Medicine produced with care, designed for your health

STADMED PRIVATE LIMITED

15, JAWPORE ROAD, KOLKATA-70074

A BRIEF REPORT ON INDUSTRIAL VISIT & TRAINING

SUBMITED BY
SAYAN GHOSH
ROLL NO: 21PT011070
BACHELOR OF PHARMACY

JIS UNIVERSITY

EMAIL ID: sayanghosh8931952@gmail.com

CONTACT NO: 8167891835

DURATION OF PERIOD: 26th DECEMBER 2023 TO 27th JANUARY 2024

 DECLARATION
I, SAYAN GHOSH, hereby declare that, the work presented in the industrial
training report entitled in "A BRIEF REPORT ON INDUSTRIAL VISIT AND
TRAINING" at Stadmed Private Limited, Kolkata.

It is an authentic record of work carried out by me during 26.12.2023 to

27.01.2024 at Stadmed Private Limited under the guidance of JIS
UNIVERSITY, AGARPARA, KOLKATA, WEST BENGAL. It is being
submitted for partial fulfilment of the requirement for the award of bachelor
degree in B. Pharm. This is not been submitted anywhere else for the award of
any other degree.

Name: Sayan Ghosh

__________________
Signature

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 CONTENTS

TOPICS PAGE NO
ACKNOWLEDGEMENT 4
PREFACE 5
ABSTRACT 6
INTRODUCTION 7
SEMI SOLID DOSAGE FORM(OINTMENTS) 8-9
SOLID DOSAGE FORMS (TABLETS) 10-15
LIQUID DOSAGE FORMS 14-15
QUALITY CONTROL DEPARTMENT 16-20
MICROBIOLOGY 21-22
STORAGE AREA 22-27
DM WATER PLANT 27
QA DEPARTMENT 27-28
DOCUMENTATION 29
ABBREVIATION 29-30
CONCLUSION 30

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 ACKNOWLEDGEMENT

First, I want to thank Mr. Rajib Chakraborty, Factory manager; Mr. Aloke
Kumar Bose, Sr. Manager Legal (Personal and Admin) who enabled this
wonderful opportunity to be a part of Stadmed Pvt Limited. We successfully
gained a lot of practical knowledge with hands on experience. The successful
compilation of the training and report was only possible due to immense help
and support of various people of industry (professional) who were there for me
whenever I needed them. I am very much privileged to spend some time in its
highly professional environment that gave me all the opportunities to learn. I am
thankful to Jahangir Sir, for introducing and coordinating our training in
different departments. I would like to thank Mr. Tanmoy Sir for his kind support
and guidance. I feel humbled and very much thankful to Sudip sir, Shovon sir,
Bappa sir, Suprakash sir and Apurbo sir for paying their valuable time and
attention to which smoothened our journey. I am thankful to different
departments of industry for giving me an opportunity and providing a great
learning atmosphere to gain hands in experience in the testing department. The
whole Technical Department has been supportive during my training. It will
surely be a lifetime remembrance for me and I feel privileged working with
such committed, elegant pharmacists and staff. I would also like to thank the
employees who helped a lot throughout my training.

NAME: Sayan Ghosh

Signature

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 PREFACE
Industry Training is a prerequisite for students in certain programs at all levels
of higher education at the Institute of Higher Learning (IPT). To increase the
level of the work of the graduates, the program was introduced to empower
industrial training competency required. These courses provide students with
learning opportunities in the workplace to receive practical experience to
improve.
This course provides exposure and experience to the students in terms of
technology development, effective communication, teamwork practices,
policies, procedures and regulations, professional perspective, and reporting.
This course will build enthusiasm and a proactive attitude among students and
increase their confidence to be an excellent coach.
In general, the Institute of Higher Learning will undergo industrial training in
the fourth semester. Industry training is done for six months in a firm or
organization that has been selected by the student or his assigned. After six
months of industrial training students must return to college to present all the
activities during industrial training.
Overall, industrial training provides many advantages and benefits to students.
During the training period, students are exposed to a variety of activities in the
field of duties, even though the job is not done entirely by students for the
purpose of security or regular students were briefed and clear guidance and
useful enough as a general knowledge, as well as exposed to the real working
environment and can learn social skills such as communication and social
relationships.
With these objectives, I have made all efforts and the necessary investigation to
submit this paper in an enlightened form in a truly short time. I have tried my
level best to eliminate errors from the paper.
As I had to complete my training within a short period so the study admits
limitation.
I visited the Stadmed Pvt. Ltd. as a part of the training programme starting from
26th December 2023 to 27th January 2022.

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 ABSTRACT
The paper proposes, briefly an introduction of Stadmed Pvt Ltd, discussed about
history, development, and services of the company. In this report I have
described in detail the whole product manufacture process and the department
of manufacturing and its management, store room and testing area etc. I
describe this report about quality control, quality assurance, and their role in
industry. After that we have clearly described the Raw Material store, Packaging
Material store, FGS. I made a brief case study on DM water plant which is
described in detail.
The paper also described the future scope of industrial training and visits. I
concluded that the whole training is a source of knowledge and helps to gather
precious experiences.

