this is industrial training report of 45 days from pharmaceutical manufacturing industry for a pharmacy student

1. Industrial Training
Report
Submitted in partial fulfillment of the requirement for the degree of Bachelor of
Pharmacy, CT Institute of Pharmaceutical Sciences.
Submitted By – Pawan
B.Pharmacy 7th
Sem
Roll No. - 1438306
CT Institute of
Pharmaceutical Sciences

2. CERTIFICATE
This is to certify that Mr. Pawan, a student of Department of Pharmaceutical Sciences, CT
Institute has completed the compulsory Industrial Training (four week) in the concern Pharma
limited, Ludhiana (Sahnewal) in India during summer vacations after 3rd
year of four year
integrated B.Pharm degree course.
Place; Jalandhar (Asst. Prof. Narinder singh)
Date…………... Deptt. Of Pharmaceutical sciences
CT Institute of Pharmaceutical Sciences
Jalandhar – 144020 (Punjab)

3. ACKNOWLEDGEMENT
I consider it a great privilege and honor to have the opportunity to undergo the industrial
training work in Concern Pharma Limited. Hence, I would like to offer my heartiest thanks to
Mr. Sumit (Chemist) and Mr. Arvind Sharma.
I am greatly indebted to Assit. Prof. Narinder Singh, Department of Pharmaceutical Sciences,
for enabling us to have the chance of industrial training and arranging such a nice arrangement.
I am greatly thankful to all my seniors and colleagues in OPL for extending their constant
cooperation which went a long way towards the completion of this Training and Report.
Pawan
Department of Pharmaceutical Sciences
CT Institute of Pharmaceutical Sciences
Jalandhar – 144020 (Punjab)

4. PREFACE
Pharmacy is a profession which is concerned with the art and sciences of preparing suitable
and convenient material for distribution and use in the treatment and prevention of disease, so it
is fully technical profession where practical knowledge is much more important along with
theoretical knowledge.
According to curriculum of a four year integrated degree course of Bachelor of Pharmacy each
student has to undergo practical training for a period of four week in a various pharmaceutical
industry in India. As it is to be done during summer vacation after 3rd
year of B.Pharm.
I was directed to undergo 4 week training at “Consern Pharma” and this report contains a
brief description of the above pharmaceutical industry which was observed during the training
program.
Pawan
Department of Pharmaceutical Sciences
CT Institute of Pharmaceutical Sciences
Jalandhar – 144020 (Punjab)

5. INTRODUCTION
Consern Pharma Private Limited started its business operations in 1996 and formally
incorporated as a company in 2001, has successfully carved a niche for itself in the drug
formulation sector & established itself as a reputed name in Pharmaceutical Industry with the
purpose of serving humanity, the Company’s formulations strictly confirms to international
standards at very affordable & competitive price.
Backed by a team of professionals and empowered by newest technology & state-of-the-art
manufacturing unit, Company has attained manufacturing competence by adhering WHO-GMP
Certification accredited by the Joint Accreditation System of Australia & New Zealand
(JAS-ANZ).
Company has established a Countrywide Sales & Marketing network in India through a
professionally trained Sales-force & highly motivated network of Business Associates to make
our products available at all places and at all times. our product range are CNS Stimulants, Anti
Migraine, Sedative Hypnotics, Cognitive Enhancers, Anti Depressants, Anti Anxiety, Anti
Psychotics, De - Addiction Medicines, Other Formulations, Modafinil Tablets - Modnite,
Zaleplon Capsules - Hyplon, SNRI Anti - Depressants, Aripiprazole Tablets, Quetiapine
Tablets, Mecobalamin Tablets, Anti - Pakinsonism, Cognitive Enhancers etc.
Our Vision - “To be one of the reputed pharmaceutical process-driven companies across the
globe for providing quality products at competitive prices through innovative and customer
focused services.”
Our Mission - “The mission of Consern Pharma is to create healthy lives & peaceful minds by
producing quality Products through advanced technology, excellent teamwork and sound
business practices while focusing on individual growth within the organization.”
Our core values - We at Concern, focus on the following fundamental values to be held by all
within the organization:
 Performance focus
 Passion for excellence
 Transparency
 Family like work culture
 Stress free working environment
 Participative decision making
 Concern for society & environment
 Profit is not a prime concern

