The document describes Juhi Sharma's internship report on her experience working in the Quality Control laboratories at IPCA Laboratories Ltd. in Kandla, India. It discusses her dedication to the internship and thanks her supervisors for their guidance. It provides details about IPCA Laboratories, including information about the company, its products, facilities, and quality control testing processes and equipment used.

1. INTERNSHIP
REPORT
INTERSHIP AT
IPCA LABORATORIES LTD. (KANDLA)
INTERSHIP BY
JUHI SHARMA
STUDENT ST. XAVIER COLLEGE

2. DEDICATION AND WORK TO IPCA
 WITH GREAT PLESURE I AM SUBMITTING MY INTERNSHIP
REPORT ON QUALITY CONTROLLABORATARIES IN IPCA
(KANDLA).
 I GOT THE OPPORTUNITY TO WORK AT INDIA’S BEST
PHARMACEUTICAL COMPANY
 I FOUND THE EXPERIENCE TO BE QUITE INTERESTING AND
UNDER THE GUIDANCE OF MY SUPERVISORS AND WITH HELP
OF MEMBERS OF THE DEPARTMENT.
 I HAVE DEDICATED MY INERNSHIP TO MY TEACHERS WHO
FOUND SUCH ABILITY IN ME.

3. ACKOWLEDGE MENT
 KNOWLEDGE HAS NO BOUNDARIES AND THERE IS NO END TO
IT. THIS IS WHAT CAME TO MY MIND WHILE PREPARING THIS
REPORT.
 GOOD EXPERIENCE,TAKING TRAINING IN THE INDIAN
PHARMACEUTICAL COMBINE ASSOCIATION LTD. THE WHOLE
STAFF WAS COOPERATIVE AND HELPFUL.
 I SENCERELY EXPRESS MY THANKS AND GRATITUDE TO THE
HONOURABLE QC MANAGER ANAND CHOBEY SIR AND
KALPESH SIR WHO PROVIDED ME OPPOERTUNITY OF
INTERSHIP AND WORK UNIQUE ORGANISATION.
 I AM OBLIGED TO INTEND MY THANKS TO ALL STAFF MEMBERS
OF IPCA LTD. FOR EXTRAORDINARY GUIDANCE AND
TREMENDOUS COOPERATION THROUGHOUT THE TENURE OF
INTERSHIP.

4. IPCA LABORATORIES
 IPCA Laboratories is an international pharmaceutical
company based in Mumbai, India. It produces Theo bromine,
Acetylthiophene, and P-Bromo Toluene as Active Pharmaceutical
Ingredients (APIs). Ipca sells these APIs and their intermediates
world over.It produces more than 150 formulations that include
oral liquids, tablets, dry powders, and capsules. The various kinds
of drug intermediates that the company manufactures include
Theo bromine, Acetylthiophene, and P- Bromo Toluene and
promotes over 36 countries of Asia, Africa, CIS, and South
America, including Cambodia, Kazakhstan, Kenya,
Mauritius, Myanmar, Nigeria, Oman, Russia, Sri Lanka, Sudan,
Tanzania, Ukraine, Vietnam and Yemen. The main activities of
company are to produce and market pharmaceuticals and drugs.
The various products of the company include formulations, drug
intermediates, and active pharmaceutical ingredients .

5. IPCA LABORATORIES
 Type Public company
 Traded as BSE: 524494NSE: IPCALAB
 Industry Pharmaceutical
 Founded 19 October 1949 (Mumbai)
 Founder K.B. Mehla, Dr. N.S. Tibrawala
 Headquarter Mumbai, India
 Area served World wide
 Key people Premchand Godha, MD, Mr. AK Jain, JMD
 Products Pharmaceuticals, drugs
 Revenue ₹15.59 billion(US$240 million)
 Number of employees 12000 (2015)
 Subsidiaries CCPL Software, Ipca Traditional Remedies
 Website www.ipcalabs.com