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 INTRODUCTION
The company started its operation in the year 1945 under the leadership of its
founder, Mr. Gour Gopal Saha. Initially known as the Standard Medical
Research Institute, the company quickly earned its reputation as one of the most
innovative organizations in India. The name was later abridged to Stadmed.
It is a name widely recognized today for its pioneering pharmaceuticals. It was
the first company in India to produce an amino acid - based enzyme and
blockbuster products like Alkasol, Pulmocod, Aminozyme and Entrozyme
(among others) continue to satisfy generations of patients, aiding in their speedy
recovery.
MISSION
STADMED commits itself to satisfy its customers' needs through excellent
service, by developing and marketing an effective, safe, quality product and by
offering our product at an affordable price to all patients.
OPERATION
Our Marketing operations span the States of West Bengal, Odisha, Bihar,
Assam, Tripura, Manipur, Nagaland, Uttar Pradesh, Rajasthan, Haryana, Punjab,
Himachal Pradesh, Tamil Nadu, Andhra Pradesh, and Union Territory of Delhi.
Our Marketing operations also exist in Nepal. The plans for expansion, to attain
critical mass to face the challenge of the 21st century, are already in place for
STADMED.
VISION
Our vision is to become one of the indisputable leaders in the pharmaceutical
industry which would primarily be intended to enhance quality of human life.
To develop a highly motivated & empowered team of professionals and their
continuous development. To see STADMED as an Institution for ethical &
respectable world class pharmaceutical company.

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 OINTMENT - SEMI SOLID DOSAGE FORM
 Ointments are semi solid preparation meant for external application to the
skin or mucous membrane.
 Drug ingredients can be dissolved, emulsified, or suspended in the
ointment base.
 TYPES: Unmedicated Ointments (Petroleum jelly) & Medicated
Ointments (Dermatologic ointments, Opthalmic ointments, Rectal
ointments etc.)

GENERAL METHOD OF PREPARATION

 The oil phase is taken in an ointment/cream preparing homogenizer. The
temperature is maintained at 60 to 70 degrees Celsius.
 Ointment base added that is white liquid paraffin.
 After that water phase is added to Preservatives like methylparaben,
propylparaben, etc. Temperature should be between 60 to 65 degrees
Celsius. After that the temperature decreased to S0 to 54 degrees Celsius.
 Then the active ingredients are added. The temperature decreased to 27
degrees Celsius.
 Then the ingredients should be mixed properly in the Homogenizer and a
mass mixture of ointment is formed. After that It is transferred into a
vessel and kept for cooling for several hours. Then it is transferred into
Tube filling machine, required size ointment tubes placed after that tube
gets filled and sealed, then goes for packaging. And finally, to the market.

HOMOGENIZER MACHINE

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OINTMENT TUBE FILLING AND SEALING

Put empty Sensor

Dust Filling
tube in Detect Black
Aspirator
Hopper Mark

Batch no Second
First fold Tap
print fold

Ejection

OINTMENT TUBE
FILLING MACHINE

PACKAGING
The tube was the primary packaging for the ointments. After that the secondary
packaging is done. A cartooning machine picks a single piece from stack of
folded carton and erects it, fills with a product or bag of products or number of
products horizontally through an open end and closes by tucking and end flaps
of the carton or applying glue or adhesive. The product might be pushed in the
carton either through the mechanical sleeve or by pressurized air. This type of
cartooning machine is widely used for packaging medicine (external
preparation) Cosmetics, etc.
SOME IMPORTANT OINTMENT PREPARATION BY STADMED LTD.
Sucral Ano, Sucral Povi, Mupon, Sucral MU.

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 TABLET- SOLUD DOSAGE FORM

PROCEDURE FOR TABLET MANUFACTURING

 Dispensing: Each ingredient in the tablet formula is weighed and
accurately dispensed as per dose. This is one of the critical steps in any
type of formulation process and should be done under technical
supervision.
 Sizing: Formulation ingredients must be in finely divided form,
otherwise, size reduction should be carried out for better flow property
and easy mixing.
 Powder Blending: Powders are mixed using a suitable blender to obtain a
uniform and homogenous powder mix. The drug substance and excipients
are mixed in geometric dilution.
 Granulation: Here small powder particles are gathered together into
layers, and permanent aggregates to render them into free-flowing states.
 Drying & Dry Screening: Screened wet granules need to be dried fora
particular time period in tray dryer or fluid bed dryer at controlled
temperature not exceeding 550 degree C. Dried granules are screened
through the appropriate mesh screen.
 Tablet Compression: This step involves the compression of granules into
a flat or convex, round, oblong, or unique shaped, scored and unscored
tablets; engraved with an identifying symbol and or code number using
tablet press.
 Coating: Tablets and granules are coated if there is need to mask the
unpleasant taste/Oduor of some drug substance or to increase the
aesthetic appeal of uncoated tablets as well as to modify the release of
drug substance from tablets. This is achieved by enclosing or covering the
core tablet or granules with coating solutions.

