………………………..…..10
Finding Meaning At Work By Discovering A Higher Purpose……………………………………………………..……11
POSH Act…………………………………………………………………………………………………………………………………..……11
Communication Skills……………………………………………………………………………………………………………….…....12
Professional Competence……………………………………………………………………………………………………………....12
EHS………………………………………………………………………………………………………………………………………..………..13
Admin Block…………………………………………………………………………………………………………………15
Visits…………………………………………………………………………………………………………………………..16
EHS Visit………………………………………………………………………………………………………………………………….….16
Quality Unit Visit…………………………………………………………………………………………………………………………17
Production Visit…………………………………………………………………………………………………………………………..17-18
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Introduction
Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic
pharmaceutical company in the world with global revenues of over US$ 5.1 billion. Supported
by more than 40 manufacturing facilities, providing high-quality, affordable medicines, trusted
by healthcare professionals and patients, to more than 100 countries across the globe.
Founded in the year 1983, Sun Pharma now generates global revenue of $5 Billion+ with the
help of 3800+ employees across the globe.
Sunology
Sunology, a combination of Sun and Ideology is the way of life at Sun
Pharma.
Under promise and over Do the right thing with Infuse energy in Strive to implement new
deliver. conviction and without everything that you do. ideas & technologies to
fear. meet unmet needs.
Let your work speak for Walk that extra mile
you. Practice honesty, Inspire others. Encourage others to
impartiality and fairness think out-of-the-box.
Always put ‘we’ before at all times. Do your best in every
‘me’. Situation. Do not limit yourself.
Adhere to strong ethical
Learn from mistakes. and moral standards.
Values
Sun Pharma’s values represent their promise to their stakeholders.
Quality
Get it right the first time
Reliability
Maintain efficiency & discipline in all processes & systems and fulfil the promises
made to stakeholders
Trust
Be transparent in dealings
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Products
Sun Pharma produces a comprehensive, diverse and highly complementary portfolio of generic
and specialty medicines targeting a wide spectrum of chronic and acute treatments; their product
portfolio includes generics, branded generics, specialty, difficult-to-make technology intensive
products, over-the-counter (OTC), anti-retrovirals (ARVs), Active Pharmaceutical Ingredients
(APIs) and intermediates.
Use Drug
Hyperlipidemia Atorvastatin, Fenofibrate
Over reactive bladder Solefenacin
Obesity Orlistat
Neuropathic Pain Pregablin
Generic Medicines-
A generic drug is a medication created to be the same as an already marketed brand-name drug
in dosage form, safety, strength, route of administration, quality, performance characteristics,
and intended use. These similarities help to demonstrate bioequivalence, which means that a
generic medicine works in the same way and provides the same clinical benefit as the brand-
name medicine.
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Ethical Medicines-
An ethical drug is one that is sold under a special brand name. The manufacturer of the drug has
the exclusive right to sell that drug. Ethical drugs are made according to strict standards to ensure
quality.You may need a prescription to get an ethical drug, or you may be able to buy it over the
counter.Businesses that deals with production and marketing of ethical medicines are ethical
pharma business.
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Training Sessions
The employees of pharma need to be trained in order to meet the challenges faced in the pharma
industry. Effective training programs always impart a sense of responsibility to all employees to
perform their tasks with utmost care and commitment.
The interns, apprentice trainees and housekeeping staff were major focus of the training
program. The training program provided insight into various sectors of pharmaceutical
industries, namely warehousing, production, packaging, quality control and quality assurance.
The training program also threw light on various disciplines such as GxP like Good
Manufacturing Practices, Good documentation Practices along with the importance of data
integrity and reliability and so forth.
Production System-
The personnel employed in all the areas, especially production must be educated,
qualified and clean. The parameters of quality, quantity, sampling, controls and labels
must be met to produce a quality product. Production process must be validated.
Material System-
All the material including the raw material, bulk, intermediates, finished products and
excepients must be tested. Principle of FEFO(First Expired First Out) must be followed at
all times. The material should be separated and stored carefully.
