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Dear Sir/Madam,
I am, A. Sreesivasakthi, a Final year student pursuing a Bachelor of
Pharmacy (B.Pharm) degree, would like to express my sincere gratitude to
Tablets [India] Limited and our esteemed Principal and Dean Dr. R.
Srinivasan sir, Faculty of Pharmacy, Bharath Institute of Higher Education
and Research.
I am profoundly thankful to Tablets [India] Limited for providing me with
the opportunity to engage in an enriching industrial training program. The
experience gained during my internship at their esteemed organization
has been invaluable in broadening my understanding of the
pharmaceutical industry. The exposure to their company's operations,
commitment to quality, and dedication to innovation have significantly
contributed to my professional growth and knowledge in the field of
pharmacy.
I would also like to extend my heartfelt gratitude to Dr. R. Srinivasan sir,
our Principal, and all my Faculty staff for their unwavering support and
guidance throughout my academic journey. Their mentorship and
encouragement have been instrumental in shaping my academic and
professional aspirations.
I consider myself fortunate to have had the privilege of learning from
Tablets [India] Limited, I am committed to applying the knowledge and
skills I have acquired to make a positive impact in the pharmaceutical
field.
Once again, thank you for the invaluable opportunities and support
provided to me during my academic and professional development.
Sincerely,
A.SREESIVASAKTHI.
ABSTRACT
This internship report provides a comprehensive overview of my
experiential learning journey at Tablets [India] Limited, a prominent
pharmaceutical company. The report delves into the pharmaceutical
industry's intricate dynamics and explores the specific functions and
operations of the company. It also highlights the roles and responsibilities I
undertook during my internship as a Final year B.Pharm student, shedding
light on the practical applications of pharmaceutical knowledge.
The report begins with an introduction to Tablets [India] Limited, detailing
its history, mission, and core values. It then proceeds to offer insights into
the pharmaceutical industry, discussing the critical role it plays in
healthcare and the global economy. The pharmaceutical industry's
regulatory framework and quality control standards are elucidated to
underscore the significance of compliance and safety.
The main body of the report provides an in-depth analysis of Tablets
[India] Limited's organizational structure, departments, and key functions.
Specific focus is given to the production, quality control, and research and
development departments, showcasing the company's commitment to
innovation and product excellence. Furthermore, the report presents a
detailed account of my internship experience, illustrating the tasks I
performed, challenges encountered, and lessons learned during my
tenure.
A critical aspect of the report is the exploration of Tablets [India] Limited's
dedication to pharmaceutical research and development. This section
highlights the company's contribution to the development of novel drug
formulations, its investment in cutting-edge technology, and its
commitment to improving patient healthcare outcomes.
Throughout the report, emphasis is placed on the pharmaceutical
industry's role in addressing global health challenges, and Tablets [India]
Limited's efforts to align with sustainable and ethical business practices.
This internship report serves as a comprehensive document that not only
outlines my practical exposure to the pharmaceutical industry but also
provides a broader understanding of Tablets [India] Limited's commitment
to quality, innovation, and patient welfare. It is a testament to the valuable
experiences gained during my internship, underscoring the importance of
bridging academic knowledge with real-world applications in the
pharmaceutical sector.
INTERNSHIP OBJECTIVES
Learning objectives for an internship at Tablets [India] Limited in the
pharmaceutical industry:
1.Understanding Pharmaceutical Operations: Gain a comprehensive
understanding of Tablets [India] Limited's pharmaceutical
operations, including drug manufacturing, quality control, research
and development, and distribution.
2.Compliance and Regulatory Knowledge: Learn about the regulatory
requirements and compliance standards governing the
pharmaceutical industry, including Good Manufacturing Practices
(GMP), FDA guidelines (or equivalent in your region), and other
relevant regulations.
3.Quality Control and Assurance: Develop skills in quality control and
assurance by participating in laboratory testing, quality checks, and
quality documentation processes to ensure the production of safe
and effective pharmaceutical products.
4.Pharmaceutical Research and Development: Gain exposure to
pharmaceutical research and development activities, including the
development of new drug
formulations, clinical trials, and the drug development life cycle.
