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INDUSTRIAL TRAINING REPORT

BY
RAJEEV KUMAR

CONTENT
CERTIFICATE OF STUDENT
CERTIFICATE OF INSTITUTE
CERTIFICATE
ABOUT THE COMPANY OR INDUSTRY
INTRODUCTION OF REPORT
CONCULSION

LLOYD INSTITUTE OF MANAGEMENT & TECHNOLOGY (PHARM.)


Plot No.11, Knowledge Park-2, Greater Noida, Uttar Pradesh 201306

Certificate from Student


Name: Rajeev Kumar
Roll No: 1901720500070
Subject: Industrial training

This is certified that this report represents bona-fide training of mine in the
Pharmaceutical Industry during the academic session2021-2022
Industrial training done from 01 February 22 to 02 March 22.The report is
complete in all respect.
Signature with Name
         (Student)

Date: ………………….

LLOYD INSTITUTE OF MANAGEMENT & TECHNOLOGY (PHARM.)


Plot No.11, Knowledge Park-2, Greater Noida, Uttar Pradesh 201306

Certificate from Institute


Name: RAJEEV KUMAR
RollNo:1901720500070
Subject: INDUSTRIAL TRAINING

This is certified that this report represents bona-fide training of the student in the
Pharmaceutical Industry during the academic session2021-2022.
Industrial training done from …01 FEBURARY 2022….to …02 MARCH 2022… The
report is complete in all respect.

………………………….. Date: …………………..


Signature with Name Institutional Seal
(Course Coordinator)
CERTIFICATE

ABOUT THE INDUSTRY


Curadev Pharma Pvt. Ltd.

We are a small molecule drug discovery biotech with an exciting portfolio of


research programs that have yielded patent protected drug candidates.
Founded in 2010, Curadev has created a premier translational research
organization known for prescient target selection and high quality, data-driven
program execution. Our programs seek to ameliorate disease by translating
cutting edge discoveries into new medicines. We have swiftly established our
credentials by successfully creating and out-licensing our small molecule
patents to major pharmaceutical companies.

IMMUNE
ONCOLOGY
We are fascinated by the ability of tumors to evade immune elimination. Many
of our current programs focus on restoring the power of the immune system to
achieve clean tumor kills.

Tumors subvert immunity in a variety of ways. They can hide their very
existence from innate cellular alarm systems and circulating surveillance
immune cells, frustrate the buildup and amplification of immune responses
and subvert established inflammatory responses by evoking potent
immunosuppressive factors.

The recent approvals of inhibitors targeting checkpoint blockade are the first
steps in the establishment of host directed immune therapies as durable
methods for the treatment of a number of cancers. The coming decade will
see the emergence of new generations of immune system targeted oncology
drugs which can be used as monotherapy or in combination with other IO
agents or existing anti-cancer drugs.

RUNAWAY
IMMUNE RESPONSE
Chronically inflamed tissue is a consequence of a runaway immune response
that is characterized by the deposition of connective tissue enriched with
collagen and fibronectin.This is fibrosis, a phenomenon that inexorably leads
to permanent scarring of the tissue, organ malfunction and ultimately death
due to organ failure. Fibrosis is also a major pathological feature of many
chronic autoimmune diseases, including rheumatoid arthritis, ulcerative colitis
and lupus. 
 
Though it affects nearly every tissue in the body, the exact nature and
sequence of events that lead to fibrosis is unknown though the infiltration of
mononuclear immune cells is a common feature.  This infiltration is the basis
for the essential process of wound-healing that is triggered in damaged
tissues, but dysregulation of the healing process leads to excessive deposits
of connective tissue. 
 
The continuous debris from damaged cells leads to the  chronic activation of
STING (Stimulator of Interferon Genes) an important transducer of innate
immune signaling.    The pathology associated with constitutively activated
STING is most evident in the spectrum of human autoimmune disorders
termed SAVI (STING-associated vasculopathy with onset in infancy) that can
be a terminal disease striking young children.

ACETATE
METABOLISM
Cells under stressed conditions of hypoxia and glucose depletion turn to other
biomolecules to fulfill their energy needs.  One such biomolecule is acetate
which can be sourced directly from the circulation or freed up within cells by
the action of stress activated enzymes.  Acetate is readily converted to acetyl
CoA that enables numerous cellular functions.  
 
