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Training Report |

Cadila
Pharmaceutical
Limited
Anas Haruna Indabawa
BARCHALOR OF PHARMACY
ADDRESS: Naini, Allahabad, U.P, INDIA. 211007.
ID NUMBER: 13BPH053
JUNE- 2016

Training Report | Cadila Pharmaceutical Limited


CERTIFICATION

This is to certify that Mr. Anas Haruna Indabawa, a student from the Department of
Pharmaceutical Sciences, Sam Higginbottom Institute of Agriculture, Technology & Sciences
Allahabad has Completed his Industrial Training from
to
at Cadila
Pharmaceuticals Limited, Samba, State of Jammu & Kashmir in integration of B.Pharm
degree Course.

We wish him all the success in life


Seal of the company

Signature of the competent authority


Of the institute/organisation

Place:
Date:

Sam Higginbottom Institute of Agriculture, Technology & Sciences (SHIATS) Allahabad.

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Training Report | Cadila Pharmaceutical Limited


ACKNOWLEDGEMENT
I consider it a great privilege & honor to have had the opportunity to undergo the
industrial training program in Cadila Pharmaceutical Limited, Samba (Jammu & Kashmir). I
hereby wish to take the opportunity to express my gratitude to all members of Human Resource
Department (HR), especially Mr. K. S Chauhan (General Manager HR), Mr. Ranbir Singh
(Assistant Manager HR), and Sourabh bhattr. I express my special thanks and gratitude to Mr.
Ranbir for taking care of all our official requirements.
I convey my heartiest thanks to Mr. G.P Chaurashia (Vice presedentcadila pharma. &
Plant Head Gen. Manager Cadila, Samba.),Mr. Dinesh Jain (Deputy General Manager&
Production Head)Mr. ManojChaurashia (Senior Manager Production Dept. Line C), Mr.
Anil kumarsaini (Head of Dept. QA/QC), Mr. Mohan S. Pundik (Asst. H.O.D QA/QC) for
guiding, and encouraging me to carry out my industrial training successfully. Aspecial regards to
Mr. G.P Churashia for allowing me to undertake my summer training at this great and reputed
organization like Cadila pharma. Ltd.
I owe deepest gratitude to Dr. Himanshu Pandey (Department of Pharmaceutics) Sam
Higginbotom Institute of Agriculture, Technology & Sciences (SHIATS) who work tirelessly
to make this training program possible. I also extend my thanks to Prof. (Dr.) Arvind Dayal
(Dean faculty of Health science SHIATS), Prof. (Dr.) G.S Shukla (Associate Dean), Dr.
AmitaVerma (Head of Dept., Pharmaceutical Science, FHS, SHIATS) for their help.
I extend my regards to all Nigerian students in (SHIATS), especially Abdulsalam M.
Uba, Isah Hassan Abubakar and Yusuf Baba Dala whom we undergo the training together at
cadila pharma.
My very special thanks to my parent for giving me a good background that helps me
benefits many achievements of my life.
Finally, I wish to convey my deep thanks to all staffs in different departments for their
kind cooperation, guides, supports, encouragements for me to get vast knowledge and ideas
regarding many sectors to improve my educational carrier and to have excellent training practice.
Special regard to Anupam Rai (production Dept. line C); Rano Yadav, Mohini sharma, Diguijay
Rai, Sanjay Yadav, Ranveer singh (QA/QC); Nisha Tickoo (Microbiology Dept.);
Vidushisharma, Rhythm parghal, Aditya Verma (Packaging Dept); Ramandanjha (Raw material
store); Rahul sharma, Rajesh sharma (sofgel Dept.) for their kindness during the tenure of my
training program.I also extend my regard to Mr. Raul kashaf (Engineering Dept).

Sam Higginbottom Institute of Agriculture, Technology & Sciences (SHIATS) Allahabad.