6. QUALITY CONTROL DEPARTMENT
 Quality control (QC) is a procedure or set of procedures intended to ensure that a
manufactured product or performed service adheres to a defined set of quality
criteria or meets the requirements of the client or customer.
 QC is similar to, but not identical with, quality assurance (QA). QA is defined as a
procedure or set of procedures intended to ensure that a product or service under
development (before work is complete, as opposed to afterwards) meets specified
requirements. QA is sometimes expressed together with QC as a single expression,
quality assurance and control (QA/QC).
 In order to implement an effective QC program, an enterprise must first decide
which specific standards the product or service must meet. Then the extent of QC
actions must be determined (for example, the percentage of units to be tested from
each lot). Next, real-world data must be collected (for example, the percentage of
units that fail) and the results reported to management personnel. After this,
corrective action must be decided upon and taken (for example, defective units must
be repaired or rejected and poor service repeated at no charge until the customer is
satisfied). If too many unit failures or instances of poor service occur, a plan must be
devised to improve the production or service process and then that plan must be put
into action. Finally, the QC process must be ongoing to ensure that remedial efforts,
if required, have produced satisfactory results and to immediately detect
recurrences or new instances of trouble.

7. Quality control test for material by qc
department
 For different material and dosage different test are
performed
 Test for raw material.
 For testing of raw material following test are performed according to SOP or
reference by suppliers.
 Description or physical appearance
 Solubility test
 Identification test
 Ph test
 Viscosity test
 Assay (percentage purity)
 LOD/LOCS ON DRYING

8. DIGITAL FLOROMETER-
PHOTOFLUROMETER
 A fluorometer or fluorimeter is a device used to
measure parameters of fluorescence: its intensity
and wavelength distribution of emission
spectrum after excitation by a certain spectrum of
light. These parameters are used to identify the presence
and the amount of specific molecules in a medium.
Modern fluorometers are capable of detecting fluorescent
molecule concentrations as low as 1 part per trillion.
 Fluorescence analysis can be orders of magnitude more
sensitive than other techniques. Applications
include chemistry/biochemistry, medicine, environment
al monitoring. For instance, they are used to
measure chlorophyll fluorescence to
investigate plant physiology.

9. DIGITAL FLOROMETER-
PHOTOFLUROMETER

10. KARL FISCHER MOISTURE TITRATOR
 Karl Fischer titration is a classic titration method in analytical
chemistry thatuses coulometric or volumetric titration to determine trace amounts
of water in a sample. It was invented in 1935 by the German chemist Karl Fischer. Today,
the titration is done with an automatized Karl Fischer titrator.
 The main compartment of the titration cell contains the anode solution plus the analyte.
The anode solution consists of an alcohol (ROH), a base (B), SO2 and I2. A typical alcohol
that may be used is methanol or diethylene glycol monoethyl ether, and a common base
is imidazole.
 The titration cell also consists of a smaller compartment with a cathode immersed in the
anode solution of the main compartment. The two compartments are separated by an
ion-permeable membrane.
 The Pt anode generates I2 when current is provided through the electric circuit. The net
reaction as shown below is oxidation of SO2 by I2. One mole of I2 is consumed for each
mole of H2O. In other words, 2 moles of electrons are consumed per mole of water.
 B·I2 + B·SO2 + B + H2O → 2BH+I− + BSO3BSO3 + ROH → BH+ROSO3
−The end point is
detected most commonly by a bipotentiometric method. A second pair of Pt electrodes
are immersed in the anode solution. The detector circuit maintains a constant current
between the two detector electrodes during titration. Prior to the equivalence point, the
solution contains I− but little I2. At the equivalence point, excess I2 appears and an abrupt
voltage drop marks the end point. The amount of charge needed to generate I2 and reach
the end point can then be used to calculate the amount of water in the original sample.

11. KARL FISCHER MOISTURE TITRATOR

12. LEAK TEST APPRATUS
 The leak is a flow or liquid or gas from the wall of a
vessel, container or packet due to various types of
imperfections such as crack, hole or bad seal. The leak
test can be performed by providing a vacuum pressure to
generate the flow. The leaks can be determined from
higher pressure to lower pressure. Leak, most of the
times pictures as a going pressure from inside an object
towards the outside in atmospheric pressure. On the
other hand, the leak can also be generated from the
atmosphere to inside an evacuated object. But it can be
observed easily using high-quality of leak test
apparatus, but the units and terminology of testing are
totally based on the type of testing instrument.