Survival requires dynamic reprogramming and rebuilding of cellular machinery
to deal with the challenges of the new environment.  This is achieved by
epigenetic gene expression programs that are activated by acetylating master
genes in the nucleus that redirect cellular priorities to overcome the
environmental stress. 

Studies demonstrating that tumor cells take up significant amounts of acetate


often in preference to glucose has led to the investigation of acetate
metabolism in cancer and stress.   The inner tumor mass is a poorly
vascularized nutritionally barren region in which cells survive by rewiring their
metabolism.  The propensity of certain tumors to take up acetate has been
exploited by using 11C-acetate guided positron emission tomography (PET)
imaging for the detection of primary tumors and distant metastases.  In fact,
11C-acetate guided PET has been reported to be more efficient than labeled
18Fluoro-Deoxy Glucose (18FDG) in detecting or grading gliomas,
hepatocellular carcinomas, non-small cell lung cancer and metastases in
prostate cancer patients.
NEUROSCIENCE
The central nervous system is an immune-privileged site because of its limited
powers of regeneration. However, in situations of either systemic or local
immune stimulation the CNS can induce inflammatory reactions.
 
Microglia and perivascular macrophages are the only permanently resident
immune cells in the brain of which the microglia constitute the largest
population constituting 20% of the non-neuronal population and derive from a
distinct population of CD45+ monocytic cells that migrate into the brain during
early embryogenesis. With their 3-D structure of their long fine motile
processes, they are responsible for immune surveillance. However, they also
play an important role in developmental processes such as neuronal
differentiation and synaptic pruning. Prolonged pro-inflammatory activation
state of microglia is linked to neurodevelopmental disorders and
neurodegeneration. Thus, the challenge is to return pro-inflammatory
microglia to a resting state without inducing acquired deactivation preventing
normal activation.

.
INTRODUCTION

MANUFACTURING FACILITY

OUR MISSION

To focus on creating business avenues through manufacturing and making available quality
products to our customers.
To be at the forefront of cutting edge technology and provide ongoing solutions.
To stand committed to delivering quality products by adhering to current GMP standards.
To strive to be the best-in-class manufacturing facility by constantly updating our domain
knowledge and personnel skills.

DEPARTMENTS AND THEIR FUNCTIONS

There department and their functions are briefly outlined below.


Quality Control Department
This department is otherwise known as the heart of the industry because it ensures
the quality of materials used and the finished product sold out to consumers
for their consumption they are mostly concerned with sample analysis,
specifications, organization, and documentation to ensure that the finished product
and raw materials are of standard. The quality control has the power and
jurisdiction to approve or reject any component, after adequate laboratory
procedures.

The quality control department is divided into three Units, they are;

a. Chemistry laboratory Unit.


b. Microbiology laboratory Unit
c. Quality assurance unit.

a. Chemistry Laboratory:
This section/unit caries out series of test on different products, they test for raw materials,
finished drugs, running of assay of different drugs samples, dissolution test etc. They also carry
out the in-process controls such as loss on Dryness test of granules, friability test, Disintegration
test, Weight Variation, leak test on blistered drugs etc. This role is very vital for the effective
functioning of the company in the area of quality and standardization.

b. Microbiology Laboratory:
This section caries out microbial control of production Environment, Microbial analysis of raw
materials, finished products and water. They are also in-charge of treating, transferring and
deionization of production water and distillation of water used in laboratory analysis.

c. Quality Assurance:
This unit refers to the planned and systematic activities implemented in a quality system so that
quality requirements for a product will be fulfilled. They also monitor the production of any drug
starting from the dispensing section to packaging section to make sure that the product is in
good quality.
Production Department:
This department is mostly known as active department of the company because it is responsible
for ensuring quality is achieved in each production stage through the activities of in-process
checks. Basically, they are responsible for the production and packaging of drugs. It is divided
into sections and each section caries out different duties, they are.

a. Dispensary Section:

This section is the gateway for all the raw materials used in the production department, they
normally carry out weighing and dispensing of all raw materials with the aid of Electronic
weighing balances as specified in the batch operation.

b. Granulation Section:

This section is where granules are being prepared by Mixing, Milling, Drying, Sieving, Crushing
and Blending of the dispensed raw materials according to the procedure set by the quality
control to produce the required product. The machines used in granulation section includes
Rapid Mixer granulation, Multi-mill machine, Fluidized bed dryer, Vibro-Sifter and Octagonal
blender.

