TRAINING REPORT

A training report submitted to

L.J. INSTITUTE OF PHARMACY

In Partial Fulfilment of The Requirement for The Subject

“Practice School”
For B.Pharm. Semester7 for The Academic Year 2023-24
(As Per Gujarat Technological University Curriculum)

SUBMITTED BY: -

DHRUVIK SHAH
L. J. INSTITUTE OF PHARMACY, SARKHEJ
ENROLLMENT NO: 202270290005
(2023-24)

Under The Guidance of

MS. HEMAL BHAVSAR

(ASSISTANT PROFESSOR)
 TRAINING REPORT

CERTIFICATE

This is to certify that the training report/review submitted here with entitled “INDUSTRIAL
TRAINING REPORT” by MR. DHRUVIK SHAH, EnrollmentNo.202270290005 student
of L.J INSTITUTE OF PHARMACY (Institute code 227), as part of the requirement that
is to be fulfilled to pass the subject “PRACTICE SCHOOL” for B.PHARM SEMESTER
7,foracademicyear2023-24, as per the GUJARAT TECHNOLOGICAL UNIVERSITY
norms. The training report/review is verified and is found satisfactory.

Date of Submission:

Place:

Name of Guide: _________________

Signature of Guide: _____________

Signature of Principal Seal of Institute

(Dr. Shreeraj Shah)

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TRAINING CERTIFICATE

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ACKNOWLEDGEMENT

It is a great pleasure & privilege to have an opportunity to get training in SWISS PHARMACEUTICAL-
AHMEDABAD& submitting a report on Industrial Training. It was a great chance
for my personal and professional development. Therefore, I consider myself as a very privileged individual
as I was provided with such a wonderful opportunity to gain the knowledge and explore how the industry
works at different platform.

I feel in debted to the principal of our college, DR. SHREERAJ SHAH, for taking out time and always
being so supportive and giving me appropriate advice whenever needed.

I would like to express my deepest admiration and respect to my supervisor MS. HEMAL BHAVSAR, who
in spite of being extraordinarily busy with her duties, took time out to hear, guide and advise by giving me
proper suggestions for the training throughout this period. I am honored that she saw potential in me and
took my report to another level.
I am also grateful to L.J. INSTITUTE OF PHARMACY, GUJARAT TECHNOLOGICAL
UNIVERSITY and PHARMACY COUNCIL OF INDIA for providing us the opportunity to get trained in
diverge fields by gaining more knowledge and developing ourselves professionally and making us
understand the value of pharmacy profession.

Sincerely,
DHRUVIK SHAH
Sem-7

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PREFACE

The objective of the training is to get detail about the manufacturing process and its operation
carried out in industry. Training is very important as it helps to develop the technical,
commercial and communicational skill in the concerned field.

Training period provides detailed study of unit process, unit operation instrumentation,
maintenance and safety. It also develops regularity, discipline co - ordination skill in the trainee.

I am very glad to present our training report at the end of 21 Days training at SWISS
PHARMACEUTICAL as a part of our curriculum being conducted. In this report, I try to cover
all the fields in this industry and, I have represented the knowledge I obtained during this
training.

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CONTENTS
•MISSION..........................................................................................................................................7
1.DEPARTMENTS AT SWISS PHARMACEUTICAL WORKS LIMITED...................................8
2.PRODUCTS OF SWISS PHARMACEUTICAL...........................................................................9
3.PRODUCTION DEPARTMENT..................................................................................................10
4.QUALITY CONTROL DEPARTMENT......................................................................................11
5.INSTRUMENTS............................................................................................................................13
5.1 RAPID MIXER GRANULATOR............................................................................................13
5.2 V BLENDER (CONE BLENDER) .........................................................................................15
5.3 TABLET COMPRESSION MACHINE.....................................................................................17
5.4 WEIGHING BALANCE..........................................................................................................19
5.5 DISSOLUTION APPARATUS................................................................................................20
5.6 DISINTEGRATION APPARATUS.........................................................................................22
5.7 HIGH PERFORMANCE LIQUID CHROMATOGRAPHY...................................................24
5.8 PH METER...............................................................................................................................26
5.9 MELTING POINT....................................................................................................................27
5.10 FRIABILITY APPARATUS..................................................................................................28
6.QUALITY CONTROL..................................................................................................................29
7.CONCLUSION..............................................................................................................................33
8.REFERENCE................................................................................................................................34

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•VISION:
1.To finish the journey of being the most trusted name in the pharmaceutical industry, which we started two
decades back.