6. Our team - Our people are our Greatest Asset…and the reason for our growth and success.
The Company is aided with the best team of professionals all having expertise in the respective
field. The upgraded technology helps them further in executing their work without any
hindrance. The company has very less manpower turnover and it is growing like a family. There
are 80 dedicated people from various disciplines. The team undergoes strenuous in-house &
external training programs to make them familiar with the company's work procedures and to
enhance their knowledge & skills (in particular WHO-GMP/ISO introduction & reinforcement).
Our Certificate - Consern Pharma Pvt. Ltd. is a WHO-GMP Certified. The Quality
Management System (QMS) is customer focused & aimed at enhancing customer satisfaction. It
also meets the regulatory & legal requirements of the product.
Our product range - Consern Pharma Private Limited is a name in the Indian Pharmaceutical
industry which offers a vast range of Neuro-Psychiatry Products such as anti-depressants, anti-
anxiety, sedative hypnotics, mood stabilizers, anti-convulsants, anti-psychotics, anti-addiction,
cognitive enhancers and anti-parkinsonism medicines.
Apart from neuro-psychiatry drugs, company also offers a range of anti-diabetics, ortho-care,
laxatives, GI care & gynae care products in the form of tablets, capsules, soft gel capsules,
syrups & injections.
Marketing - Concern Pharma has a strong Marketing Network in India backed by a strong
marketing team with ethical approach & customer focus. It is actively involved in the promotion
of its products in all the major Indian states such as Punjab, Haryana, Delhi, J & k, Himachal,
Rajasthan, U.P., Uttarakhand, Bihar, Chattisgarh, Bihar, Jharkhand, Maharashtra M.P., Odisha,
and Chattisgarh & Karnatka. Company is planning to broaden its marketing network in Gujarat,
Andhra Pradesh, Tamil Nadu & north-eastern states of India.
AT present, there are two Marketing Divisions of Concern Pharma.
Cranialz: A division of CONSERN concerned with Mental Health.
Consort: A division of CONSERN concerned with General Health
Our Clientele - "Our success is vested in our Client’s Success" Our Clientage List includes
Doctors from prestigious Institutes, Medical Colleges.
 Doctors from prestigious Institutes
 Medical Colleges
 Mental Hospitals
 Railways & Military Hospitals of India.

7. PRODUCTION SECTION
Tablets component and additives;
A. Active Ingredients; IP, Folic acid, pantoprazole sodium, tranexemic acid,
azithromycin, cefixime, metformin, vitamin B6, glimepride, atorvastatin, voglibose,
bacillus etc.
B. Non active Ingredient; 6 major excipient categories;
1. Diluents; lactose, starch, mannitol,sorbitol
2. Binders; acacia, tragacanth, calcium lactate trihydrate granular N.F., starch
3. Lubricants; stearic acid, magnesium stearate, calcium stearate and talc
4. Disintegrants; starches are the most common disintegrating agents
5. Colors; D&C and FD&C dyes and lakes
6. Flavors and sweeteners; mannitol, lactose, sucrose, saccharin and dextrose
UNIT OPERATION
There are three methods of preparing tablet granulation. These are –
1. Wet granulation
2. Dry granulation
3. Direct compression
Each of these methods has its advantages and disadvantages. The first two steps of milling and
mixing of the ingredients of the formulation are identical, but thereafter the processes differ, each
individual operation of the process is known as a unit operation.
Steps in different methods of tablets manufacturing (Unit operation)
Wet granulation
1. Milling of drugs and excipients
2. Mixing of milled powders
3. Mixing binder solution with powder
mixture to form wet mass
4. Preparation of binder solution
5. Coarse screening of wet mass using
6-12 mesh
6. drying moist granules
7. screening dry granules with
lubricants and disintegrants
8. mixing screened granules with
lubricants and disintegrants
9. tablet compression
Dry granulation
1. Milling of drugs and excipients
2. Mixing of milled powder
3. Compression into large, hard tablets called
slugs
4. Screening of slugs
5. Mixing with lubricants and disintegrating
agents
6. Tablet compression
Direct compression
1. Milling of drugs and excipients
2. Mixing of ingredients
3. Tablet compression
4.