c. In-process section:

This section is where the dried granules from granulation is being checked for loss on drying,
disintegration test of drugs as well as the friability and weight variation of compressed tablets
and caplets. They in line with the quality control gives out the compression range of tablets and
caplets and filling range of capsules. They also carry out the leak test on blistered drugs.

d. Compression Section:

Compression is the process by which granules are turned into solids form which can be circular
called “tablets” or oblong called “caplets”. This is done with the aid of a compressing machine
that consists of a die and punch.

e. Encapsulating section:

This is where empty gelatine is filled with drug powder with the aid of capsulation machine.

f. Coasting Section:
This is where some tablets that cannot be taken directly are being coated with coating machine
some of these drugs include, ferrous sulphate, and Ibuprofen.

g. Blistering section:
This is where compressed, coated and capsulated drugs are being blistered. I.e. putting them
into polyvinyl chloride (PVC) and aluminium foil with the aid of blistering machine.

h. Packaging Section:

This is where the blistered drugs are taken to, for packaging into packets and also shrink
wrapped using shrink wrapping machine.

Store Department:
This is of different unit depending on what is being stored. They include:

a.   Quarantined Raw Material Store:


This is where received raw materials are kept to be analysed by the quality control
officers i.e. the chemists and microbiologists
.
b. Approved Raw Material Store:
Here raw materials that have been certified by the Quality control personnel are kept
here.

c. Quarantined Finished Product Store:


This is where packaged drugs are kept pending till after QC’s finished product analysis.

d. Finished Product Store:


Here approved finished products are kept before it will be conveyed to the market.
Transport Department
This department is in charge of conveying of finished products to the market outlets
and also conveying raw materials required by the company.
Security Department
This department makes sure that unauthorized product does not leave the company
and are not taken into the company. They also ensure that only persons authorized by
the management enter the company.

GOOD MANUFACTURING PRACTICES OF THE COMPANY

This can be analysed in three forms


:
1. Dress Code/ Personnel Hygiene.
· Washing of hands and face before entering the production area.
·Clothing yourself with the overall to ensure that the dust probably in your street clothe
· The head is covered to ensure that hair does not enter the product.
· Bathing and use of roll on, no hard-smelling perfume.
· Use of Ornaments is not allowed.
· No edible thing should be taken into production area.
2. Product handling
·      Products are not to be touched with bare hand.
·      A product is handled at a time.
·     The product must be put in keg
·     Kegs are to be covered to avoid drug reactions.
·     Before any keg is used, old labels must be removed and a new one placed.
·    If at the course of operation, the machine develops fault, protect the product by
covering before inviting the engineering team.

3.  Operational System
·   An operator is meant to wear a good foot wear to avoid electric shock.
·   A machine should be test run for some minutes before starting the process.
·   Check the parts to ensure they are functioning properly.
·   Ensure proper alignment of the machine pulley and fan belt.
·   Ensure that your overall does not come in contact with any fast-moving part of the
machine to
    avoid accident.
·   Lubricate your machines daily before use to avoid wear and tear.

LABORATORY SAFETY
i.) Non-laboratory staff is not allowed to touch any reagent or equipment in the
laboratory.
ii) Always put on your lab coat with cap and slippers while in the laboratory.
iii ) All laboratory staff must know how to use fire extinguisher.
iv) The entire storage container must be labelled with name, concentration, dates and
signature. The entire unlabelled container should be discarded.
V.) No answering of phone calls in the laboratory.
vi) Food or beverages are not to be stored or consumed in the laboratory.
vii.) All acids must be stored in a glass container
viii.) All materials not under use should be off the reagent desk.