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2.Good Documentation Practices-
Proper documentation is the backbone of current Good Manufacturing Practices (cGMP) and in
the regulatory world, it is commonly held that “If it isn’t documented, it wasn’t done!” Documents
provide a means of identification.
3.Data Integrity -
Data integrity is the accuracy, completeness, and quality of data as it’s maintained over time and
across formats. Preserving the integrity of the company’s data is a constant process. Achieving
and maintaining data integrity can save the organization the time, effort, and money it would cost
to make a big decision based on incorrect or incomplete data.
The ALCOA principle states that data should have the following five qualities to maintain data
integrity:
Attributable
Legible
Contemporaneous
Original
Accurate
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4.Data Reliability-
Data reliability goes beyond assessing completeness and accuracy. Data reliability refers to how
consistent data can be across multiple records, programs, or platforms. It also refers to how
trustworthy a data source is.
Six elements critical for data reliability are-
Technology systems,
Process design,
Risk management,
Governance
Culture
Capability
This process is carried out to minimize the number of particles and viable microorganisms,
prevent contamination and to ensure the safety of the individuals working in manufacturing
areas.
Gowning Procedure-
Obtain a gowning package and inspect its integrity.
Place the contents of the package on bench. Avoid touching the coverall to the floor at
all times.
Inspect the boots for rips or tears, place on bench.
Unzip the coverall. Gather the arms and one leg of the coverall together.. Place leg in
coverall and pull up the coverall. Repeat the process with the other leg
Do not allow the coverall to touch the floor.
Pull the coverall up over the body and zip make sure base of hood is covered
Sit on bench and put on a single boot. Swing leg over bench to clean side of gowning
area. Apply other boot and stand on clean side of gowning area.
Put on sterile gloves. Sanitize gloves with sterile 70% (v/v) IPA
After gowning, employees may enter the manufacturing area.
Degowning Procedure-
Sit on the bench.
Remove goggles and boots, one at a time without letting anything touch the floor.
Continue to use the bench while removing the coverall. Grasp cuffs to waste and remove
coverall.
Place the garment in the appropriate receptacle for reprocessing or hang it if it has to be
re-donned.
Snap boots to the back of the coverall legs so that the boot tops do not come in contact
with the floor.
Remove the hood.
Hang the goggles.
Exit the change room and dispose of the hair cover, shoe covers appropriately.
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6.Commitement to Quality-
Sun Pharma’s commitement to Quality Policy ensures Customer Satisfaction,
Regulatory agency satisfaction, Permanent Employee and Stakeholder satisfaction.
All the products which are manufactured and distributed are specific, safe and
effective for patients.
Quality standards are met by following latest SOPs, effective training and its
sustainable execution.
Performance is reviewed on regular basis and all the inconsistencies are evaluated.
Sustainable quality culture is met by transparent communication, effective
management oversight, customer focus and continuous improvement.
The vision of Sun Pharma is “Reaching people and Touching Lives Globally as a
Leading Provider of Valued Medicine.”The center of working of Sun Pharma is its
patients.
Society
Individuals with no
health problems
Individuals with health
problems
From the above pie chart, it can be clearly seen that almost 95% of the population
suffers from some ailment or the other. Therefore, it is the utmost duty of all the
employees to serve their patients with commitment, passion, dedication and
responsibility.
Purpose is the desire to do things in service of something larger than ourselves. The
higher purpose is serving the society and ultimately serving the nation.
Purpose at work is understanding the fact that the role and work of each and every
employee matters equally and they responsible for the overall growth of the company.