5.Clinical Trial Management: Understand the processes involved in clinical
trials, including patient recruitment, data collection, trial
documentation, and the ethical considerations in human research.
6.Product Formulation: Learn about pharmaceutical formulation
techniques, including the development of solid dosage forms, liquid
formulations, and other drug delivery systems.
7.Documentation and Regulatory Affairs: Gain proficiency in maintaining
accurate and compliant documentation for pharmaceutical products,
including batch records and regulatory submissions.
8.Supply Chain Management: Learn about pharmaceutical supply chain
processes, including procurement, inventory management, and
distribution, to understand the flow of pharmaceutical products.
9.Laboratory Techniques: Develop laboratory skills, such as analytical
chemistry, microbiology, or molecular biology, depending on your
role and department.
10.Data Analysis: Gain proficiency in data analysis tools and techniques
for interpreting pharmaceutical research and clinical trial data.
11.Ethical and Regulatory Awareness: Understand and adhere to ethical
standards in pharmaceutical research and ensure compliance with
industry regulations and guidelines.
12.Problem-Solving and Critical Thinking: Enhance problem-solving and
critical-thinking skills by addressing real-world challenges in drug
development and manufacturing.
13.Professional Communication: Improve written and oral communication
skills through interactions with colleagues, superiors, and clients within
the pharmaceutical industry.
14.Team Collaboration: Collaborate effectively with cross-functional
teams, including
research scientists, pharmacists, regulatory experts, and quality
assurance professionals.
15.Professional Networking: Build a professional network within the
pharmaceutical industry by connecting with colleagues, mentors,
and industry professionals.
16.Continuous Learning: Embrace a culture of continuous learning by
attending relevant training sessions, workshops, and seminars offered
by the company.
17.Adaptation to Technology: Stay updated with emerging technologies
and trends in the pharmaceutical industry, especially in areas like
biotechnology and digital health.
18.Contributing to Innovation: Participate in brainstorming sessions and
contribute
innovative ideas or solutions that could benefit Tablets [India]
Limited and the pharmaceutical industry as a whole.
TABLETS[INDIA] LIMTED
Tablets India Ltd, the flagship company of the closely held JHAVER GROUP
is one of the leading companies in the Indian Pharmaceutical industry.
They are recognized as the Pioneers in revolutionizing Probiotics, Amino
Acids, and GI Lavage therapy in India and currently are ranked among the
leaders in India and Nepal in these segments.
Tablets (India) Limited was one of the early pharma ventures in India and
was founded in 1938 by Mr. Sri Krishna Jhaver.
Tablets India Ltd is one of the leading companies in India and operates via
9 divisions across the human health & and animal health business with a
combined field force strength of 2000 dedicated and loyal employees
positioned across India.
With an objective of increasing its presence in the global market, Tablets
India Ltd has established geography-specific partnerships with leading
export houses and has established focused JVs under the names of Tablets
MedoPharm Pvt Limited and Tablets Global Care Pvt Limited
nts
The departments visited during our internship program were listed below:
Quality control unit
Small Volume Parenterals
[SVP]
Large Volume Parenteral
[LVP]
Liquid orals productions
Tablets production unit
Fig 1: ph probe
Observation: A heavy metal limit test was observed, Chemists were
adjusting the pH of Ferrous Glycine Sulphate.
PARTICLE COUNTER:
A particle counter is used for monitoring and diagnosing particle
contamination within specific clean media, including air, water, and
chemicals. Particle counters are used in a variety of applications in support
of clean manufacturing practices, Industries include electronic components
and assemblies, pharmaceutical drug products and medical devices, and
industrial technologies such as oil and gas.
Fig 2: Particle counter
Observations: I was able to go through the liquid particle counter of both SVP
and LVP
SVP LVP
2ml – 10ml products 100 ml – 500ml products
10 microns – 6000 microns 10 particles – 25 particles
PROCEDURE:
Before injecting the sample, the instrument is set to run in water for the
cleaning process
Sample is injected
The process is repeated three consecutive times to obtain the mean value
DISSOLUTION APPARATUS:
Dissolution, in the context of pharmaceuticals, refers to the process by
which a solid dosage form, such as a tablet or capsule, disintegrates and
disperses into solution when exposed to a specific solvent under controlled
conditions. This dissolution process is a key determinant of how a drug is
absorbed by the body and ultimately exerts its therapeutic effect.