Methods used in tablet Formulation:

Tablets are commonly manufactured by
 Wet granulation
 Dry granulation
 Direct compression

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 STEPS FOR TABLET PRODUCTION:

Equipment Used In Granulation Area:

 Weighing Machine
 Sifter
 Multi mill
 Planetary Mixture
 Rapid Mixing Granulator
 Fluidized Bed Dryer
 Octagonal Blender
 V- cone Blender
 Paste Kettle

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TABLET COMPRESSION:
A tablet press is a mechanical device that compresses powdered into tablets of
uniform size and weight. A tablet press can be used to manufacture tablets of a
wide variety of materials, including pharmaceuticals, nutraceuticals, cleaning
products, industrial pellets and cosmetics.
Tablet compression machine, or tablet press are designed with the following
basic components:
 Hoopers for holding and feeding granulation to be compressed.
 Dies that define the size and shape of the tablet.
 Punches for compressing the granulation within the dies.
 Cam tracks for guiding the movement of the punches.
 A feeding mechanism for moving granulation from the hooper into the
dies.
In Stadmed Pvt. Ltd. There were double rotary 27 station tablet compression
machine (D-type), 27 station tablet compression machine(B-type) and 35 station
tablet compression machines(B type).
 Filling of granules from hopper
 Excess lowering of lower punch
 Weight adjustment via weight adjustment knob
 Lowering of upper punch
 Pre compression
 Relaxation
 Compression
 Lower punch moves down
 Upper punch moves up
 Ejection of tablet and they get scrap via scrapper
 Same step as that of 1
TABLET COATING:
Tablet coating is the process where coating material is applied to the surface of
the tablet to achieve the desired properties of dosage form over the uncoated
variety. The advantages of coating are listed below,
 Improving taste, odour, and color of the drug
 Improving ease of swallowing by the patient
 Improving product stability
 To protect against the gastric environment

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  To improve the mechanical resistance of the dosage form
Equipment: There are two types of coating pans:
1. Perforated coating pan (e.g.: Acela Coating)
2. Non-Perforated Coating pan (e.g.: Pellegrini Coating)
Coating Machine: Unicota-36 is used for coating
MATERIALS
o Non-Enteric Materials- HPMC, Methyl Hydroxy Ethyl Cellulose,
Hydroxy Propyl Cellulose, Povidone, Polyethylene Glycols Acrylate
Polymers (Eudragit), Ethyl cellulose (30% solution in ethanol known as
aqua coat), Sodium CMC.
o Enteric Materials- Cellulose Acetate Phthalate, Acrylate Polymers, Poly
Vinyl Acetate Phthalate.

IPQC (ln Process Quality Control) TESTS FOR TABLETS:

 Hardness test
 Friability Test
 Thickness Test
 Disintegration Test
 Weight Variation
 Content Uniformity
 Dissolution

PACKAGING:
Primary Packaging of Tablets- Blister packs are a common form of packaging.
They are safe and easy to use, and the user can see the contents without opening
the pack. The expiry date and the drug name must be printed on each part of the
package. The blister pack itself must remain absolutely flat as it travels through
the packaging process, especially when it is inserted into a cartoon. Extra are
added to blister pack to improve its stiffness.
Materials Used:
1. PVC- The most basic material for the forming web is polyvinyl chloride
(PVC)

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 2. PVDC- Polyvinylidene chloride (PVDC) can be coated ontoa PVC film.
PVDC coated blister films are prevailing barrier films used for
pharmaceutical blister packs.
3. LIDDING FOILS- Pharmaceutical blister packs are mostly closed by
push-through or peel open lidding foil. The lidding foil is coated with a
heat seal lacquer on the inside and a print primer on the outside.

Secondary & Tertiary Packaging

o Ply Used- 3ply/Sply/7ply
o Tep Used- BOPP Tep.

SOME IMPORTANT TABLETS PREPARED BY STADMED

PHARMACEUTICALS:
 EMFOR S00 SR
 IHD 20
 TELMISTAD 20
 GLIZA MF
 METFORMIN HYDROCHLORIDE PROLONGD RELEASE TABLET
 ZOLAM
SOME IMPORTANT TABLETS PREPARED BY STADMED
PHARMACEUTICALS:
 EMFOR S00 SR
 IHD 20
 TELMISTAD 20
 GLIZA MF
 METFORMIN HYDROCHLORIDE PROLONGD RELEASE TABLET
 ZOLAM
ORAL D0SAGE FORM-LIQUID

Liquid dosage forms are one pf the ancient dosage form. It has the most
important advantage, that it is very easy to administrate. For the manufacturing
of liquid dosage forms following procedure may be adopted- mixing APl and
excipients, fitration, storage, filing, sealing, packing and finished product store.

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EQUIPMENT USED IN MANUFACTURING UNIT:
1. HOMOGENIZER- It is one of the machines which is mainly used for proper
mixing of the drug with preservative as mentioned in the IP.
2. FILTER- It is mainly used for proper fitration of the drug.
3. STORAGE- Vat used to store prepared liquid.