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Training Report | Cadila Pharmaceutical Limited


PREFACE
Pharmacy is the Art and Science of preparing and dispensing drug. It is the
health profession that links health sciences with chemical sciences and aims to
ensure the safe and effective use of pharmaceutical drugs.So it is a 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
periods of four week in various pharmaceutical industries in India.
I was directed to undergo my industrial training at CADILA
PHARMACEUTICAL LIMITED and this report contains a brief description of the
above pharmaceutical industry which was observed during the training program.

Sam Higginbottom Institute of Agriculture, Technology & Sciences (SHIATS) Allahabad.

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Training Report | Cadila Pharmaceutical Limited


TABLE OF CONTENT
S/N
CONTENT
1
Profile of Organisation
- About Cadila
- Vision
- Mission
- Our Inspiration
- Research
- Approved patents
- Formulations

PAGE
5-7

8-15

Production Section
- General Instructions and Precautions
- Granulation
- Compression
- Coating
- Packaging and Labelling
- Encapsulation
Soft Gelatin and Hospicon Section
- Soft gelatin
- Hospicon
Quality Control & Quality Assurance Section
- Size and Shape
- Organoleptic Property
- Hardness and friability
- Weight Variation
Microbiology Section
- Microbiological Testing of Non-sterile product
- Sterility Testing
- Validation
Engineering Section
- Electricity Unit
- Water Treatment System
- Water Softening Unit
- Chilling/Steam Unit
- Air Handling Unit (AHU)
- Effluent Treatment Plant (ETP)
Raw Material and Finished Goods Section

16

17-19

20-23

24-27

28-30

Sam Higginbottom Institute of Agriculture, Technology & Sciences (SHIATS) Allahabad.

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Training Report | Cadila Pharmaceutical Limited

- Raw material
Receiving
Sampling
Storing
Dispensing
- Finished goods
Conclusion

31

Bibliography

32

Sam Higginbottom Institute of Agriculture, Technology & Sciences (SHIATS) Allahabad.

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Training Report | Cadila Pharmaceutical Limited


PROFILE OF ORGANIZATION
ABOUT CADILA
Cadila Pharmaceuticals Ltd. is one of the largest privately held pharmaceutical
companies in India, headquartered at Ahmedabad, in the State of Gujarat. Over the last six
decades, the company has been developing and manufacturing pharmaceutical products in
India and selling and distributing these in over eighty-five other countries around the world.
Focused strongly on Innovation and Research, the company is present in more than fortyfive therapeutic areas spread across twelve specialities, including cardiovascular, gastrointestinal,
analgesics, haematinics, anti-infectives and antibiotics, respiratory agents, antidiabetics and
immunologicals. At Cadila Pharmaceuticals, Research and Development is at the core of all its
initiatives, be it Biotechnology, APIs, Formulations, Plant Tissue Culture or Phytochemistry.
More than 300 scientists in its various Research and Development setups reinforce the
competitiveness of research in the therapeutic areas which have high unmet medical
needs.Cadila Pharmaceuticals Excellence in manufacturing facilities is central to Cadila
Pharmaceuticals. The companys formulations manufacturing plant at Dholka near Ahmedabad,
Gujarat is spread over hundred acres of land. This state-of-the- art facility is not only impressive
in size, but is also USFDA approved.
The second formulations manufacturing facility is located at Samba in Jammu and
Kashmir. The facility meets most of the stringent quality standards across the globe to produce
tablets, capsules, soft and hard gelatin capsules, liquids and orals.Two Active Pharmaceutical
Ingredient (API) manufacturing units at Ankleshwar, Gujarat manufacture a wide range of APIs
and intermediates including many USFDA-certified products.
The company has strong foothold in the African continent through its formulation
manufacturing facility at Addis Ababa in Ethiopia.
VISION
Our vision is to be a leading pharmaceutical company in India and to become a
significant global player by providing high quality, affordable and innovative solutions in
medicine and treatment.
MISSION
We will discover, develop and successfully market pharmaceutical products to prevent,
diagnose, alleviate and cure diseases. We shall provide total customer satisfaction and achieve
leadership in chosen markets, products and services across the globe, through excellence in
technology, based on world-class research and development. We are responsible to the society.
We shall be good corporate citizens and will be driven by high ethical standards in our
practices.