PRODUCTS:
IT’S ACTIVE  INGRIDENT AND INDICATION/USE
BRAND NAME NAME DOSES

ARECENAC-P ACELOFENAC TAB 100MG

ACTPAR PARACETAMOL TAB 500MG/100MG

ARCLOX AMOXICILLIN CAP 250 MG

INXITY ETIZOLAM Tab 0.5 mg

MAPH 4 MAGALDERATE -SIMETHICONE SYRUP 5 ML

METME SR METFORMIN TAB 500MG

EQUIPMENTS UTILIZED DURING INDUSTRIAL TRAINING


CHEMISTRY LABORATORY SECTION
This is a subsection of the quality control department where chemical analysis of both
raw and finished pharmaceutical product is carried out. Some of the equipment used
include:

3.1.1    UV-Spectrophotometer
UV-visible spectrophotometer is one of the most frequently employed equipment in
pharmaceutical analysis. It involves measuring the amount of ultraviolet or visible
radiation absorbed by a substance in solution. In Pasco pharmaceuticals, uv-visible
spectrophotometer was used mainly during the analysis of paracetamol tablet and
diclofenac caplet. Spectrophotometric technique is simple, rapid, moderately specific
and applicable to small quantities of compound. The law that governs the quantitative
spectrophotometric analysis is the beer-Lambert law which states that the quantity of
light absorbed by a substance dissolved in a non-absorbing solvent is directly
proportional to the concentration of the substance and the path length of the light
through the solution. This law is accurate for dilute solutions.

Fig.3.1: UV-Spectrophotometer

Digital Analytical Weighing Balance:


This is equipment used to measure small mass in the sub-milligram range. The
measuring pan of an analytical balance (0.1mg) is inside a transparent enclosure with
doors so that dust does not settle in. It is calibrated every day so as to get accurate
readings during measurement

Fig.: Digital Analytical Weighing Balance

Top-load Balance
This is equipment used to determine the weight or mass of an object.
Fig.: Top-load Balance
Water Bath
This is equipment used for regulating the
Temperature of a substance subjected to heat. The vessel is surrounded by
Another vessel containing water which can be kept at a desired temperature. In Pauco
Pharmaceuticals water bath is used to heat those substances which cannot be
heated directly on burses burner.

Fig.: Water Bath


Melting Point Apparatus
The melting point apparatus is an instrument used to determine the melting point of a
substance. In Paulo pharmaceuticals it
is used during analysis to check the melting point of various raw materials.
The sample is loaded into a sealed capillary (melting point capillary) and then
placed in the apparatus, the sample is then heated and as the temperature
increases the sample is observed to determine when the phase changes from solid
to liquid occurs. This temperature range that is determined can then be
averaged to be the melting point of the sample.

Fig.: Melting Point Apparatus

MICROBIOLOGY SECTION:
This is also a subsection of the quality control department.

~ pH Meter
The PH meter is an electronic device used for
measuring the PH of a liquid. In Pauco pharmaceuticals the PH meter is
calibrated every day before each measurement and the reason for this is that
the glass electrode does not give a reproducible E.M.F over longer periods of
time. Buffer 4 and buffer 7 solutions are mainly used for this calibration.
A PH meter measures essentially the electro-chemical potential between a known
liquid inside the glass electrode and the unknown liquid outside.

Fig: ph Meter

~Autoclave
An autoclave is a pressure chamber used to sterilize
equipment’s and supplies by subjecting them to high pressure standard steam at
121 c (249 F) for around 15-20minutes.The principle in autoclaving is
0 0

sterilizing the material using temperature steam and pressure. The high
temperature will kill most microorganisms because they cannot tolerate the
temperature. The pressure would cause penetration of membrane walls of
organisms, disruption or breaking the walls, forcing the steam into them and
screwing up the osmotic pressure.

~Incubator
An incubator is a device used to grow and
maintain microbiological culture or cell cultures.
It works on the principle that if optimum conditions of temperature and pressure
are provided to organism, then they can grow at their maximum rate.

Fig.: Incubator
~IN-PROCESS SECTION
This section deals mainly with the checking of
drugs at intervals during production to make sure they correspond to the
company product specification.

~ Moisture Analyser
This is mainly used to measure the moisture content
of granules especially during the final drying of production.
Fig. : Moisture Analyzer

~ Leak Test Apparatus


This is equipment used to check the integrity of blistered tablet. This is carried
out at intervals on blistered tablet so as to make sure that blistered tablet
do not allow water to pass through them.

Fig. : Leak Test


Apparatus

~ Friability

Testing Machine Friability test is carried out with an instrument called FRIBILATOR. A
friability testing apparatus should stimulate the condition that the product will be
exposed to during the process of production e.g. during blistering. This test is a method
to determine physical strength of uncoated tablets upon exposure to mechanical shock.
The instrument is shown below.

Fig: Friability Testing Machine (Friabilator)


~Hardness Tester
This is used to test the breaking point of a tablet under conditions of storage,
transportation and handling before usage.