GAS CHROMATOGRAPHY:
Gas chromatography is the process of separating compounds in a mixture
by injecting a gaseous or liquid sample into a mobile phase, typically
called the carrier gas, and passing the gas through a stationary phase. The
mobile phase is usually an inert gas or an unreactive gas such as helium,
argon, nitrogen, or hydrogen. The stationary phase can be solid or liquid,
although most GC systems today use a polymeric liquid stationary phase.
The stationary phase is contained inside of a separation column.
.
FIG 5: STABILITY CHAMBER
OSMOMETER:
An osmometer is a laboratory instrument used to measure the osmotic
concentration of a solution, reflecting the number of solute particles
dissolved in it. It is particularly valuable in the pharmaceutical and clinical
settings for assessing the osmolality of biological fluids and
pharmaceutical formulations. By determining osmolality, which is the
measure of the solution's osmotic potential, osmometers contribute to
quality control in drug manufacturing and aid in diagnosing conditions
related to abnormal fluid balance or renal function in clinical settings. This
information is crucial for ensuring the safety and efficacy of
pharmaceutical products and assessing patient health.
FLAME PHOTOMETER:
A flame photometer is a scientific instrument used for the qualitative and
quantitative analysis of metal ions based on their characteristic emission
spectra when introduced into a flame. It is commonly employed in
analytical chemistry, particularly for measuring the concentration of alkali
and alkaline earth metal ions in a sample. The instrument works by
aspirating a sample into a flame, where the metal ions are vaporized and
then emit light at specific wavelengths. By measuring the intensity of the
emitted light, the concentration of specific metal ions can be determined.
Flame photometry finds applications in various fields, including
environmental analysis, clinical chemistry, and research laboratories.
INSTRUMENTATION ROOM 3:
DISINTEGRATION APPARATUS:
A disintegration apparatus is a pharmaceutical testing instrument used to
evaluate the disintegration time of oral solid dosage forms, such as tablets
and capsules. The disintegration process assesses how quickly a dosage
form breaks down into smaller particles when exposed to a specified fluid
environment, typically water.
FIG 6: DISINTEGRATION APPARATUS
This test helps ensure that the pharmaceutical product will disintegrate
appropriately in the gastrointestinal tract, allowing for optimal drug
absorption.
MELTING POINT APPARATUS:A melting point apparatus is a laboratory
instrument used to determine the temperature at which a substance
transitions from a solid to a liquid state.
INSTRUMENTATION ROOM 4:
WEIGHING MACHINE:
A weighing machine, also commonly referred to as a scale, is a device
used to measure the mass or weight of an object. It typically consists of a
platform or pan where the object is placed and a system of levers, springs,
or electronic components that respond to the force exerted by the mass.
Weighing machines come in various types, including mechanical (analog)
scales and electronic (digital) scales. Digital scales are more prevalent
today, providing accurate and easy-to-read measurements.
TAP DENSITY TESTER:
A tap density tester is a laboratory instrument used to measure the tapped
density of a powder or granular material. The tapped density is a key
parameter in pharmaceutical, food, and powder metallurgy industries,
providing information about the packing characteristics of a powder under
defined conditions. The instrument operates by repeatedly tapping a
container filled with the powder, compacting it over time
.
FIG 11: TAP DENSITY TESTER
WET AREAS:
In a Quality Control (QC) laboratory, a wet area refers to a designated
space equipped and designed for performing analytical procedures that
involve liquid reagents, solutions, or other wet chemicals. This area is
specifically set up to handle sample preparation, wet chemistry
techniques, and other processes that involve the use of liquids.
We are allowed to visualize the Moffler, hot air oven, water bath, water
supply equipment.
Three stone benches were allocated for the titrations and QC analyst
demonstrated the titrations and thoroughly explained the QC process of :
FEVASTIN IP [Paracetamol
injection]
ASTYFER XT TABLET
ASTYFER Z SYRUP
PEGLAC – G.I LAVAGE
PEGLAC PLUS
MULTI VITAMIN INFUSION
The above titrations were completely performed by the staff members
following the SOP designed be the company.