LIDUID FILLING AND PACKING

UNIT

Bottle
Shifting Reach in Washing
fill in
through wash in by Belt
turn
Belt machine
table area

Reach in Liquid
Cap. Belt Liquid fil
capping filling
sealed in proper
&sealing machine
amount
area

Checkin Goes
Reach Labell for
g ORAL
labell in ed final
Belt D0SAGE
gmachi details AND
FORM-
LIQUID packa
area for ging
defects

SOME IMPORTANT LIQUID PREPARATION:

SYRUP- Alkasol, Lenazine, Locof, Pulmirest LF, Pulmorest D Suspension,
Digilox MPS
SUGAR SYRUP- Sugar with multivitamin syrup Pulmocod CG, Pulmocod
Plain
Pruducts Manufactured During Our Visit:
ALKASOL
Chemical Name- Disodium Hydrogen Citrate BP
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Therapeutic Action
 Urinary Tract Infection,
 Burning micturition,
 Kidney stone.
QUALITY CONTROL DEPERTMENT

Quality control is an essential operation of the pharmaceutical industry.

Drugs must be marketed as safe and therapeutically active formulations
whose performance is consistent and predictable. New and better
medicinal agents are being produced at an accelerated rate. At the time
at the same time more exacting and sophisticated analytical methods are
being developed for their evaluation. "A part of quality management
focused on fulfilling quality requirements". This approach places
emphasis on three aspects (enshrined in standards such as IS0 9001):

1. Limits such as controls, job management, defined and well managed

process. Performance and integrity criteria and identification of records.
2. Competency, such as knowledge, skills, experience and
qualifications.
3. Soft elements, such as personnel, integrity, confidence,
organizational culture, motivation, team spirit and quality relationships.
TABLET DISINTEGRATION TEST:
The disintegration test is used to show how quickly tablet breaks down into
smaller particles, allowing for a greater surface area and availability of the drug
when taken by a patient. Disintegration tests are however, useful for assessing
the potential importance of formulation and process variables on the
biopharmaceutical properties of the tablet, and as a control procedure to
evaluate the quality reproducibility. To carry out a disintegration test for tablets ,
we use a basket which holds one to six tablets. This ls then raised and lowered
into a beaker of water, which is used to stimulate conditions in the stomach at
37-degree C. If the tablets or capsules float, pertorated plastic discs are placed
on the top of the tablets to keep them under the water level. The tablet
disintegratlon time is taken when no residue is left in the mesh.
Disintegration testing can be affected by various factors which include :
 Binders
 Lubricants
 Surfactants
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  Hardnes

TABLET DISSOLUTION TEST:

Dissolution testing is an important tool for characterizing the performance of
oral solid dosage forms. Its significance is based on the fact that for a drug to be
effective, it must first be released from the product and dissolve in the
gastrointestinal fluids before absorption into the bloodstream can happen. In
other words, the rate and extent of drug absorption are determined by its
dissolution form the dosage form.
THE PURPOSE OF DISSOLUTION TESTING:
For a commercial product, this test is routinely used for quality control and
quality assurance purposes, to ensure consistency between production batches,
or to justify scale up and post approval changes made to the manufacturing
process. in early phase drug development, dissolutiorn testing aids formulation
design and drug delivery optimization; it is primarily carried out to assess
product stability, monitor formulation changes overtime, and stablish in vitro in
vivo correlation. In case where in vitro in - vivo correlations have been
demonstrated, dissolution can be used as a surrogate test to predict the in vivo
performance of drug products. From a regulatory perspective, dissolution
testing plays a major role in the decision-making process, particularly in the
development and approval of genetic process forms where unnecessary human
studies can be avoided without compromising the quality of the generic.
FACTORS AFFECTING DISSOLUTION:
A dissolution test measures the amount of drug that goes into solution over a
period of time under standardized conditions. Factors that affect the dissolution
of a drug product includes the intrinsic properties of the API (e.g., Solubility,
wettability, particle size, surface area, morphology, polymorphs), the
formulation composition and characteristics (e.g., experience, hardness,
manufaçturing processes) and the dissolution method used for its assessment
(e.g. apparatus medium, test conditkons, sampling and sample analysis).
METHOD DEVELOPMENT:
In dissolution testing the aim is to develop a discriminatory method that is
sensitive to variables that affect the dissolution rate, and consequently, the in
vivo performance of the drug product. The method must be able to distinguish

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between drug products manufactured under target conditions and formulations
with meaningful variations for the most relevant critical manufacturing
variables, such as drug substance particle size, compression force and the tablet
hardness. The dissolution method should also be sufficiently rugged and
reproducible for daily operations as well as transferable between laboratories.