8.  Direct compression method
Drugs adjutants
Compress
Grind Blend Tablet
 Dry granulation process
Drugs Adjuvant
Grind Blend Pellet Crush
Lubricants
Compress
Tablet Blend Screen
1. Wet granulation process;
Drugs Adjuvant Liquids
Grind Blend Agglomeration Pellet

9. Lubricants
Compress Screen
Tablet Blend Dry
EQUIPMENTS
 Sifter; is a device for separating wanted elements from unwanted material or for
characterizing the particle size distribution of a sample, typically using a woven screen
such as a mesh or net or metal. The word "sift" derives from "sieve".
 Planetary mixer; planetary mixer is used for mixing of dry and wet powders, light
pastes, gels, and doughs. This mixer is very popular in the food and bakery industry
because of the simple construction, operation, and relatively lower cost. The planetary
mixer is so named because the mixing blade (commonly known as the beater) rotates in a
planetary motion inside the mixer bowl. The bowl of the single planetary mixer consists
of an upper cylindrical section and a lower hemispherical section. The mixer bowl is
secured to a semi-circular frame (also termed as “fork") at the time of mixing.
 Mass Mixer; Mass Mixer is designed to perform smooth operations for thorough mixing
equipped with safety transparent dust cover & specially designed self-adjusting sealing
arrangement, which ensures the restriction of black particles enter the mixing drum. Mass
Mixer is Ideal for dry & wet uniform mixing of materials. Mass Mixer is available in
sizes ranging from 5 Kgs to 300 Kgs as per GMP & cGMP models.
 Multi mill; can be used widely for wet & dry granulation, pulverization etc. in various
type of applications, such as Pharmaceutical, Cosmetic, Dyes, Colors, Food Products,
Spices, Detergents, Insecticides, Plastics & Resins, Fertilizers etc. This portable, self-
contained unit is useful for high-speed granulation, pulverizing and mixing of a wide
range of wet and dry materials effectively.
 Fluidized bed dryer; Fluidized (fluid) bed dryers are used extensively in the
pharmaceutical industries to reduce moisture content of pharmaceutical powder and
granules. They have also found use in the drying of suspension, slurries, solutions, dilute
paste or sludges. A typical fluidized bed dryer consists of the following components.
 Air preparatory unit.
 Product container.
 Exhaust filter.
 Exhaust blower.
 Control panel.
 Air distribution plate.
 Spray nozzle.

10.  Solution delivers.
 Tray Dryer; this is the device used the drying of the wet products of the crude drugs,
chemicals, powders or the granules etc. In tray dryer hot air is continuously circulated.
Forced convection heating takes place to remove moister from the solids placed in trays.
Simultaneously the moist air is removed partially. The simplest form of the dryer in this
category is a cabinet with a heater at the bottom that is laboratory oven. These ovens are
of very little value because there is no control of the heat transfer or humidity.
 Compression; after the preparation of granules (in case of wet granulation) or sized slugs
(in case of dry granulation) or mixing of ingredients (in case of direct compression), they
are compressed to get final product. The compression is done either by single punch
machine (stamping press) or by multi station machine (rotary press). The tablet press is a
high-speed mechanical device. It 'squeezes' the ingredients into the required tablet shape
with extreme precision. It can make the tablet in many shapes, although they are usually
round or oval. Also, it can press the name of the manufacturer or the product into the top
of the tablet.
Each tablet is made by pressing the granules inside a die, made up of hardened steel. The
die is a disc shape with a hole cut through its centre. The powder is compressed in the
centre of the die by two hardened steel punches that fit into the top and bottom of the die.
The punches and dies are fixed to a turret that spins round. As it spins, the punches are
driven together by two fixed cams - an upper cam and lower cam. The top of the upper
punch (the punch head) sits on the upper cam edge .The bottom of the lower punch sits
on the lower cam edge.
Tablet Presses; A tablet press is a mechanical device that compresses powder into tablets of
uniform size and weight. A press can be used to manufacture tablets of a wide variety of
materials, including pharmaceuticals, illicit drugs such as MDMA cleaning products, and
cosmetics. To form a tablet, the granulated material must be metered into a cavity formed by two
punches and a die, and then the punches must be pressed together with great force to fuse the
material together
A tablet is formed by the combined pressing action of two punches and a die. In the first step of a
typical operation, the bottom punch is lowered in the die creating a cavity into which the
granulated feedstock is fed. The exact depth of the lower punch can be precisely controlled to
meter the amount of powder that fills the cavity. The excess is scraped from the top of the die,
and the lower punch is drawn down and temporarily covered to prevent spillage. Then, the upper
punch is brought down into contact with the powder as the cover is removed. The force of
compression is delivered by high pressure compression rolls which fuse the granulated material
together into a hard tablet. After compression, the lower punch is raised to eject the tablet
Tablet presses consist of;
A. Hoppers, usually one or two, for strong and feeding the formulation to be pressed
B. Feed frames for distributing the formulation to the dies
C. Dies for controlling the size and shape of the tablet