2.To keep on providing new age solutions for the healthcare industry.

3.To mark our presence in the highly regularised pharmaceutical

markets such as USA..

•MISSION:
1.To achieve highest end-consumer satisfaction by providing quality
products at affordable prices.
2. To provide treatments for the ORPHAN DIEASES.
3.To provide new solutions for the age-old and new disorders and
diseases by comprehensive Research and Development work.
4.To remain up to date with the latest knowledge and technology in
the pharmaceutical industry.
And above all, our highest goal is to strengthen the health of the
country and the entire world by our range of products andservices.

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1.DEPARTMENTS OF SWISS PHARMACEUTICAL WORKS

LTD.

1.HUMAN RESOURCES (HR)

2.INFORMATION TECHNOLOGY (IT)

3.R&D (RESEARCH & DEVELOPMENT)

4.F&D (FORMULATION & DEVELOPMENT)

5.PRODUCTION DEPARTMENT

6.QUALITY ASSURANCE (QA)

7.QUALITY CONTROL (QC)

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2.PRODUCTS OF SWISS PHARMACEUTICAL

• AYURVEDIC AND HERBAL
Bresto
Kanip
And more
• TABLET AND CAPSULE
Norfloxacin tablet
Haloperidol tablet
Alprozolam tablet
And more
•INJECTABLE DRUGS
Gaticin injection
Decalon injection
Cefozone injection
And more
•SPECIAL PRODUCT
Glucose tablet
Tadalafil tablet
Desmopressin nasal drops
And more

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3.PRODUCTION DEPARTMENT
1.GOOD MANUFACTURING PRACTICE (GMP):
•Good Manufacturing Practice (also called 'current Good Manufacturing Practice', cGMP') is a part of Quality
Assurance this ensures that products are consistently produced and controlled to the quality standards appropriate to
their intended use as required by the marketing authorization or product specification.
•Additionally, GMP requires that all manufacturing and testing equipment has been qualified as suitable for use, and
that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in
the drug manufacturing process have been validated (according to predetermined specifications), to demonstrate that
they can perform their purported function(s).
•>>GMP is concerned with both production and quality control. Requirements of GMP ensure that:
•All manufacturing processes are clearly defined, systematically reviewed in the light of experience and are shown to
be capable of manufacturing medicinal products of the required quality consistently as per recommended
specifications.
•Validation is required for their manufacturing processes.
•All necessary facilities including qualified and trained personnel, adequate premises and space, suitable equipment
and services, correct materials, containers and labels; approved procedures and instructions and suitable storage and
transport facilities may also be provided for carrying out GMP.
•The instructions and procedures are to be written in an instructional form in clear and unambiguous language. The
operators should be trained, and the records must be maintained during manufacturing. This shows that all the steps
related to defined procedures were taken into consideration. Thus, the quantity and quality of the product remain the
same in all the concerned batches.
•If any significant deviations occur, it must be recorded and investigated. Similarly, records of manu-fracturing
including distribution enable the complete history of a batch. This is retained in a comprehensible and accessible form.
The distribution (wholesaling) of the products should also minimize any risk to its quality.
•The system must be available to recall any batch of product, from sale or supply. If any complaint lodged about
marketed products, the causes of quality defects should be investigated, and appropriate-ate measures can be taken so
that the defective products must not be produced in future
•The regulatory agencies of different countries like the FDA in the US are authorized to conduct unannounced
inspections. FDA routine domestic inspections are usually unannounced but must be conducted according to 704(A) of
the FD&C Act (21USC374).