Sam Higginbottom Institute of Agriculture, Technology & Sciences (SHIATS) Allahabad.

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Training Report | Cadila Pharmaceutical Limited


OUR INSPIRATION
Mr. I A Modi is the Founder Chairman of Cadila Pharmaceuticals Ltd.
Born in a small village of Hansot of Bharuch district in South Gujarat on February 18,
1926, Mr. Modi has left a long lasting impact on Indian Pharmaceuticals industry.
Mr. Modi is revered in the Indian Pharmaceutical Industry as the Champion of Indian
Patents Act, 1970 which helped the Indian Pharmaceuticals Industry in attaining its present
global status. He played a major role in giving shape to the 1986 Drug Policy of Government of
India.His contributions are widely acclaimed in the industry circles. Mr. Modi represented the
National Working Group on Patent Laws, India (NWGPL) and Indian Drug Manufacturers
Association (IDMA) on the subject Patent Regime proposed in the Uruguay Round at Delhi
1993. He effectively championed the cause of national sector of the pharma industry and became
a rallying point against the new patent regime during its consideration stages.
Under his leadership Cadila Pharmaceuticals achieved new milestones and offered
many innovative and firsts in the world medicines to the mankind including Rabeprazole in IV
form for upper GI bleeding, Polycap for prevention of cardiovascular diseases, Risorine with
booted Rifampicin for the treatment of Tuberculosis etc. He also has the credit to bring cutting
edge technology VPL Virus Like particles) for vaccine manufacturing in India. Following in his
vision, Cadila Pharmaceuticals continues to innovate and bring affordable medicines for the end
users.Mr. Modi has been a champion of Corporate Social Responsibility long before the concept
became popular. In 1985, he established Kaka-Ba hospital with ultramodern facilities at a remote
village to serve the needy poor patients.
RESEARCH
Spread over more than 1,05,000 sq. ft. area, Cadila Pharmaceuticals R & D facilities,
recognized by the Department of Science & Technology, Government of India, are manned by
more than 300 scientists. A centralized Quality Control & Analytical Research Laboratory has
been set up to meet the domestic and international quality standards. The Company has expanded
operations by building further on already existing set-up by investing in new premises, to include
modern, state-of-the-art amenities. One of the few companies in the country carrying out
collaborative research, Cadila Pharmaceuticals taps the best scientific talent in the country and
has collaborations with more than 30 leading Research and Development centers in India.

1177 Formulations registered worldwide


148 API Drug Master Files (DMFs) submitted
52 patents granted and 405 patent applications filed globally

APPROVED PATENTS

Intravenous composition of Rabeprazole


Solid oral composition contain five actives in one capsule
Pharmaceutical composition of novel vaccine adjuvants and its method of treatment

Sam Higginbottom Institute of Agriculture, Technology & Sciences (SHIATS) Allahabad.

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Training Report | Cadila Pharmaceutical Limited

New molecular entity on diabetes

FORMULATIONS
Our extensive range of finished dosage formulations covers every aspect of human life.
Our basket of formulations contain more than 850 products in several forms belonging to 45
therapeutic segments and 12 specialities including cardiovascular, gastrointestinal, analgesics,
haematinics, anti-infectives and antibiotics, respiratory agents, antidiabetics, immunogicals and
oncology. The manufacturing expertise is available for almost all dosage forms including sterile
as well as non-sterile products. Formulations have three manufacturing facility in the state of
Gujarat, Jammu (India) and Ethiopia. All of which are approved by all prominent international
regulatory bodies, including USFDA

Sam Higginbottom Institute of Agriculture, Technology & Sciences (SHIATS) Allahabad.