11. D. Punches for compacting the formulation into tablets
E. Cams that act as tracks to guide the moving punches
All other parts of the press are designed to control the operation of the above parts.
Fig 4 – Rotary press
Coating; Tablet coating can be described as a process of applying an edible paint on the surface
of a pharmaceutical dosage form to achieve specific benefits. This is an additional process in
tableting which causes an increase in the cost of tablet production. Coating can be applied to
several kinds of solid dosage forms like tablets, pellets, pills, drug crystals, etc. When a coating
solution is applied to a batch of tablets in a coating pan, the surfaces of the tablets get covered
with a tacky polymeric film. The tablets are then allowed to dry and the film eventually forms a
non-sticky dry surface. The coating technique involves parameters such as the spray pattern,
drop size, and nozzle spacing (in addition to multiple other non-spray related parameters) which
must all be precisely controlled in order to ensure uniform distribution of the coating material
A. Sugar Coating; Tablet coating developed originally from the use of sugar to mask the
taste and provide an attractive appearance to at the core. The process of tablet coating
consists of several steps, which are described below

12. B. Film Coating; As the sugar coating process is very time consuming and is dependent on
the skills of the coating operator, this technique has been replaced by film coating
technology. The process involves spraying of a solution of polymer, pigments and
plasticizer onto a rotating tablet bed to form a thin, uniform film on the tablet surface.
The choice of polymer mainly depends on the desired site of drug release (stomach/
intestine), or on the desired release rate. Some of the non-enteric coating polymers are
Hydroxyproply methyl cellulose (HPMC), Methyl hydroxyethyl cellulose, Ethylcellulose,
Povidone, etc, while the commonly used enteric coating polymers are Cellulose acetate
phthalate, Acrylate polymers (Eudragit L& Eudragit S), HPMC phthalate, etc. An ideal
film coating material should possess the following characteristics.
C. Organic film coating; Currently, the most common technology for coating solid dosage
forms is the liquid coating technology (aqueous based organic based polymer solutions).
In liquid coating, a mixture of polymers, pigments and excipients is dissolved in an
organic solvent (for water insoluble polymers) or water (for water soluble polymers) to
form a solution, or dispersed in water to form a dispersion, and then sprayed onto the
dosage forms in a pan coater (for tablets) and dried by continuously providing heat,
typically using hot air, until a dry coating film is formed. Organic solvent based coating
provides a variety of useful polymer alternatives, as most of the polymers are soluble in
the wide range of organic solvents. However, there are certain disadvantages like they are
flammable, toxic, and costly and possess environmental issues. ICH guidelines also
prefer the avoidance of organic solvents in pharmaceutical dosage formulations
considering products safety profile. So, Pharmaceutical industries are now paying much
attention in developing formulations with aqueous film coating.
D. Aqueous film coating; all above problems with organic solvents resulted in shift to use
of water as the preferred coating solvent. Aqueous-based coatings have been increasingly
used compared with organic-based coatings. The conversion from organic solvent based
coating to aqueous based coating makes the coating process more economical, though
initially it may need a little investment to upgrade the coating facility. The need of this
up-gradation arises due to the need of higher drying capacity (the latent heat of water is
2200kJ as compared to 550kJ for methylene chloride). This implies that one would
require 4 times more energy as compared to organic solvent
Packaging and labeling of tablets
Packaging is the technology of enclosing or protecting products for distribution, storage, sell,
and use. Packaging also refers to the process of designing, evaluating, and producing packages.
Packaging can be described as a coordinated system of preparing goods for transport,
warehousing, logistics, sale, and end use. Packaging contains, protects, preserves, transports,
informs, and sells. In many countries it is fully integrated into government, business, and
institutional, industrial, and personal use.