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4.QUALITY CONTROL DEPARTMENT

1. QUALITY CONTROL SYSTEM

•DEFINITION
>ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality
requirement.
>It is that part of GMP concerned with sampling, specification & testing, documentation& release
procedures which ensure that the necessary & relevant tests are performed & the product is released for use
only after ascertaining its quality.
•RESPONSIBILITIES
>QC is responsible for the day-to-day control of quality within the company.
>This department is responsible for analytical testing of incoming raw materials and inspection of packaging
components, including labelling.
>They conduct in-process testing when required, perform environmental monitoring, and inspect operations
for compliance.
>They also conduct the required tests on finished dosage form.
>QC plays a major role in the selection of qualified vendors from whom raw materials are purchased.
Testing of representative samples is required, and in many cases, an audit of vendor's operations is necessary
to determine their suitability and degree of compliance with GMPs prior to their being approved. >The
environmental areas for manufacturing of various dosage forms are tested and inspected by QC department.

2. GOOD LABORATORY PRACTICES (GLP)

> Quality Control System works under GLP guidelines.
->Good Laboratory Practice is defined in the OECD Principles as: -
>"A quality system concerned with the organizational process and the conditions under which non-clinical
health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.
>The purpose of these Principles of Good Laboratory Practice is to promote the development of quality test
data and to provide managerial tool to ensure sound approach to the management, conduct, reporting and
archiving, of laboratory studies.

>The principles may be considered as a set of criteria to be satisfied as a basis for ensuring the quality,
reliability and integrity of studies, the reporting of verifiable conclusions, and the traceability of data.
>Consequently, the principles require institutions to allocate roles and responsibilities in order to improve

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the operational management of each study, and to focus on those aspects of study execution (planning,
monitoring, recording, reporting, archiving) which are of special importance for the reconstruct ability of the
whole study.
>Since all these aspects are of equal importance for compliance with the Principles of GLP, there cannot be
any possibility of using only a choice of requirements and still claiming GLP compliance.
>No test facility may thus rightfully claim GLP compliance if it has not implemented, and if it does not
comply with, the full array of GLP rules.

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5.INSTRUMENTS
5.1 RAPID MIXER GRANULATOR

FIGURE 1. RAPID MIXER GRANULATOR (RMG)

Rapid mixture granulator (RMG) is used in mixing, agitation, and shear mixing (to break internal molecular
force). RMG is used in pharmaceuticals to make granules. The components of the RMG (impeller and
chopper) are highly responsible for the WET GRANULATION process.
• COMPONENTS OF RMG:
> Rapid mixture granulator components like mixing chamber, impeller, chopper, Discharge port, Filter,
pursuing air, and port provided for solution inlet.
> Impeller and chopper are responsible for mixing and break granules mass. Discharge points are connected
horizontally at the lower part of RMG. The discharge point is operated automatically with the help of a
pneumatic pump (required 3-5 kg/cm2 compressed air pressure)
> The filter is placed with a vent air filter to remove purging air and retained granules inside. Purging air is
supplied below from the impeller to prevent stickiness in the granules to the impeller and helps prevents
contamination.
> Pursing Air Pressure ranges 5-6 kg.
> There are two motors, one for impeller and another one for chopper

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• WORKING PRINCIPLE OF RMG:

> Rapid mixture granulator works on agitation, tumbling. The impeller is responsible for uniformly mixing
wet granules, and the chopper helps in a break or reduced particle size. At the starting process or during
binder addition, the impeller and chopper generally operate at low speed. Then after the formation of wet
mass, they are operated at high speed to make the desired granule size.
> Dry mixing is done at high speed after adding all dispensed materials into RMG.