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8. Sexual Harassment Of Women at Workplace (Prevention,
Prohibition, and Redressal) POSH Act
In the year 1992, Bhanwari Devi, employed with the rural development program of
The Government of Rajasthan was viciously gang raped because of her efforts to
stop the then prevailing practice of child marriage in support of the government’s
campaign against child marriage. However, due to the great political/social influence
of the family of the accused, the rape survivor did not get justice from the courts and
the rapists were allowed to go free. Supporting the cause of working women in India,
lawyers and women’s rights activists filed public interest litigation in the Supreme
Court under the banner of Vishaka. Vishaka Guidelines” were stipulated by the
Supreme Court of India, in Vishaka and others v State of Rajasthan case in 1997,
regarding sexual harassment at the workplace. After the Supreme Court judgment in
the case of Vishaka vs State of Rajasthan (1997), the Ministry of Women and Child
Development, after several years, passed the Sexual Harassment of Women at
Workplace (Prevention, Prohibition and Redressal) Act, 2013 (POSH Act).
Today, the POSH Act extends its guidelines to all the genders, without any biasness.
If any individual experiences gestures and behaviors of harassment at their
workplace, they must immediately report it to the higher authorities.
9.Communication Skills-
Communication is said to be the art of delivering the right message to the right
person. Communication must be clear, meaningful, understandable, interactive,
careful, assertive, tactful and interesting to send and receive ideas and feelings.
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Active listening plays a major role in successful communication. It involves-
Paying attention
Showing that you are listening
Feedback
Defer judgment
Respond appropriately
Good communication skills play a big role in the corporate world, it boosts
employee morale, engagement, productivity, and satisfaction. Communication is
also key for better team collaboration and cooperation. Ultimately, effective
workplace communication helps drive better results for individuals, teams, and
organizations .
10.Professional Competence-
Professional competencies are skills, knowledge and attributes that are
specifically valued by professional associations, organizations and bodies connected
to your future career.
One of the most important attributes necessary for selection in a company is an
individual’s resume. A resume must be simple, without any fancy colors or designs.
It should be well written and organized strategically; every detail of the resume
should be true and have practical significance.
Further, before appearing for an interview one must do a complete Google search for
the company they are willing to join, it is important to know the history, vision and
mission and other technical information related to the firm.
Furthermore, pay attention to even the minor details of your academics, even the
color of the textbook or the name of the author, the interviewer might ask a question
from any segment of your course.
Apart from this, it is equally necessary to find your purpose in life and fulfill it. It
helps you live your most conscious life and offers definite emotional and
psychological benefits!
11.EHS-
In India, 90% accidents occur due to unsafe acts, 7% due to certain conditions and
acts and the remaining 3% are natural disasters.
The EHS (environment, health and safety) department comes into play to avoid
accidents at workplace and also to maintain safe and sound working conditions by
identification of hazards, accidents and provides protection against them. The EHS
department works in harmony with the nature.Along with the safety of the
employees, this work team also ensures the well being of the environment.
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The two major goals of EHS are-
1. ISO implementation and documentation
2. Legal and statutory fulfillment ( paying various bills, obtaining different kinds of
licenses such as water consent, air consent etc.)
Permits are taken from EHS to carry out non-routine activities and such activities
are only carried out once the permit is granted.
EHS is also responsible for effective functioning of the OHC (Occupational
Health Centre). The OHC functions as a dispensary for the employees where a
pharmacist is appointed along with a patient bed to provide rest. Apart from this,
an ambulance is available 24/7 on the campus.
EHS also lays down an onsite emergency plan and provides first aid boxes and
numerous other anti-accident measures at every step.
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Organizing 2nd PACE
The 2nd PACE event was organized successfully at the Mohali campus. PACE was an inter
branch competition organized by Sun Pharma where employees from different departments came
together and formed a team. Each team addressed one primary problem faced by them and came
up with an apt solution for the same. The session was performed like a skit and each participant
exhibited great levels of energy and knowledge.
The interns were assigned various tasks such as jotting down the particulars of each team,
addressing certificates of participation to everyone and handing out gift vouchers. The team
members came up with unique names for their respective teams such as TEAM SAKSHAM,
TEAM FREE THINKERS, TEAM GOONJ, TEAM PARIVARTAN and TEAM YAEGER.