13. Package labeling or labeling is any written, electronic, or graphic communication on the
package or on a separate but associated label. Your product’s label delivers your sales message.
You can explain what benefits you offer that competitors don’t, for example, or promote a prize
or discount. You also can develop brand goodwill by showing customers you share their values.
For instance, images of happy families, healthy athletes and green pastures each speak to
different types of consumers.
Types of packaging
Blister packing; Blister pack is a term for several types of pre-formed plastic packaging
used for small consumer goods, foods, and for pharmaceuticals. The primary component of
a blister pack is a cavity or pocket made from a formable web, usually a thermoformed
plastic. This usually has a backing of paperboard or a lidding seal of aluminum foil or
plastic. A blister that folds onto itself is often called a clamshell. Blister packs are useful
for protecting products against external factors, such as humidity and contamination for
extended periods of time. Opaque blisters also protect light-sensitive products against UV
rays. Blister packs are used to package products such as toys, hardware, medication, etc.
Many blister packaging machines use heat and pressure via a die to form the cavity or
pocket from a roll or sheet of plastic. In recent years, improvements in cold forming,
specifically allowing steeper depth/angles during forming, which minimizes the amount of
material used for each cavity—have helped this technology increase. The main advantages
of the plastic-based blister pack are its more compact size compared to cold formed
aluminum and its transparency to see the product.
Strip packing; Strip packaging has come to stay in Pharmaceutical, Confectionery,
Engineering and Industrial product sectors. Strip Packaging machines are designed to
handle a wide range of products with utmost precision and speed up to 2400 units per
minute. The Products from the hopper passes through a stainless steel feeding system and
goes to sealing roller cavities where laminated foils, drawn from two rollers, packs and
seals the products in a continuous strip. The strip then passes through vertical and
horizontal Gutter assemblies to deliver the desired sizes of strip packages.

14. Capsule section
In the manufacture of pharmaceuticals, encapsulation refers to a range of dosage forms—
techniques used to enclose medicines—in a relatively stable shell known as a capsule, allowing
them to, for example, be taken orally or be used as suppositories. The two main types of capsules
are:
 Hard-shelled capsules, which contain dry, powdered ingredients or miniature pellets
made by e.g. processes of extrusion or spheronisation. These are made in two halves: a
lower-diameter "body" that is filled and then sealed using a higher-diameter "cap".
 Soft-shelled capsules, primarily used for oils and for active ingredients that are dissolved
or suspended in oil.
Both of these classes of capsules are made from aqueous solutions of gelling agents, such as
animal protein (mainly gelatin) or plant polysaccharides or their derivatives (such as
carrageenans and modified forms of starch and cellulose). Other ingredients can be added to the
gelling agent solution including plasticizers such as glycerin or sorbitol to decrease the capsule's
hardness, coloring agents, preservatives, disintegrants, lubricants and surface treatment.
Industrial filling of hard gelatin capsules
a) Removal of capsules
b) Filling of the bodies
c) Replacement of caps
d) Ejection of filled capsules
 Capsules are delivered into the perforated capsule filling ring. The ring is rotated on a
turntable, and a vacuum pulls the bodies into the lower half of the ring, leaving the caps in
the upper half of the ring.
 The top & bottom halves of the filling ring are separated manually, and the cap half of the
ring is set aside.
 The body half of the ring is then moved to another turntable where it is rotated mechanically
under a powder hopper.
 The hopper contains an auger which feeds the powder into the bodies.