• PROCESS VARIABLE OF RMG:

> Time was taken during the mixing process.
> Speed of impeller
> Speed of chopper
> Binder solution quantity

• The Endpoint in Rapid mixture granulator:

-> A simple method for detecting endpoint is:
> Take wet granules in hand and close the fist, then open and break it throughout the thumb, called a banana
breaking method. Ampere load method ampere load on the impeller and chopper is displayed on PLC with
amp unit.
• ADVANTAGE:
1. Easy to operate from PLC panel
2. Required less time for clean and easy to clean
3. Self-discharge
4. Mixing can be performed at a large scale at less time

5. Can produce Homogenous mass and later granules in less time.

• DISADVANTAGE:
1. High noise level
2. Required ample space to install
3. During the process, temperature becomes high because of friction force. 4. 4. High in cost

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5.2 V BLENDER (CONE BLENDER)

FIGURE 2. V BLENDER
• PRINCIPLE: The mixing occurs due to tumbling motion
> The V-Blender is made of two hollow cylindrical shells joined at an angle of 75° to 90°. The blender
container is mounted on trunnions to allow it to tumble. As the V- blender tumbles, the material
continuously splits and recombines, with the mixing occurring as the material free-falls randomly inside the
vessel.
• CONSTRUCTION:
> It consists of an enclosed V-shaped vessel that prevents any foreign particle to enter chamber. It is made of
either stainless steel or transparent plastic. It consists of a horizontal shaft rotated about an axis causing the
particles within the mixer to tumble over each other onto the mixture surface. The charging of material into
the V-Blender is through either of the two ends. Batches from 20 kg to 1 ton can be loaded for mixing
depending upon the size of the equipment.
• WORKING:
> The material is loaded into the blender. The recommended fill-up volume for the V-Blender is 50 to 60%
of the total blender volume. On rotation, a tumbling motion occurs. When the V- Blender tumbles, the
material divides and recombines continuously. The repetitive converging and diverging movement between
the material and the blender results in homogenous blending. The product is collected from the bottom of V.
Normal blend times are typically in the range of 5 to 15 minutes depending on the properties of a material to
be blended.

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> Blender speed can also be key to mixing efficiency. At low speeds, shear forces are less. Although higher
mixing speeds provide more shear, this can lead to greater dust resulting from the segregation of fines. There
is also a critical speed that, if approached, will considerably reduce the mixing efficiency. As revolutions per
minute increase, the centrifugal forces at the extreme points of the blender will exceed the gravitational
forces required for mixing. As a result, the powder must tend to gravitate toward the outer walls of the
blender casing. As the size of the blender increases, the rotational speed generally decreases in proportion to
the peripheral speed of the blender extreme. V-Blenders are designed to operate between 50% and 80% of the
critical speed.
• ADVANTAGES:
1. V-Blenders are therefore preferred when precise blend formulations are required.
2. They are also well suited for applications where some ingredients may be as low as five percent of the
total blend size.
3. Particle size reduction and attrition are minimized due to the lack of moving blades. Therefore, it can be
used for fragile materials
4. Loading and unloading of material is easy
5. The absence of shaft projection reduces the chances of product contamination. 6. Easy to clean
• DISADVANTAGES:
1. They require high headroom for installation and operation.

2. They are not suitable for blending particles of different sizes and densities. There are chances of
segregation of these particles at the time of discharge.
• APPLICATIONS:
1. V-Blenders are used for dry mixing. It provides efficient blending in a short time.

2. This blender is often used for pharmaceuticals. But not suited for very soft powders or granules. 3.
VBlenders are generally used for Food products, Dry Flavors. Pesticides and Herbicides, Animal feed,
Spice blends, Baby foods, and Cosmetics

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5.3 TABLET COMPRESSION MACHINE

FIGURE 3. TABLET COMPRESSION MACHINE

• PRINCIPLE:
The basic principle behind the compression machine is hydraulic pressure. The pressure is transmitted via
static fluids in all directions with the same proportion.

• TYPES OF COMPRESSION MACHINES:

Usually, there are two major types of compression machines: a)
Single Station machine
b) multi-Station machine.

• VARIOUS STAGES OF COMPRESSION PROCESS:

> There are almost four major stages in the compression process of tablets that are illustrated below:
1.Filling:
> Punch-die and lower punch are used to make the punch-die cavity. The volume of the cavity is then
determined by the position of the lower punch in the die.
2. Metering:

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> In this stage of compression of tablets, the excess material of granules is ejected out from the dye punch
section of the machine. The metering cam adjusts the required volume of tablet that is set by the operator as
per requisition.
> In this technique, the main role of lower punch allotted that move upward in such a way so that the
excessive powder than the required thrown out and the desired weight tablet can be manufactured.