13. LEAK TEST APPRATUS

14. PRINCIPLE OF UVVISIBLE SPECTROMETER
 Ultraviolet–visible spectroscopy or ultraviolet-
visible spectrophotometry (UV-Vis or UV/Vis)
refers to absorption spectroscopy or reflectance
spectroscopy in the ultraviolet-visible spectral region.
This means it uses light in the visible and adjacent
ranges. The absorption or reflectance in the visible range
directly affects the perceived color of the
chemicals involved. In this region of the electromagnetic
spectrum, atoms and molecules undergo electronic
transitions. Absorption spectroscopy is complementary
to fluorescence spectroscopy, in that fluorescence deals
with transitions from the excited state to the ground
state, while absorption measures transitions from the
ground state to the excited state.[1]

15. UVVISIBLE SPECTROMETER

16. MOISTURE ANALYSER
 Sartorius Moisture Analysers are designed for at-line
on-line use in the laboratory. They provide a non-
destructive measurement, determining moisture
content without regular wet chemistry. Sartorius
moisture analysers offer a fast alternative to the oven
dryer.

17. MOISTURE ANALYSER

18. AUTOMATIC POLARIMETER
 polarimeter is a scientific instrument used to
measure the angle of rotation caused by
passing polarized light through an optically
active substance.
 Some chemical substances are optically active, and
polarized (uni-directional) light will rotate either to
the left (counter-clockwise) or right (clockwise) when
passed through these substances. The amount by
which the light is rotated is known as the angle of
rotation. The angle of rotation is basically known as
observed angle.

19. AUTOMATIC POLARIMETER

20. DISSOLUTION APPRATUS
 In the pharmaceutical industry, drug dissolution testing is routinely
used to provide critical in vitro drug release information for
both quality control purposes, i.e., to assess batch-to-batch
consistency of solid oral dosage forms such as tablets, and drug
development, i.e., to predict in vivo drug release profiles.[1]
 The main objective of developing and evaluating an IVIVC is to
establish the dissolution test as a surrogate for human studies, as
stated by the Food and Drug Administration(FDA). Analytical data
from drug dissolution testing are sufficient in many cases to
establish safety and efficacy of a drug product without in vivo tests,
following minor formulation and manufacturing changes (Qureshi
and Shabnam, 2001). Thus, the dissolution testing which is
conducted in dissolution apparatus must be able to
provide accurate and reproducible results

21. DISSOLUTION APPRATUS

22. DISINTEGRATION TESTER
 In the pharmaceutical industry, drug dissolution testing is routinely
used to provide critical in vitro drug release information for
both quality control purposes, i.e., to assess batch-to-batch
consistency of solid oral dosage forms such as tablets, and drug
development, i.e., to predict in vivo drug release profiles.[1]
 The main objective of developing and evaluating an IVIVC is to
establish the dissolution test as a surrogate for human studies, as
stated by the Food and Drug Administration(FDA). Analytical data
from drug dissolution testing are sufficient in many cases to
establish safety and efficacy of a drug product without in vivo tests,
following minor formulation and manufacturing changes (Qureshi
and Shabnam, 2001). Thus, the dissolution testing which is
conducted in dissolution apparatus must be able to
provide accurate and reproducible results.

23. DISINTEGRATION TESTER

24. HOT PLATE MAGNETIC STIRRER
 A magnetic stirrer or magnetic mixer is a laboratory device that employs a
rotating magnetic field to cause a stir bar (also called "flea") immersed in a liquid to
spin very quickly, thus stirring it. The rotating field may be created either by a
rotating magnet or a set of stationary electromagnets, placed beneath the vessel with
the liquid.
 Magnetic stirrers are often used in chemistry and biology, where they can be used
inside hermetically closed vessels or systems, without the need for
complicated rotary seals. They are preferred over gear-driven motorized
stirrers because they are quieter, more efficient, and have no moving external parts
to break or wear out (other than the simple bar magnet itself). Magnetic stir bars
work well in glass vessels commonly used for chemical reactions, as glass does not
appreciably affect a magnetic field. The limited size of the bar means that magnetic
stirrers can only be used for relatively small experiments, of 4 liters or less. Stir bars
also have difficulty in dealing with viscous liquids or thick suspensions. For larger
volumes or more viscous liquids, some sort of mechanical stirring is typically
needed.
 Because of its small size, a stirring bar is more easily cleaned and sterilized than
other stirring devices. They do not require lubricants which could contaminate the
reaction vessel and the product. Magnetic stirrers may also include a hot plate or
some other means for heating the liquid