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Training Report | Cadila Pharmaceutical Limited


PRODUCTION SECTION
GENERAL INSTRUCTIONS AND PRECAUSIONS

Ensure area and equipment cleanliness before starting the manufacturing operations.
Check and ensure that all manufacturing equipment and other required accessories are
clean ready for use.
Wear gloves and nose mask during all manufacturing process.
Counter check the weights of all ingredients before using in the batch
Get line clearance from QA for manufacturing.
Air handling unit (AHU) system should be kept ON throughout the manufacturing
process.
Temperature should be kept between 25C 2C and relative humidity should be kept
between 5010%.
Ensure that only QC approval purified water is being used for manufacturing purpose
Always transfer solution to the manufacturing vessels through 20 meshes.
During the preparation of this product, no other product processing should be done in the
same area.
Whenever sifting through SS mesh is involved; check the mesh integrity before and after
use.
All critical aspects during manufacturing like temperature, duration of mixing, weight,
etc. must be checked and recorded by the supervisor.
Supervisor to ensure completion of all in-process records during various stages of
manufacturing operations till completion of the batch.
Release from QA should be taken from all in-process tests mentioned in batch
manufacturing record
No over writing is allowed in batch manufacturing record. If initial data is wrong entered,
cancel the data by single stroke arrow and put initials. Record reasons for change as footnote on the same page.
All the details whatever is necessary should be recorded in batch manufacturing record
(BMR).
Send a test request form to QC after manufacturing is completed
Check all polyethylene bags before and after material loading for black particles and
sealing.
Check calibration of respective equipment/machine before use.

Tablet component and Additives


Active Ingredients: Aceclofenac,olmesartan, montelukast, loperamide, paracetamol,
chlozoxazole, seratiopeptidase, sesquihydrate AF, domperidone, pantoprazole, ranitidne,
Sam Higginbottom Institute of Agriculture, Technology & Sciences (SHIATS) Allahabad.

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Training Report | Cadila Pharmaceutical Limited


amiodorone, fexofenadine, amikacin, dexamethasone, ciprofloxacin, fluconazole, vitamin B3
granule etc.
Non-active Ingredients
a. Diluents: starch, lactose, mannitol, sorbitol
b. Binders: acacia, gelatin, Tragacanth, Calcium lactate trihydrate granular N.F, Starch
paste, polyvinyl pyrollidone, sodium alginate
c. Lubricant: Stearic acid, Magnesium stearate, Calcium stearate and Talk
d. Disintegrates: Starches and most common disintegrants
e. Colous: D&C and FD&C Dyes and lacquers

GRANULATION
Departments

Line A : for tablets preparation


Line B : for tablets preparation
Line C : for tablets preparation
Line D : for tablets and capsule
Line E : for tablets preparation (Dexamethasone)
Line L : for liquid preparation

Unit Operation
There are three methods of preparing Tablets. These are:

Wet granulation
Dry granulation (also called slugging) and
Direct compression

Each of these methods has its advantages and disadvantages. The first two step of milling
and mixing of the formulation are identical, but thereafter the processes differ, Each
individual operations of the process is known as unit operation.
Step in different methods of manufacture
WET GRANULATION
o
o
o
o
o

Mixing of drugs and excipients


Mixing of milled powder
Preperation of Binder solution
Mixing of binder solution with powder mixture to form wet mass
Coarse Screening of wet mass using 6-12 mesh

Sam Higginbottom Institute of Agriculture, Technology & Sciences (SHIATS) Allahabad.