3. Compression:
> Compression is the main stage of this whole process. In this process, the lower (die) and upper punch
come together to form the tablet with the help of pressure from the topside. The resultant of two punches
coming together produce a tablet.
> Other important parameters like hardness, the thickness of the tablet depends on various factors that
happened during compression. The distance between punches and pressure applied are the main two factors
that decide the thickness of the tablet and the hardness of the tablet.

4. Ejection:
> The upper punch retracts from the die cavity and rises above the turret table. Simultaneously the lower
punch rises upward and thrusts the tablet upward in the die that helps it come out of the die. The ejection
stage is ejecting the tablet from the die punch station mechanically with the continuous process. A different
container or basket is placed bottom side at a safe height to collect tablets.

• TABLETS COMPRESSION MACHINE PARTS:

> Feeder System
> Tablet Press Punches
> Tablet Press Die System
> Tablet Press Turret
> Tablet Press Machine Cam Tracks
> Tablet Press Filling Station & Weight Control
> Compression Rollers
> Tablet Press Ejection Cam
> Take-off blade and Discharge Chute
> Other Tablet Compression Machine Parts

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5.4 WEIGHING BALANCE

• TYPES OF BALANCES:
> Ultra-micro-Balance: Ultra-micro lab balances are with readability of 0.0001 mg. 0.1 µg and a maximum
weighing capacity of 2.1 g.
> Micro balance: Micro lab balances are with the readability of 0.001 mg, 1 mg, and a maximum weighing
capacity between 3.1 g and 111 g.
Semi-micro balance: Semi-micro lab balances are with a readability of 0.01 mg | 10 µg and a maximum
weighing capacity of up to 220 g.
> Analytical balance: Analytical lab balances are with a readability of
0.1 mg and a maximum weighing capacity between 60 g and 520 g.
Precision balances and scale: Precision balances and scale are with readability between 1 mg and 1 g and a
maximum weighing capacity of up to 14.2 kg.
> High-capacity balances and scales: High-capacity balances and scale are with readability of 100 mg and 1
g and a maximum weighing capacity of up to 70.2 kg.

• COMPANY: Sartorius, Mettler Toledo

• USE: To measure weight of sample.

FIGURE 4. WEIGHING MACHINE

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5.5 DISSOLUTION APPARATUS

• DEFINITION:
> Dissolution is the process in which a substance forms a solution. Dissolution testing measures the extent
and rate of solution formation from a dosage form, such as tablet, capsule, ointment, etc.

> The dissolution of a drug is important for its bioavailability and therapeutic effectiveness.

> A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to
evaluate the performance of the product.

FIGURE 5. DISSOLUTION APPARATUS

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• BASKET TYPE APPARATUS:

> It comprises of borosilicate glass and holds a capacity of up to 1000 ml. The shape is semi-hemispherical
at the bottom while its shaft is made of stainless steel. The shaft holds the cylinder basket. It is usually
referred to as a rotating basket because it rotates smoothly, and its rotating speed must be in form with the
recommended USP. The common speed limit is 100 rpm.
> Sample is withdrawn for analysis from a zone midway between the surface of the dissolution medium
and the top of the rotating cylinder, not less than 1cm from the vessel wall.

• PADDLE TYPE APPARATUS:

> This apparatus is specially made, and it comes with a coated paddle that reduces the disturbance from the
stirring. Apparently, it has a blade that comes in contact with the bottom of the shaft.
> The Paddle apparatus is designed from stainless steel. A sinker such as platinum wire is used to prevent a
capsule or tablet from floating. The paddles motor speed is usually at 40 and the paddle is kept at 37C. >
The paddle is kept in the position that specified in the current USP. It has a motor speed of 50 rpm for
capsules while it is 25 rpm for suspensions

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5.6 DISINTEGRATION APPARATUS

• DEFINITION:
> Disintegration is defined as that state in which no residue of unit under test remains on the screen of the
apparatus or, if a residue remains, it consists of fragments of disintegrated parts of tablet components parts
such as insoluble coating of the tablet or of capsule shells, or of any melted fatty substance from the

pessary or suppository or isa soft mass with no palpable core.