15.  When the capsule bodies are filled, the cap and body rings are rejoined
Few products of Consern Pharma Ltd. And their description
Amitriptyline HCL tablet (cotrip) Amitriptyline HCl, a dibenzocycloheptadiene
derivative, is a white, or practically white, odorless, crystalline compound which is freely
soluble in water and alcohol. Amitriptyline HCl is an antidepressant with sedative effects.
Its mechanism of action in man is not known. It is not a monoamine oxidase inhibitor and it
does not act primarily by stimulation of the central nervous system. Amitriptyline inhibits
the membrane pump mechanism responsible for uptake of norepinephrine and serotonin in
adrenergic and serotonergic neurons
Fluoxetine capsule (cozac) Fluoxetine is a selective serotonin reuptake inhibitor (SSRI)
antidepressant. Fluoxetine affects chemicals in the brain that may be unbalanced in people
with depression, panic, anxiety, or obsessive-compulsive symptoms.
Specification of capsule filling machine
Output 5000 to 6000 capsule per hour
Capsule combination size0/00, size0/1/2, size3/4 and size 5
Machine dimension 395*240*500 mm
Machine weight 45 kg
Shipping dimension 533*400*609 mm
Shipping weight 70 kg

16. Fluoxetine is used to treat major depressive disorder, bulimia nervosa (an eating disorder),
obsessive-compulsive disorder, panic disorder, and premenstrual dysphoric disorder
(PMDD).
Etizolam tablet (etizest) It is a research chemical analogue of the benzodiazepine class of
drugs - the benzene ring being replaced by a thiophene ring, making it a thienodiazepine.
The drug largely shares the effect profile of benzodiazepine drugs (being both hypnotic and
anxiolytic), however studies have shown some major differences between etizolam and the
more traditional benzos used for treatments; it suffers much less from a rapid build-up of
tolerance, and also has a larger range of observed side-effects with abuse.
Gabapentin capsule (neuropin) It is an anti-epileptic medication, also called an
anticonvulsant. It affects chemicals and nerves in the body that are involved in the cause of
seizures and some types of pain. Gabapentin is used in adults to treat neuropathic pain
(nerve pain) caused by herpes virus or shingles
Citicoline Citicoline is the name for cytidine 5′-diphosphocholine (CDP-choline) when
this is used as an exogenous sodium salt. In fact, CDP-choline is an endogenous nucleotide
naturally found in the body where it is an essential intermediate in the synthesis of the
major phospholipid of the cell membranes, phosphatidylcholine (PtdCho). This type of
synthesis is called the Kennedy pathway
Loxapine It is used to treat schizophrenia. It may be given to you for other reasons. Talk
with the doctor. There is a higher chance of death in older adults who take this medicine
(loxapine capsules) for mental problems caused by dementia. Most of the deaths were
linked to heart disease or infection. This medicine is not approved to treat mental problems
caused by dementia.

17. Propanalol Propranolol is a beta-blocker. Beta-blockers affect the heart and circulation
(blood flow through arteries and veins). Propranolol is used to treat tremors, angina (chest
pain), hypertension (high blood pressure), heart rhythm disorders, and other heart or
circulatory conditions. It is also used to treat or prevent heart attack, and to reduce the
severity and frequency of migraine headaches.
Flunarizine Flunarizine is used to prevent migraine headaches with or without aura
(warning signs that occur before the headache begins). This medication should not be
used for treatment of acute migraine headaches (headaches that have already started).
Flunarizine helps to reduce the frequency of migraine attacks and, to a lesser extent, the
severity of the attacks. Flunarizine does not appear to have an effect on how long attacks
last. The effect of flunarizine may not be seen for several weeks. Do not stop taking the
medication due to lack of effect within the first six to eight weeks.
Quality control section
Quality control is the part of GMP concerned with sampling, specification and testing and
with organization; documentation and release procedures which ensure that necessary and
relevant tests are carried out and that materials are not released for sale or supply, until their
quality has been judged satisfactory
Quality Control (QC) laboratory, ensures that the products are pure, safe and effective and are
released only after thorough analysis as per stringent specifications, methods and procedures
developed according to international guidelines viz. EU cGMP, MHRA, WHO, TGA, etc.