UV-VISIBLE SPECTROMETRY

UV visible spectroscopy is an analytical technique that measures the number of

discrete wavelengths of UV or visible light that are absorbed by or transmitted
through a sample in comparison to a reference or blank sample. This property is
influenced by the sample composition, potentially providing information on
what is in the sample and at what concentration. Since this spectroscopy
technique relies on the use of light, let's first consider the properties of light.
light has a certain amount of energy which is inversely proportional to its
wavelength. Thus, shorter wavelengths of light carry more energy and longer
wavelengths of light carry less energy. A specific amount of energy is needed to
promote electrons in a substance to a higher energy state which we can detect as
absorption. electrons in different bonding environments in a substance require a
different specific amount of energy to promote the electrons to a higher energy
state. This is why the absorption of light occurs for different wavelengths in
different substances. Humans are able to see a spectrum of visible light from
approximately 380 nm, which we see as Violet, to 780 nm which we see as red.
UV light has wavelength shorter than that of visible light to approximately 100
nm. Therefore, light can be described by its wavelength, which can be useful in
UV visible spectroscopy to analyze or identify different substances locating the
specific wavelengths corresponding to maximum absorbance.

HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

High-performance liquid chromatography (HPLC) is an important analytical
method commonly used to separate and quantify components of liquid samples.
In this technique, a solution (first phase) is pumped througha column that
contains a packing of small porous particles with a second phase bound to the
surface. The different solubilities of the sample components in the two phases
cause the components to move through the column with different average
velocities, thus creating a separation of these components. The pumped solution

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is called the mobille phase, while the phase in the column is called the
stationary phase.

HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

Before beginning an HPLC experiment, we must recognize the various

components essential to perform the process.
HPLC Pump: The HPLC pump produces high pressure that gives a continuous
and reproducible flow to the mobile phase throughout the HPLC system. E.g.,
Reciprocating pump, syringe pump, and pneumatic pump.
HPLC Mobile Phase: It is a solvent or contains a combination of water with
organic solvents, an ideal amount of an aqueous solution with polar solvents, or
mixtures of organic solvent. HPLC Degasser: It is a tool for removing gas from
a mobile phase used in HPLC.
HPLC Injector: A sample injector is a device used to inject samples solution
into the HPLC system. Eg., Rheodyne injector, septum injector, and stop flow
injector.
HPLC Column: The column is the key component of HPLC as it is responsible
for separating the analytes of the sample mixture. Columns are now designed
for use at high pressure in stainless steel tubes. Typically, silica gel is filled into
the HPLC column known as the stationary phase.
HPLC Oven: It is a device used to control the temperature of a column.

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HPLC Detector: A detector is a device used to detect compounds separated
from a column. The detector transforms the effluent into an electrical signal and
is recorded by the computerized systern. E.g., UV/VI'S detector, PDA detector,
Mass detector (LCMS), Fluorescence detector, and Infrared detector, etc.

ADVANTAGES:
High-performance liquid chromatography provides a simple, automated, and
highly accurate method of ldentifying certain chemical components in a sample.
The HPLC provides a quantitative and qualitative analysis that is simple and
accurate. It can be upgrading to mass spectroscopy.
PH METER:
PH meter is an instrument used to measure acidity or alkalinity of a solution
also known as pH. PH is the unit of measure that describes the degree of acidity
or alkalinity. It is measured on a Scale ofoto 14. Compared to other
chromatographic techniques such as column chromatography, TLC, and paper
chromatography, HPLC is fast, effective, and delivers high resolution,. The
gradient elution is readily adaptable in HPLC. The quantitative information
provided by the pH value expresses the degree of the activity of an acid or base
in terms of hydrogen ion activity. The pH value of a substance is directly related
to the ratio of the hydrogen ion and the hydroxyl ion concentrations. If the H+
concentration is greater than OH-, the material is acidic; I.e.; The pH value is
less than 7. If the OH- concentration is greater than H+, the material is basic,
with a pH value greater than 7. If equal amounts of H+ and OH- lons are present
the material is neutral, with a pH of 7. Acids and bases have free hydrogen and
hydroxyl ions, respectively. The relationship between hydrogen ions and
hydroxide ions in a given solution is constant for a given set of conditions,
either one can be determined by knowing the other.
KARL FISCHER TITRATOR: Karl Fischer titration is a classic titration
method in chemical analysis that uses coulometric or volumetric titration to
determine trace amounts of water in a sample. It was invented in 1935 by the
German chemist KARL FISCHER.
OTHER INSTRUMENTS:
 Meiting point apparatus "
 Elga water purifier Picnometer
 Bursting test apparatus .
 Automatic titrator
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  Conductivity meter
 Polarimeter
 Hot plate Magnetic stirrer

MICROBIOLOGY DEPERTMENT
Microbiology is defined as the branch of microbiology dealing with the
structure, function, uses and modes of existence of microscopic organisms.
MICROBIOLOGY TEST METHODS
STERILITY TESTING- We have a state of the heart, purpose-built sterility test
isolator incorporating a vaporized hydrogen peroxide generator, minimizing the
potential of false positives associated with other types of sterility testing
environments.
We use two methods to perform sterility testing:
 Membrane Filtration
 Direct Inoculation