FIGURE 6. DISINTEGRARTION APPARATUS

• APPARATUS:
> The apparatus consists of a basket-rack assembly, a 1000 mL, low-form beaker, 138-160 mm in height and
having an inside diameter of 97-115 mm for the immersion fluid, a thermostatic arrangement for heating the
fluid between 35°C and 39 °C and a device for raising and lowering the basket in the immersion fluid at a
constant frequency rate between29 and 32 cycles per minute, through a distance of not less than 53 mm and
not more than 57 mm.

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> The volume of the fluid in the vessel is such that at the highest point of the upward stroke the wire mesh
remains at least 15 mm below the surface of the fluid and descends to not less than 25 mm from the bottom
of the vessel on the downward stroke.

> The basket-rack assembly moves vertically along its axis. There is no appreciable horizontal motion or
movement of the axis from the vertical.

• PROCEDURE:
> Place one dosage unit in each of the six tubes of the basket and if specified add a disc.
> Operate the apparatus using water as the immersion fluid unless another liquid is specified and maintain
its temperature at 35-39 °C. At the end of the specified time lift the basket from the fluid and observe the
dosage units: all the dosage units have disintegrated completely. If one or two dosage units fail to
disintegrate repeat the test on 12 additional dosage units.
> The requirements of the test are met if not less than 16 of the 18 dosage units tested are disintegrated.

• METHOD:
> Test 6 tablets or capsules either by using 2 basket-rack assemblies in parallel or by repeating the
procedure. In each of the 3 tubes place 1 tablet or capsule and, if prescribed add a disc; suspend the
assembly in the beaker containing the specified liquid.
> Operate the apparatus using water as the immersion fluid unless another liquid is specified for the
prescribed period, withdraw the assembly and examine the state of the tablets or capsules. To pass the test
all 6 of the tablets or capsules must have disintegrated.

• APPLICATIONS:
> Establishing consistency and uniformity across all batches using this method is a critical quality control
step. Each pharmacopoeia specifies its own standard conditions for the performance of disintegration
testing.
> Establishing consistency and uniformity across all batches using this method is a critical quality control
step. Each pharmacopoeia specifies its own standard conditions for the performance of disintegration
testing.

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5.7 HIGH PERFORMANCE/PRESSURE LIQUID CHROMATOGRAPHY (HPLC)

• DEFINITION:
> It is a chromatographic technique used to separate component of mixture for the purpose to identify,
quantify, or purify the individual components of the mixture.
• PRINCIPLE:
> Works on the principle of partition co-efficient.
> When 2 immiscible liquids are present, a mixture of solutes will be distributed according to their partition
co-efficient.
> The component which is more soluble in stationary phase travels slower & which is more soluble in
mobile phase travels faster.
> The stationary phase as such cannot be a liquid. Hence a solid support is used over which a thin film or
coating of liquid is made which act as stationary phase.

• Normal phase mode: • Reverse phase mode:

> Stationary phase- polar > Stationary phase- non polar >
Mobile phase- non-polar > Mobile phase- polar

FIGURE 7. HPLC

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• PROCEDURE:
> HPLC is a separation technique that involves:
> The injection of a small volume of liquid sample into a tube packed with tiny particles (3-5 micron in
diameter called stationary phase) where individual components of the sample are moved down the packed
tube (column) with a liquid (mobile phase) forced through the column by high pressure delivered by a
pump.
> These components are separated from one another by the column packing that involves various chemical
and/or physical interactions between their molecules and the packing particles
> These separated components are detected at the exit of this tube (column) by the flow-through device
(detector) that measures their amount. The output from the detector is called a liquid chromatogram.