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Training Report | Cadila Pharmaceutical Limited


o
o
o
o

Drying moist granules


Screening dry granules with lubricant and disintegrants
Mixing screened granules with lubricant and disintegrants
Tablet compression

DRY GRANULATION
o
o
o
o
o
o

Milling of drugs and excipients


Mixing of milled powders
Compression into large, hard tablets called slugs
Screening of slugs
Mixing with lubricants and disintegrating agents
Tablet compression

DIRECT COMPRESSION
o Milling of drugs and excipients
o Mixing of ingredients
o Tablet compression
Equipments

Rapid Mixing Granulator (RMG)


Steam Kettle
Fluid Bed Dryer (FBD)
Vibro Sifter with Loader
Tippler and Co-Mill
Rimek Communiting Mill
Conta Blender
Compressor

Rapid Mixing Granulator (RMG)


RMG was developed for pharmaceutical and chemical industry. With the help of MRG
wet sifting is generally no longer necessary. After the mixing of dry components, wet granulation
occurs (without transfer of dry mixture) producing loose granules in RMG. RMG is specifically
designed to meet the GMP requirements of the pharmaceutical industries.
Fluid Bed Dryer (FBD)
In FBD, the fluidized air steam is introduced by a fan or a blower mounted at the top of
the apparatus. The air is heated to a required temperature in the air heater and flows upwards
through the wet materials, which remains in a drying chamber fitted with a wire mesh supported

Sam Higginbottom Institute of Agriculture, Technology & Sciences (SHIATS) Allahabad.

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Training Report | Cadila Pharmaceutical Limited


at the bottom. By this process, the material is suspended and agitated in a warm air steam while
the granulation is maintained in motion.
Vibro Sifter with Loader
Sifter is an instrument used to sieve the ingredients of the tablet with a replicable mess
ware. In this technique, particles of power mess are placed on a screen made of uniform aperture.
The sifter is attached with vibrator that helps in sieving the materials through the meshwork. The
mechanism of action is to loosen the parking of particle in contact with screen surface,
permitting entrapped sub sieve particles to the screen surface.
Communiting Mill
Communiting mill is used for wet and dry granulation, pulverization or dispersion of
product or ingredients in pharmaceutical, chemical, bulk drug food and other industries. It
consists of stainless steel hopper through which the product slide into the enclosed chamber,
where it is milled between beater and reduced to required size and finally collected in a
container.

Conta Blender
The Conta blender gives better efficiency as compared to conventional blenders.
Tumbling principle in partial void enables the homogeneous mixing of active ingredients,
additives and raw materials. The rotation of bunker in a diagonally eccentric plane ensures
efficient blending.

COMPRESSION:
This step involves consistent flow of an adequately lubricated, uniform blend, into dies
where the granules are being compressed into tablets. Compression is to be carried out as per
batch manufacturing record. Collect the samples at various stages i.e. at start up, high RPM, low
RPM, low weight at target speed, high weight at target speed, initial, middle and end of
compression and carry out the testing of content uniformity and physical parameters such as
hardness, thickness, friability etc.In compression stage three batches i.e. Batch No I, II and III
shall be considered for validation. Compression results of all the batches are well within the
acceptance criteria results of the compression at different speed, low weight at target speed, high
weight at target speed, initial, middle and end of the compression.

Sam Higginbottom Institute of Agriculture, Technology & Sciences (SHIATS) Allahabad.

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Training Report | Cadila Pharmaceutical Limited


Compressor
For increase production, rotary machine offers a great advantage. A head carrying a
number of sets of punches and dies revolves continuously while tablet granulation runs from the
hopper,through a feed frame and into the dies placed in a large, steel plate revolving under it.
This method promotes a uniform fill of the die and therefore an accurate weight for the tablet.
Compression takes place as the upper and lower punches passes between a pair of rollers. This
action produce a squeezing effect on the material in the die cavity from the top and bottom and
so gives a chance for the entrapped air to escape. The lower punch lifts up and ejects tablet. The
punches and dies can be removed for inspection, cleaning and inserting different sets to produce
a great variety of shapes and sizes.