ANTIMICROBIAL EFFICACY TESTING (AET)- At Lucideon, we can

perform antimicrobial effectiveness testing (AET or PET) to Ph. Eur. and USP
on an array of products. The product is inoculated with a specified number of
each challenge Organism. Over a period of 28 days the product is examined to
determine the number of viable microorganisms which survive at each time
interval.
MICROBIAL LIMIT TESTING- For non-sterile products, we can perform
microbial contamination testing using harmonized pharmacological or clients
applied methods to determine the bioburden within the sample. Microbial
enumeration- Total Yeast and Mould Count (TYMC) and Total Aeroabic
Microbial Count (TAMC) analysis and tests for specified microorganisms are
employed for this.
BÊOBURDEN DETERMINTION- Bioburden testing is performed by lucid
and to ensure that your products comply with the associated standards.
Lucideon offers assessment of the quality of your production processes and can
work with clients to produce solutions and improvements.
Bioburden testing is used in a number of situations as part of:
 Validation and revalidation of sterilization processes

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  Routine monitoring for control of manufacturing processes
 Assessment of the efficiency of cleaning processes

ENDOTOXIN (LAL) TESTING- We And perform anabysis of endotoris using

kinetic Turbidimetric methodology. imulus Armoebocyte Lyate (UAL) is used
to detect and quantty bacterial endotoxins extracted from the products.
ENVIRONMENTAL MONITORING AND IDENTIFICATION- Our
experts can incubate, enumerate and identify flora from your environmental
monítoring processes. Using system to complement traditional gram stain and
microscopy techniques we are able to identíty a vast library of environmental
and dinical organisms to aid in background ervironmental analysis, failure
investigations and contamination issues.
WATER ANALYSIS- Whether it's analyzing water quality of pharmacological
monographs (Ph. Eur., USP, BP, JP), HTM derivatives, Microbiology of
drinking water or Total Organic Carbon (TOg -At Lucideon we can help.
DIFFERENT EQUIPMENTS :
 Autoclave
 Hot Air Sterilization
 Incubator Colony Counter
 Dynamic Pass Box

STORAGE AREA

DIFFERENT STORAGE CONDITIONS IN PHARMACEUTICALS:

According to the pharmaceutical drug material different storage conditions are
required to maintain their quality. Some Chemicals and solutions in quality
control and media in microbiology section are required to store in specific
conditions.
STORAGE CONDITION LIMIT
ROOM TEMPERATUR 20 to 25 degrees
COOL STORAGE CONDITION 8 to 15 degrees
OLD STORAGE CONDITION 2 to 8 degrees
FRIDGE STORAGE CONDITION 4 to 2 degrees

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Most of the pharmaceutical activities are done at room temperature (20-25
degree C) in pharmaceuticals example: Excipients and APls in warehouse and
all controlled sample are stored room tenmperature. Which drug substances
degraded at room temperature those are stored in cool storage condition (8 to 15
degree C). Cold storage condition decreases the rate of chemical reaction and
microbial growth. Highly degradable drug vitamins and chemicals are stored at
cold storage condition (2 to 8 degree C). Reference standards, HPLC and GC
standards, vitamin standard solution, limit test standards in quality control are
stored at cold temperature condition. Some culture media are also required to
store at this temperature. It helps to maintain them for a long period by slowing
down their vegetative growth. Culture suspension prepared in normal saline
retains living microorganism for one week if stored at cold temperature storage
condition. Packaging in the Pharmaceutical industry varies from drug to drug
and normally there are three levels of packaging commonly referred to as the
primary, secondary, and tertiary packaging .
Primary Packaging System- is the material that first envelops the product and
holds it, i.e.; boost package components and subcomponents that actually come
in contact with the product, or those that may have a direct effect on the product
shelf-life e.g., ampules and vials prefilled syringes IV containers, blister packs,
etc.
Secondary Packaging System- is outside the primary packaging and used to
group primary packages together e.g., cartons, boxes, shipping containers,
injection trays, etc.
Tertiary Packaging- is used for bulk handling and shipping e.g., barrel,
containers, edge.
TYPES OF PHARMACEUTICAL PACKAGING:
 Containers
 Aluminium foil Injectables/Vials Bottles
 Cartons
 Paper Board
 Lamitubes
 Paper
 PVC Based Combinations
TEST FOR PACKAGING MATERIAL:
 Grain Direction Test- It is a type of test of packaging material.
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  Lacquer Porosity Test- Done for aluminium foil as a QC test.
RAW MATERIAL STORE
 Purchases of Raw Material
 Table Of Contents Purchase of Raw Material
 Receiving, Handing and Storage of Raw Material Sampling
 Testing of Samples Approval/Rejection of Raw Materials Labeling
 Using Approved Raw Material
 Handling Rejected Raw Material
 Containers and Closure
Purchasing must be done by staff with a thorough knowledge of suppliers.
Materials must be those materials and their procured only from approved
suppliers who have consented provide materials in to keeping with the quality
Pharmaceutical manufacturers should enter specifications of the drug product
manufacturer. into contracts with specific vendors after performing a and
vendor meeting audit quality that assures raw materials and packaging materials
of the desired level of safety standards.
RECEIVING, HANDLING, AND STORAGE OF RAW
MATERIAL:
Specific written procedures must be prepared to describe how materials (both
drug and drug containers and components closures) will be and accordingly
received, identified, stored, handled, sampled, tested, approved or rejected, and
these procedures must be receiving raw materials, followed as written. When
the consignment must be visually examined and the confirm labels checked to
the content, quantity, integrity of seals and to verify that there is no damage or
contamination. Any damaged containers found must be separated, and details
recorded and informed to the drawn and supplier. The materials must be stored
under quarantine until samples have been and storage tests of all have raw been
materials performed. They must not be issued for use before approval. Handling
in the storage area must be done in such a way that there is no contamination.
Boxes or bags holding containers and closures must be stored off the floor. The
storage must be done in a way that suitable space is left for proper cleaning and
inspection of the materials.
SAMPLING:
Representative samples must be drawn from each shipment of each lot. If
different batches are present in a single shipment, samples must be drawn from
each of those. The quantity must be sufficient to perform all required tests and