• APPLICATIONS:
> The information that can be obtained by HPLC includes resolution, identification and quantification of a
compound. It also aids in chemical separation and purification. The other applications of HPLC include:
PHARMACEUTICAL APPLICATIONS:
> Tablet dissolution study of pharmaceutical dosages form.
> Pharmaceutical quality control.
> Drug stability
APPLICATIONS IN CLINICAL TESTS:
> Urine analysis, antibiotics analysis in blood.
> Analysis of bilirubin, biliverdin in hepatic disorders.
> Detection of endogenous Neuropeptides in extracellular fluid of brain etc.

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5.8 PH METER
> A pH meter is a scientific instrument that measures the hydrogen-ion activity in water-based solutions,
indicating its acidity or alkalinity expressed as pH. 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. The pH meter is used in
many applications ranging from laboratory experimentation to quality control.
• PRINCIPLE:
> It measures the voltage between the two electrodes. One is a glass electrode, and the other is a reference
electrode. It displays the result of that voltage that is related to the corresponding pH value. > Sometimes,
if both electrons are present, it is called the combination electrode, and they are inserted into the solution
in which pH is to be tested. These two electrodes are immersed and, after immersing these electrodes in a
solution. That H+ ion in the test solution exchange for other positively charged ions presents on the glass
ball. So, there is an action between these plus ions of the solution and H+ ions or positively charged ions
present on the glass bulb. The amplifier detects the difference in electric potential between the two
electrodes. The contrast of these potentials is called the pH unit.
• CALIBRATION:
> There is single point, two point and multi-point calibration when it comes to pH meters. Essentially this is
how many points a calibration is performed at. A single point calibration can be used when you are looking
to measure a consistent pH value with little variation. This method involves only using a single buffer
solution as a reference for calibration.
> The most common pH meter calibration is the two-point calibration and is best suited when you have a
range of pH samples. The buffer solutions should bracket your expected pH sample. In this process the pH
meter determines the slope and offset error for the actual pH electrode in use. This information then allows
the meter to adjust the mV/pH equation of the pH meter to match the characteristics of the electrode in use.
•Application of pH Meter:
> It is used in the agriculture industry to determine the pH of soil.
>It's also used to test the quality of municipal drinking water and swimming pools.
> It is used to measure the pH value of solutions in numerous chemical and pharmaceutical businesses.

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FIGURE 8. PH METER

5.9 MELTING POINT

FIGURE 9. MELTING POINT

• COMPANY: Stanford Research System
• SOFTWARE: Melt view
> OptiMelt provides a fast and accurate means of automatically determining the melting points and melting
ranges of chemical substances.
• SIMPLE OPERATION:
> OptiMelt has an intuitive front panel and is very easy to use. Simply select a start temperature, ramp rate,
stop temperature, and hit start.
Results can be easily seen from across the lab on the large LCD display. Samples can be viewed on the front
panel through a removable magnification lens.
> During a measurement, you can flag relevant events by pressing dedicated front-panel buttons. Up to six
individual temperatures can be tagged for each sample.
Interactive help is available for all functions and parameters of the instrument. Text and numerical entry
keypads are built into the touch screen interface so that no external keyboard is required.
• USE: To determine the melting point of the substances.

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5.10 FRIABILITY APPARATUS

• DEFINITION:
> Friability Test Apparatus is a precision instrument for measuring obression strength of the tablets. The
Friability Test Apparatus is designed as per IP/USP standards. The unit is equipped with two transparent
acrylic drums which rotate at a speed of 25.1 rpm.
• INSTRUMENTATION:
>Each of the two acrylic drums are provided with an arm which carries the tablets along with it up to a
predetermined height and allows them to fall from that specified height, while the drums are rotating. It is
fitted with a digital revolution counter showing the current number of revolutions for the test. A thumb
wheel switch is used to set the desired number of rotations. Provision is made to remove the lid of the
acrylic drum by unscrewing just one knob. This is available in 1 drum and 2 drum assemblies.
• USE:
> Friability tester is an apparatus which is used to check the friability of a tablet. Friability is, the condition
of being friable, describes the tendency of a solid substance to break into smaller pieces under duress or
contact, especially by rubbing.