The above mentioned teams participated in the competition with great vim and zest. It was a
highly knowledgeable experience as we got to learn about the day to day problems faced in the
industry, be it high fuel expenditure or the struggles of carrying out HPLC. The session also gave
us an insight on the fact that no matter how big or complicated the problem is, with proper
support, guidance, knowledge and skill, one can always overcome it.
Quality review
All the interns were assigned different departments (such as MSTG, packaging, quality review)
under various department heads.
The quality review office comprised of various diligent professionals working in their cubicles,
reviewing the data obtained after carrying out specified tests on raw material, intermediates,
finished product and packaging material by the Quality Control department. I was given the
responsibility of making labels for each file and entering data on EDMS, a document
management system.
Label making- All the important information of each drug (such as atrovastatin) was compiled
and arranged in different files. The paperwork presented all the tests carried out on the drug, the
limits specified for each test and whether the drug passed or failed the respective tests. Each
batch was assigned a unique number and all these sheets were arranged systematically in files.
To avoid the unnecessary time consumption of having to sort between thousands of files during
the time of need, a printed label was attached on each file, indicating the unique code of each
drug’s data present inside.
Making these labels not only enhanced my MS Word skills but also made me familiar with the
procedure required to approve an API, excepients, raw material, packaging material and so on.
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EDMS- Apart from label making, I also uploaded data on the online document management
portal. Here, the manufacturing date, expiry date, batch number, retest period and the country to
which the drug is being exported to are entered. These entries have to be made carefully as any
discrepancy may affect the safety and effectiveness of the drug or the excepient.
Admin block
Coming back to the admin block, I was assigned different work each day, such as-
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VISIT
EHS VISIT-
The Environment, Health and Safety department extends its administration all over the 85 acre
campus of Sun Pharma, Mohali. Coming across this department made the interns familiar with
the following controls and sub parts of the unit-
Quality Unit-
The quality unit consists of various stations. It is necessary for all the individuals entering inside
the quality unit to wear aprons. The various sections are namely-
Storage – consists of glassware and chemicals arranged alphabetically, used to carry out
tests.
Testing lab- all the raw material, finished products and packaging material is tested in
these labs and upon their approval, the respective material is sent to the production,
warehousing department.
Instrument lab- comprises of various analytical devices used to check the purity, potency
and determine the impurities found in samples. Major instruments used are- Dissolution
Appratus, HPLC, IR, NMR.
X Ray crystallographer is installed in a different room which helps to determine the
hygroscopicity/ crystallinity of any compound.
A quarantine area where all the samples are stored and arranged in order of their
approval or rejection.
A particle size determining chamber.
A packaging material testing room enclosing various devices such as Pin Hole Tester,
Cap Sealer, Scruff tester.
A separate room for cleaning and drying of glassware used in testing.
A muffle furnace to determine elemental impurities and an Oven to calculate LOD (Loss
On Drying).
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All the data obtained from all these departments if finally sent to the quality review office
where it is reviewed and the necessary changes are made.
Production Area-
The Production area is the main area of the pharmaceutical facility which is responsible for
manufacturing of the pharmaceutical products. The production equipments were-
Fluidized Bed Dryer- commonly used in the pharmaceutical industry to reduce the
moisture content of pharmaceutical granules. It is the best technique used by the
manufacturer to produce a good quality product.
Capsule Filling Machine-These are primarily automatic filler machines that fill a set
amount of medication or pharmaceutical ingredients into the capsule.
Blister Packing Machine- This is an electromechanical machine that has both moving and
stationary parts that aid in packaging and sealing products in pre-formed cavities. This
machine is a unit-dose packaging for tablets, capsules, etc.
Dispensing and Finished Goods Section- Dispensing the right materials to the right
batches prior to the manufacturing process is a key activity. The process is critical when
working with potent active pharmaceutical ingredients (APIs) in drug manufacturing.
Decimal errors in API calculation can be life threatening.
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Finished goods are The goods are ready to be consumed or distributed. There is no processing
required in term of the goods after this stage by the seller.
Best Regards,
Vasudha
Summer Internship (Jul-Aug 2023)
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