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reserve when specified. Statistical criteria must also be used to determine the
number of samples drawn. Containers must be cleaned before sampling to avoid
contamination and resealed after sampling to prevent contamination of the
contents and appropriately labelled to show sample has been taken.
TESTING OF SAMPLES:
At least one specific test must be performed to verify the materials identity.
Tests must be carried out to determine conformity with predetermined
specifications for quality, strength, and purity. In is materials are supplied along
with a certificate of analysis by the supplier, the materials maybe used without
sampling and testing, provided the supplier is a reliable, validated vendor and at
least one specific identity test has been performed and mentioned in the
certificate. Materials that are lable to contamination with adulterants, or insect
infestations, or filths must be examined for such contaminants. If materials are
prone to microbial contamination, microbiological tests must be performed to
test for them. Approval/Rejection of raw material: All materials that meet the
manufacturers quality requirements of identity, quality, purity, strength and
other tests are to be approved for use. Materials not meeting these requirements
must be rejected.
LABELLING:
Labels Must carry the name of the product, the company's unique reference
code, manufacturers name and address, and their assigned batch number. It must
also state the status of the contents (For example- Sampled, Quarantined,
Approved, and Rejected), Manufacturing and expiry dates and re-test date.
When attaching such labels, care must be taken that original information on the
supplier's level is not last. Approved Materials must be so marked while rejected
materials must be conspicuously labeled and stored ina separate area to avoid
chances of mix-ups or misuse.
USING APPROVED RAW MATERIAL:
Approved Material must be stored properly and issued for use in a way such
that the earliest approved stock is used first before more recently approved
stock. Many companies use a FEFO (First Expire First Out) System for stock
rotation. Another deciding factor is that the drug products self-life must not
exceed the shelf life of the APls. If materials have been stored for a very long
period without usage, or if they have been exposed to any condition that may
harm their quality or safety, they must be retested for the same parameters as the
initial test. Results Off the retest must be used to determine if the materlals are
approved or rejected.
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HANDLING REJECTED RAW MATERIAL:
Rejected Mterials must be identified with appropriate levels and kept in
quarantine until safely disposed. Care must be taken to prevent the use of such
materials in manufacturing operations.
CONTAINERS AND CLOSURES:
Containers And closures are used for the packaging of drug products must not
be reactive or absorptive. This additve it's important to ensure they do not cause
a change in the safety, quality, strength, or purity identity, of the drugs beyond
must specifications. Closures and containers be capable of protecting the drug
product from external contamination or conditions that may cause its
deterioration, Containers and closures must be clean and if required sterilized to
remove contamination by microorganisms and pyrogens.

MIX DM-PLANT / PURIFIED WNATER PLANT

DM Water System produces mineral free water by operating on the principles of

ion Degasification, and polishing. Demineralized Water exchange, System finds
wide application steam, power, process and in the field of cooling. In the
context of water purification, ion and reversible process in which exchange is a
rapid impurity ions present in the water are replaced by ions released by an ion
exchange resin. The impurity ions are taken up by the resin, which must be
periodically regenerated to restore it to electric charge. Positively the original
ionic form. An ion is an atom or group of atoms with an charged ions are called
cations and are usually metals; negatively charged ions are called anions and are
usually nonmetals.
TEO BED DEIONIZATION:
In cases where higher quantities of water are configured. In the two - bed
needed, two for bed di water system may be configuration, the resins are
separated based on the they attract. type of minerals from The first this tank is
filled virtualy with absent cation resin, of a negatively charged hydrogen ions
(H+). Water produced very low acidic pH every positively charged ion except
for hydrogen, and has a level (2-2.5). The second tank is filled with anion resin,
a positively charged resin bed used to attract the negatively charged hydroxyl
ions (OH-). Water produced from this negatively tank is virtually absent of
every charged ion except for hydroxyl, and has a very high pH level (9-9.5).