FIGURE 10. FRIABILITY APPARATUS

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6.QUALITY CONTROL
> Quality audit means a systematic examination of a quality system.
> Quality audits are typically performed at defined intervals and ensures that the institution has clearly
defined internal quality monitoring procedures linked to effective action.
> The checking determines if the quality system complies with applicable regulations or standards. >
The process involves assessing the standard operating procedures for compliance to the regulations and
also assessing the actual process and results against what is started in the SOP.

• TYPES OF QUALITY AUDIT:

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1.INTERNAL AUDITS:
> Internal audits are carried out by an organization on its own system, procedures and facilities.
> Internal audits are also required for business prospective.
> Procedure and program of internal audit should be available.
> One possible system for internal audit is a three-tier approach.

(A) TIER ONE AUDITS:

> Carried out by the staff of a section or department itself.
> Audit will typically be short and focusing on visible such as housekeeping and documentation
> For this, auditors are usually selected based on knowledge and experience of area to be audited. Though
they should also receive some basic training.

(B) TIER TWO AUDITS:

>Typically carried out by a local QA group comprising staff independent of the department unit.
> Such audits will typically be longer but less frequent and are likely to focus on system than housekeeping.
> More exclusive training will be required for tier two auditors with more detail on quality
system and techniques.

(C) TIER THREE AUDITS:

> Carried out by corporate compliance group.
> Alternatively external consulters may be used.
> Such audits are often carried out to assess readiness for regulatory audit but may also be used to have an
expert view on specific critical activity.
> Tier three auditors are likely to be highly trained and experienced or specialist with an expert knowledge
of GMP and other regulatory requirements for pharmaceutical industry.

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2. EXTERNAL AUDITS:

a. Are carried out by company on its vendor.

b. No legal requirement to conduct the audit.

c. Need of such audit is implicit since manufactures have knowledge of their suppliers.

d. Contractors are competent to complete it in accordance with GMP. Some strong business benefits of
performing these audits are given below.

e. Building knowledge and confidence in partnership arrangement.

f. Ensuring that requirements are understood and met.

g. To enable reduction of certain activities.

h. Reducing risk of dangers.

i. They have broad practical experience of GMP and receive quality system, auditing system training
equivalent to that of ISO 9001 lead auditors.

j. They also involve specific training.

k. Many pharmaceutical industries suppliers are ISO 9001 or ISO 9002 certified their certification bodies.

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3.REGULATORY AUDITS:
1.These audits are carried out by regulatory bodies against relevant systems for manufacturer
and supply of pharmaceutical products.
2.National regulatory bodies such as medicine control agency (MCA) in the UK and FDA in USA
are statutorily responsible for carrying out such audits.
3.They may be unannounced (e.g. MCA currently performs about 10% of its UK performance like this)
4.Regulatory bodies from other countries in which products are sold may also audit companies e.g., FDA
audits European manufacturers.
5.Regulatory inspectors are extensively trained, and they are knowledgeable, qualified and having minimum
five years' experience in manufacturing operations.
ROLE OF GMP AUDITS IN QA AND QC PROGRAMS:

1. Assuring GMP compliance

2. Deleting potential problems

3. Effecting Program Improvement

4. Increasing management awareness

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7.CONCLUSION

• Industrial training is of great importance for a pharmacy student to acquire practical knowledge.
During my training period in the industry, I acquired lots of experience in Quality Assurance department
which will help me to clarify my theoretical knowledge and explore the practical knowledge.

• During my training period, I have read various SOPS's and seen many instruments and apparatus in
the industry. The highly sophisticated instruments that work precisely must be operated with intense care for
optimum use. I also acquired a lot of information regarding the latest instruments and working procedures
and how disciplined the personnel should work in the pharmaceutical industry.

• Lots of things were to be learned from this industrial training. It helped me explore my qualities and
develop myself by acquiring knowledge. It also taught me the importance of punctuality, regularity and
working environment in industries.

• My goal of attending the industrial training is fulfilled and I once again am grateful to all those who
have contributed to this success.

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8.REFERENCE
1. https://www.pharmaguideline.com
2. Int-J.Pharma.Sci.Rev.Res.,38(2),May-June-2016;Article No. 10, Page 45
3. https://www.swisspharma.in

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