25. HOT PLATE MAGNETIC STIRRER

26. VISCOMETER
 A viscometer (also called viscosimeter) is an instrument used to
measure the viscosity of a fluid. For liquids with viscosities which
vary with flow conditions, an instrument called a rheometer is used.
Thus, a viscometer can be considered as a special type of rheometer.
Viscometers only measure under one flow condition.
 In general, either the fluid remains stationary and an object moves
through it, or the object is stationary and the fluid moves past it.
The drag caused by relative motion of the fluid and a surface is a
measure of the viscosity. The flow conditions must have a
sufficiently small value of Reynolds number for there to be laminar
flow.
 At 20.00 degrees Celsius the dynamic viscosity (kinematic viscosity
x density) of water is 1.0038 mPa·s and its kinematic
viscosity (product of flow time x Factor) is 1.0022 mm2/s. These
values are used for calibrating certain types of viscometers

27. VISCOMETER

28. REFRACTOMETER
 A refractometer is a laboratory or field device for
the measurement of an index of
refraction (refractometry). The index of refraction is
calculated from Snell's law while for mixtures, the
index of refraction can be calculated from the
composition of the material using several mixing
rules such as the Gladstone–Dale
relation and Lorentz–Lorenz equation.

29. REFRACTOMETER

30. FRIABILITY APPRATUS
 Tablet friability test apparatus are used for
determination of durability of tablets at the time of
production. The apparatus is designed to provide the
precise value of rate of abrasion and impact hardness
of the tablets. Friability is important since it affects
in particle size distribution of granules affecting
compressibility into tablet, tablet weight variation,
granule flowability. Friability is determined carrying
out Tumbler Test or using Friability Tester ( Roche
Friabilator ) and % loss is determined.

31. FRIABILITY APPRATUS

32. COOLED INCEBATOR
 In biology, an incubator is a device used to grow and maintain microbiological
cultures or cell cultures. The incubator maintains
optimal temperature, humidity and other conditions such as the carbon
dioxide (CO2) and oxygen content of the atmosphere inside. Incubators are essential
for a lot of experimental work in cell biology, microbiology and molecular
biology and are used to culture both bacterial as well as eukaryotic cells.
 Louis Pasteur used the small opening underneath his staircase as an incubator.
Incubators are also used in the poultry industry to act as a substitute for hens. This
often results in higher hatch rates due to the ability to control both temperature and
humidity. Various brands of incubators are commercially available to breeders.
 The simplest incubators are insulated boxes with an adjustable heater, typically
going up to 60 to 65 °C (140 to 150 °F), though some can go slightly higher
(generally to no more than 100 °C). The most commonly used temperature both for
bacteria such as the frequently used E. coli as well as for mammalian cells is
approximately 37 °C, as these organisms grow well under such conditions. For other
organisms used in biological experiments, such as the budding yeast Saccharomyces
cerevisiae, a growth temperature of 30 °C is optimal

33. COOLED INCEBATOR

34. PH METER
 A pH Meter is a scientific instrument that measures
the hydrogen-ion activity in water-based solutions,
indicating its acidity or alkalinityexpressed
as pH.[2] The pH meter measures the difference
in electrical potential between a pH electrode and a
reference electrode, and so the pH meter is
sometimes referred to as a "potentiometric pH
meter". The difference in electrical potential relates
to the acidity or pH of the solution.[3] The pH meter
is used in many applications ranging from laboratory
experimentation to quality control.[4]

35. PH METER

36. ANALYTICAL BALANCE
 An analytical balance (often called a "lab balance") is a class of
balance designed to measure small mass in the sub-milligram
range. The measuring pan of an analytical balance (0.1 mg or better)
is inside a transparent enclosure with doors so that dust does not
collect and so any air currents in the room do not affect the
balance's operation. This enclosure is often called a draft shield. The
use of a mechanically vented balance safety enclosure, which has
uniquely designed acrylic airfoils, allows a smooth turbulence-free
airflow that prevents balance fluctuation and the measure of mass
down to 1 μg without fluctuations or loss of product. Also, the
sample must be at room temperature to prevent
natural convection from forming air currents inside the enclosure
from causing an error in reading. Single pan mechanical
substitution balance maintains consistent response throughout the
useful capacity is achieved by maintaining a constant load on the
balance beam, thus the fulcrum, by subtracting mass on the same
side of the beam to which the sample is added

37. ANALYTICAL BALANCE

38. CERTIFICATE