MICROBIOLOGY AREA:
The microbiology area within a pharmaceutical or biotechnology facility is
a specialized zone dedicated to ensuring the sterility and quality of
products. Maintained under controlled conditions, this environment
employs cleanrooms, laminar flow hoods, and rigorous protocols to
prevent contamination
.
FIG 12: MICROBIOLOGY AREA
Microbiologists conduct a range of tests, including microbial identification,
environmental monitoring, bioburden and endotoxin testing, and sterility
testing. Culturing and incubation processes help quantify and identify
microorganisms, while method validation ensures testing accuracy. Strict
training and gowning procedures, coupled with comprehensive
documentation, contribute to compliance with regulatory standards such
as Good Manufacturing Practices (GMP). The microbiology area plays a
pivotal role in upholding the safety and efficacy of pharmaceutical and
biotechnological products through meticulous microbial analysis.
QC FOR PACKAGING
Quality Control (QC) for packaging in various industries involves rigorous
processes to ensure
that packaging materials and methods meet specified standards and
requirements. Here are
some key aspects of QC for packaging:
1.Material Inspection: QC starts with the inspection of packaging
materials. This
includes checking the quality and specifications of materials such as
paper, cardboard, plastic, glass, or metal used for packaging.
2.Print Quality: If the packaging involves printing, QC assesses the print
quality, accuracy, and legibility of labels, instructions, and other
printed information.
3.Dimensional Checks: Ensuring that the packaging dimensions meet the
specifications to accommodate the product properly.
4.Seal Integrity: Verifying the integrity of seals, closures, and joints to
prevent leakage or contamination during transportation and
storage.
5.Barcoding and Labeling: Checking the accuracy and readability of
barcodes and labels for traceability and regulatory compliance.
6.Physical Durability: Assessing the physical durability of the packaging to
withstand handling, transportation, and environmental conditions.
7.Regulatory Compliance: Ensuring that the packaging meets relevant
regulatory
requirements and standards, including those related to safety,
environmental impact, and product information.
8.Compatibility: Verifying that the packaging is compatible with the
product, preventing any interactions that might affect product quality.
9.Batch Consistency: Maintaining consistency in packaging across different
batches or production runs.
10.Functionality Checks: Verifying features such as child-resistant
closures, tamper- evident seals, and other functionalities, especially
in industries like pharmaceuticals.
11.Environmental Impact: Considering sustainability factors, such as
recyclability and eco-friendly materials, in accordance with industry
and regulatory trends.
I am able to witness every QC procedure for packaging material done by
the staff members.
Through this, I’m able to understand the quality of medicine plays a vital
role in every aspect of providing safety to the patient
SMALL VOLUME PARENTERAL UNIT
A Small Volume Parenterals (SVP) unit in the pharmaceutical industry is a
specialized manufacturing facility that focuses on the production of sterile
injectable drug products in small volumes. SVP typically refers to injectable
drug formulations with volumes less than or equal to 100 milliliters. These
products are administered through various routes, including intravenous
(IV), intramuscular (IM), and subcutaneous (SC).
Recycling
Sterilization
6 Stokes 4 Stokes
8 Stokes
Sealing
In the SVP unit, we are able to visualise every process via the allocated
see-through transparent window as every process took place under sterile
conditions, and every staff member was strictly following their respective
guidelines. The air supply from the Laminar air flow chamber is 98.3%
fresh air which has no contamination and filling of SVP [1,2,3,4] is done by
grading system [A, B, C, D] of 100ml, 1000ml, 10000ml, 100000ml.
Filling 1: This process is ON-LIVE, ie. One day process of washing,
sterilizing, and filling
Filling 2, 3, 4: This process is OFF-HAND, ie.[two days process] The
process of washing and sterilizing is done on day 1 and filling is done on
day 2. Vial filling follows this type.
After the filling process, the ampoules or vials are sent to the Labelling
section which is labeled with the respective details with mfg date, batch
no, and exp date.
After labeling the ampoules or vials are sent to Visual checking, This visual
checking is done twice by machine as well as manual checking, if found
any fiber particles or any impurities the product is immediately rejected
and discarded. Accepted products are packed accordingly and dispatched.
The SVP products manufactured byTablets India are :