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MIXED BED DEIONIZATION:
Mix bed deionizer all mixed bed polisher is typicaly installed where water
quality is less micro-Ohm than one conductivity is required. Mix Bed Deionizer
is a single shell unit and contain with strongly acid cation and strongly basic
anion with proper ratio. A mix bed ion exchanger in water purification uses to
iron exchange regenerate if systems formed in beds shape. It allows OX turn
and announce resin beds two mix together to remove impurities to produce high
quality water.
D.M WATER PLANT:

USE:
DM Water used to prepare the entire pharmaceutical product in industry. Water
is demineralized to prevent contamination during the preparation of
pharmaceutical dosage forms.
FORMULATION & DEVELOPMENT (F&D):
F&D department is the very important department of the pharmaceutical
industries. Before the big batch manufacturing, small batch of drugs are
manufacturing in F&D department and maintain the quality control like as pH,
solubility, disintegration, moisture content, hardness of tablet. friability etc. If it
processes the taste under 0C department then big manufacturing batch will be
start. Accelerated and long-term stability studies are done in F&D Department .
QUALITY ASSURANCE DEPARTMENT (QA):
The purpose of pharmaceutical quality assurance is to ensure that the
medication being manufactured will provide the desired effect to the patient.

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Quality assurance also guarantees that there are no contaminants present and
that the medications will meet quality requirements and all relevant regulations.
Quality assurance Department shell function for assuring the quality of all the
products manufactured at every stage of manufacturing/ processing of drug
products This Shelby achieved by performing the functions of monitoring as per
the lead systems for the following areas which is not limited to this.
Quality Assurance Department Functions are Listed Below:
1. Ensuring proper warehousing practices: For incoming components (APIS)
APIS, Excipients, Packaging Materials, Containers and Closures, Labels with
proper storage conditions which is required for drug stability, etc.
QA department is responsible for the proper storage of API and other excipients
and segregation of the material in the warehouse.
2. Manufacturing process and critical process checks: This he's one of the most
critical activities performed by the QA department.
• For this activity special team is assigned named as IPQA (In Process Quality
Assurance). Which keep an eye on all floor activities related to the storage of
RM to the final product dispatch.
• Before starting in the manufacturing process, the IPQ a person ensures the
paperwork and physical condition of the area.
• Where the product is going manufactured during the manufacturing of the
product several sample or collected by IPQA for testing to ensure the quality of
the product during the manufacturing process.
3. Process monitoring and process controls: During the manufacturing of the
product the whole process is monitored by the QA department and
• Ensure that all the steps followed for the manufacturing of the product are
validated and as per SOP. If the QA person is found any alteration in the method
of manufacturing of the product, then the appropriate action is taken to ensure
the quality of product.
4. All The data which is generated during the manufacturing of the
pharmaceutical product is recorded in a file (soft copy/Hard copy). Which Heals
us about the all-essential data related to product manufacturing (e.g.- Timing
Off process, ingredients, environmental conditions, person involved etc.), in the
end of the manufacturing process.

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5. QA person Review the battery cord to ensure the data entered in the batch
record is legible if QA person found any kind of data integrity issues, then the
appropriate action is taken as per the SOP.
6. Final Release of drug products for distribution and sale: When the
pharmaceutical product is manufactured and packed then the role of QA comes
to ensure that the product is safe for market or not, All the test reports are
attached with the batch record All the calculation related to that batch are
correct and several other letters are checked after ensuring the product Salery
then the QA person allowed to distribute in the product.

DOCUMENTATION

FORMULA MASTER RECORD (MFR):

License Should maintain records relating to all manufacturing procedures for
each product and batch size to be manufactured. It also includes patent or
properly status; name of formulation along with generic name if any; quantity
and reference number of starting material; strength; dosage form; description;
identification; composition; statement for processing instruction; in process
control; requirements for stage conditions; packaging details etc.
BATCH PROCESSING RECORDS (BPR):
BPR For each product; clean equipment; name of product; number and batch
being manufactured; dates and time of operation; significant intermediate
stages; initials of operator of different steps of production; batch number;
analytical control number; in process control records; amount of product
obtained; note on any deviation from master formula; addition of any recovered
or reprocessed material.
STANDARD OPERATING PROCEDURES (SOPS) & RECORDS:
SOP and Records for receipts of each delivery of row, primary and printed
packaging material; sampling; instrument and equipment; internal labeling;
maintenance; cleaning and sanitation; personnel; paste control; complaints and
recalls made and returns received.

ABBREVIATION

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  GMP = Good Manufacturing Practice, HPMC: Hydroxy Propyl Methyl
Cellulose, HPC: Hydroxy Propyl Cellulose
 PEG = Polyethylene Glycol
 SCMC = Sodium Carboxyl Methyl Cellulose
 IPA = Iso Propyl Alcohol
 R.M = Raw Material
 P.M = Packaging Material
 FGS = Finished Good Storage
 IPQC = In process Quality Control

CONCLUSION

The industrial traning was successtul. I want to thank all the departments of he
industry tiont the bottom oe my heart for giving me their valuable time, support
and technical as well as industrial pharmaceutical education like quality control,
quality assuranee, manutàcturing and packaging of different pharmaceutical
products. From this study, I learnt a lot and have gained a lot of hands-on
experience. This training redefines my experiences which I had gone through
my pharmacy course curiculum. I find a relation between theoretical and
practical pharmacy. I also want to thank the respective teachers who gave their
valuable tine on explaining how the thing actually goes on in their respective
fields. I have leamt various pharmaceutical terminologies, thanks to this
training. Lastly, I would like to say, it was a great experience for me and it will
surely help me in future and help me grow through my practical knowledge.

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