18. The QC department performs following activities:
RM/PM analysis

19. Finished product analysis
In check process
The quality control section performs different control measure and test procedures to verify the
product and material quality. The tests are performed by the QC personnel and the results are
matched with a reference standard
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
same time more

20. exacting and sophisticated analytical methods are being developed for their evaluation.
Requirements governing the quality control of pharmaceuticals in accordance wit h the Canadian
Food and D rug s Act are cited and discussed
different types of tests are performed for different material. The types of test performed for each
material is given below-
1) Testing Purified water.
2) Testing Water for Injection.
3) Testing Uniformity of Weight of Tablet.
4) Disintegration Test.
5) Dissolution Test.
6) In Process Quality Control.
7) HPLC – an introduction.
8) Assay of different tablet.
Testing purified water
Physical properties; clear, colorless liquid, odorless, tasteless.
Production; this is produced by distillation – ion exchange – from portable water which complies
with all relevant statutory regulation.
Acidity or alkalinity;
1) To 10 ml freshly boiled and cooled purified water under test in borosilicate glass flask,
add 0.05 ml of methyl red solution. The test is passed if the resulting solution is not red.
2) To 10 ml freshly boiled and cooled purified water under test in borosilicate glass flask,
add 0.1 ml bromothymol blue solution. The test is passed if the resulting solution is not
blue.
N.B tap water showed blue coloration showing alkaline nature. The test is failed.
Calcium and magnesium;
To 100 ml purified water under test, add 2 ml of ammonia buffer (pH 10.0). Then add 50 mg of
Mordant Black II mixture and 0.5 ml of 0.01 M disodium edetate. The test is passed if the a pure
black color is produced
N.B.: Tap water showed a blackish pink color. (Failed).
Chlorides:
To10ml purified water under test – adds 1ml of 2 M nitric acid and 0.2ml of 0.1 M silver nitrate
- the test is passed if the appearance mustn’t change for at least 15 minutes.
Tests;
References; I.P 2007, pg. no. 1870

21. N.B. Tap water showed a whitish coloration. The test is failed.
Ammonia:
Standard: 1 ml of alkaline Potassium Mercuric-iodide solution to a mixture of 4.0 ml of
Ammonium standard solution (1 ppm of NH4) and 16 ml of Ammonia free water (0.2 ppm).
Test: To 20 ml of test water add 1ml of alkaline potassium mercuric-iodide solution and allowed
to stand for 5 minutes.
Results: View vertically - solution is not more intensely colored than standard prepared at the
same time.
Sulphates: To 10 ml of test water add 0.1 ml of 2 M HCl and 0.1 ml of Barium Chloride
solution. The test is passed if the appearance does not change for at least 1 hour.
Oxidisable Substances:
To 100 ml of test water add 10 ml of 1 M H2SO4 and 0.1 ml of 0.02 M Potassium Permanganate
- Boil for 5 mints. The test is passed if the Solution remains faintly pink.
Instruments and Devices seen:
1) Hot Air Oven.
2) Dissolution Test Apparatus.
3) Vacuum Oven.
4) Bulk Density Apparatus.
5) Membrane Filter.
6) Muffle Furnace.
7) Centrifuge.
8) Magnetic Stirrer.
9) Ultrasonic Bath.
10) UV Cabinet.
11) Bursting Strength Test Apparatus.
12) UV-VIS Spectrophotometer.(Ultra Violet Visible)
13) FT-IR Spectrophotometer.(Fourier Transform Infrared).
14) Karl Fisher Titration.
15) HPLC system
16) Polarimeter
17) Digital pH meter
18) Magnetic Stirrer etc.
Testing Uniformity of Weight of Tablets
Product: Dizone tablets.
Batch no. : GD-16893 Mfg. Date: 06/11 Exp. Date: 05/11
Data Obtained:
a) Weight of 20 tablets = 12.8867 g