Fig: Hardness Tester

~ Disintegration Tester
Disintegration is the time required for the tablet to break into particles. This test
measures only the time required under a given set of condition for a group of tablets to
disintegrate into particles.

Fig.: Disintegration Tester

~PRODUCTION SECTION
Production is the conversion of raw materials to finished goods to satisfy?
Consumer wants. Equipment used here include:

-Rapid Mixer Granulator (RMG)


This is the machine in which the active ingredients and some excipients are mixed. The
first mixing is called dry mixing.
Fig: Fluid Bed Dryer (FBD)
-Multi Milling Machine
This machine mills the powdered materials into granules giving it the desired size. It
does this milling with meshes which are of different size.

Fig: Multi Milling


Machine
-Blender
This is the final stage in the granulation section. This stage is where the
lubricants for the drugs are added and blended together with the granules.
-Compression Machine
This is used in convert prepared granules into consumable form which can be tablets
or caplets.

Fig: Compression Machine

-Blistering machine
This is used in the blistering of consumable
solid
dosage forms i.e. tablet, caplets and
capsules to protect them against moist
and particles.

Fig: Blistering machine


-Distiller
This is used in distillation of water for analytical and coating purposes. Distiller functions
using boiling, evaporation and condensation techniques. The water obtained is referred
to as distilled water.

Fig: Distiller

                                      

Different types of tablet Coat


~PACKAGING
Packaging is defined as a technique which allows containment of pharmaceutical
product from the time of production in a unit its use. Role of pharmaceutical packaging
is to provide lifesaving drugs, surgical device, blood & blood products, powders,
poultices, liquid & dosage forms, solid &semisolid dosage forms.

TYPES OF PACKAGING
 Blister packaging:
 Alu-Alu packaging
 Strip packaging

 Blister packaging:   
This primary component of a blister pack is cavity or pocket made from a formable wed,
usually a thermoformed plastic. This usually has a blacking of paperboard or a seal of
aluminium foil or plastic
 Alu-Alu packaging:
This packaging is an optimized combination of aluminium foil and polymeric film with the
aluminum layer sandwiched between an inner sealable polymeric film and other
supportive malleable film
 Strip packaging:
  It is an alternative form of a unit dosage.it is a method of enclosed the article
concerned between the two web of material so that each is compartment

CONCLUSION
Curadev Pharma Pvt Ltd in NOIDA Sector 84, It was a
challenging place for student to do their training. I have
gained a wide knowledge of technical job scope and also
the technical work from my superior and colleagues from
other departments.
It was an advantage for me to be in the R&D division
where I have boosted up my skill and abilities. the
conclusion that I can make is Curadev Pharma Pvt Ltd is
the right place for student do their industrial training.
LLOYD INSTITUTE OF MANAGEMENT AND TECHNOLOGY (PHARM)
11, Knowledge Park-II, Gr. Noida-201308
website: lloydpharmacy.edu.in

HOSPITAL / INDUSTRIAL TRAINER FEEDBACK FORM


Dear Sir,
Many Students of our Institute have been/are being trained by you. We are thankful to you for
providing them training at your prestigious Organization.
We shall very much appreciate and be grateful to you if you can spare some of your valuable
time to fill up this feedback form. It will help us to improve the Institute further.
Thanking you.
Yours sincerely,
Dr. Vandana Arora

Name and Address of the Company-CURADEV PHARMA PVT LTD B87 SECTOR-83
NOIDA UTTAR PRADESH 201305
…………………………………………………………………………
Department -
PRODUCTION……………………………………………………………………………………
……………….
Number of Students undergone Training-10
………………………………………………………………………
Name of the student whose performance is evaluated in this
Performa……………………………………..
Students’ Feedback: Kindly grade the following aspects on a scale of 1-5 (1 being the lowest
and 5 being the highest)
I. Theoretical Knowledge 4

II. Practical Skills 4

III. Instrument Handling 3

IV. Communication Skills 4

V. Ability to work in a Team 4

VI. Professional ethics


3
(Punctuality, Discipline and sincerity)

Additional Remarks-I WAS DOING THERE INTERNSHIP TOGETHER TEAM WITH


SINCERITY AND DISCIPLINE AS WELL AS PUNCTUALITY.
………………………………………………………………………………………………………
……………………………………………………………………………………

Date: Signature

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