22. b) Average weight = 12.8867/20
= 0.6443g
= 0.6443*1000mg = 644.3mg
Serial Number Weight(G) Weight – paper weight(G)
(paper weight = 0.1112G)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
0.7623
0.7526
0.7589
0.7406
0.7530
0.7558
0.7567
0.7567
0.7553
0.7581
0.7493
0.7460
0.7559
0.7408
0.7503
0.7687
0.7576
0.7523
0.7519
0.7416
0.6511
0.6414
0.6477
0.6294
0.6418
0.6295
0.6418
0.6446
0.6411
0.6469
0.6455
0.6381
0.6384
0.6447
0.6296
0.6391
0.6575
0.6464
0.6561
0.6464
Calculation
According to I.P specification;
1) Average weight = 645mg (+)(-)10mg
2) For maximum & minimum variation;
Tablet weight variation specified
Below 80mg _ (+) (-) 10%
80 – 250mg _ (+) (-) 7.5%
Above 250mg _ (+) (-) 5%
Result
1) Average weight = 644.3mg (passed)
2) Minimum weight= 0.6294g (Sl. No. 24) =629.4 mg
So, minimum variation = (644.3-629.4) x 100/644.3
3) Maximum weight = 0.6575g (Sl. No. 19) = 657.5 mg
So, maximum variation = (657.5-644.3) x 100/644.3
= +2.05% (within limit passed)

23. Sampling
 The process of sampling is done by the QC dept. after raw material enters the store and
UNDER TEST label is pasted on it by the officials in the raw material store.
 For active pharmaceutical ingredient 100% sampling must be done.
 For inactive, pharmaceutical ingredient sampling is done.
 No. of container to be sampled = total no. of container + 1
Product; disulfiram (raw material form)
Sampling is done with help of sampling rod.
Labels
Maintenance section
Maintenance Section is the backbone of a pharmaceutical industry which provides a suitable
environment for manufacturing of different forms of drug. They regulate all the physical,
instrumental requirements of a pharmaceutical industry.
Instruments, operated by maintenance section are as follows:-
Under test
Material name;
Material code no.
Batch no;
GRN no;
GRN date;
Quantity;
NO. of containers;
MFG date;
EXP date;
Manufacturer;
Supplier
Prepared by;
Checked & verified by;
Sampled
Sampled by;
Sign with date;
Approved
A.R no;
Potency;
Approved by;
Sign with date;

24. Ground floor-
 Vapour absorption machine, capacity=150 TR, model no-A2135X
 Steam boiler-RXD 850, capacity=850 kg/hr
 DM water plant-NGMF 30,CA 34/1-1.75M/hr
 Reciprocating air compressor 2545 D10, capacity=35CFM
 Refrigerated Air dryer IR32R, capacity=3.2 M3/min
 Air receiver tank, capacity=1000 ltr
 Screw air compressor UPS – 18 -7, capacity=109 CFM
Top floor
 WFI plant- multicolumn distilled water still plant 300 WS/ capacity-300 ltr/hr.
 WFI storage tank
 Purified water storage tank/ capacity-
capacity-300kg/hr
 FRP pressure vessel DM/240 MB/volume-75ltr
 RO water plant RO 219/capacity-0.5 M3/min.
Conclusion
Industrial training is very much essential for Pharmacy Students. It is also a great opportunity to
acquire practical knowledge. During my training period, in the industry I acquired lots of
experiences in Pharmaceutical Production and Production management. This will help me to
clarify my theory knowledge. I hope and pray that it will help me much in my future profession.
During our training period, we had seen the various instruments and apparatus in the industry.
The highly sophisticated instruments that work precisely must be operated with intense care for
optimum use. We could acquire a lot of information regarding the latest instruments and their
working procedures.
It was taught to us that, the CGMP guidelines are to be strictly followed in the industries in each
and every section. But the same was seen not to be satisfactory in the Consern Pharma,
LUdhiana. The workers were seen dealing the active medicaments with bare hands. The quality
control section was also of substandard. Due to lots of vacancy of chemists, they did not do the
basic tests of the solid dosage forms like assays, disintegration test, dissolution tests etc. They are
doing the same only on the paper documents, not in practice. Hence it can be said that, the
authorities are not paying much importance on the quality of the products.
Apart from all that, the training was very interesting with lots of things to be learned. It helped us
to acquire knowledge on punctuality, regularity and working environments in industries. The

25. friendly working environment in ozone pharmaceuticals will remain in our mind in near future.
Hence, we can say that our goal of attending the industrial tour is fulfilled. We acknowledge the
great help of Consern Phrama Limited