COATING
Tablets may be coated for a variety of reasons, including protection of the ingredients
from air, moisture, or light. Tablets are also coated to protect the drug against decomposition or
to disguise or minimize the unpleasant taste of certain medicaments. Coating also enhances the
appearance of tablets and makes them more readily identifiable. In addition, coatings can be
resistant to gastric juices but readily dissolve in the small intestine. These enteric coatings can
protect drugs against decomposition in the acid environment of the stomach.
Coating is to be carried out as per batch manufacturing record. Samples are collected at
the end of coating stage and carried out the testing of content uniformity and identification tests,
related substances, individual impurities, and physical parameters such as hardness, thickness,
friability, etc. In coating stage three batches i.e. Batch No I, II and III shall be considered for
validation. Coating results of all the batches are well within the acceptance criteria.
Types of coating include:
Sugar coating
Film coating
Modified coating
Sugar Coating:- The sugarcoating process involves building up layers of coating material on the
tablet cores as they are tumbled in a revolving pan by repetitively applying a coating solution or
suspension and drying off the solvent. Before sugarcoating, the core is coated with a sealing coat
of shellac, PVP*-stabilized types of shellac, or other polymeric materials, such as cellulose
acetate phthalate and polyvinyl acetate phthalate. The next stage is to build up a sub coat that
will provide a good bridge between the main coating and the sealed core, as well as round off
any sharp corners. This step is followed by smoothing or grossing. The finishing stage is
accomplished by again applying one or two layers of clear syrup. The tablets are then left for
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Training Report | Cadila Pharmaceutical Limited


several hours before being transferred to the polishing pan. The polish is a dilute wax solution
(e.g., carnauba or beeswax in petroleum spirit) applied sparingly until a high luster is produced.
Film Coating :- Film coating has increased in popularity for various reasons. The film process is
simpler and, therefore, easier to automate. It is also faster than sugarcoating, since weight gains
of only 2 to 6% are involved, as opposed to more than 50% with sugarcoating. Two major
groups of film coating materials may be distinguished:
(a) Those that are non-enteric and, for the most part, cellulose derivatives, and
(b) Those that can provide an enteric effect and are commonly esters of phthalic acid.
Films may contain a plasticizer that prevents the film from becoming brittle with
consequent risk of chipping. Until recently, alcohols, esters, chlorinated hydrocarbons, and
ketones have been among the most frequently used types of solvents. However, because of
increasing regulatory pressures against undesirable solvents, there has been a pronounced trend
toward aqueous film coating.
Modified-Release Coating: - A coating may be applied to a tablet to modify the release pattern
of the active ingredient. Two general categories, enteric coating and controlled-release coating,
are distinguished. The former are insoluble in the low pH environment of the stomach but
dissolve readily in the small intestine with its elevated pH. They are used to minimize irritation
of the gastric mucosa by certain drugs and to protect others that are degraded by gastric juices.

PACKAGING AND LABELLING


Packing is the technology of enclosing or protecting product for distribution, storage, sale,
and use. Packaging is 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. It is sometimes convenient to categorize packages by
layer or functions.
o Primary Packaging
o Secondary Packaging
o Tertiary Packaging
PRIMARY PACKAGING: Primary packaging is the material that first envelope the product and
holds it. This usually is the smallest unit of distribution or use and is the package which is in
direct contact with the content.
SECONDARY PACKAGING: Secondary packaging is outside the primary packing, and may be
used to prevent pilferage or to group primary packages together.

Sam Higginbottom Institute of Agriculture, Technology & Sciences (SHIATS) Allahabad.

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Training Report | Cadila Pharmaceutical Limited


TERTIARY PACKING: These are used for bulk handling, warehouse storage and transport
shipping. The most common form of palletized unit load that packs tightly into containers.
TYPES OF PACKAGING
a. Blister Packing: This is useful for packaging of unit dose of pharmaceuticals. This
packing mode has been used extensively for several good reasons. It is a packaging
configuration capable of providing excellent environmental protection, coupled with an
aesthetically pleasing and efficacious appearance. It also provides user functionally in
terms of convenience, child resistance and now temperature resistance. The blister
package is formed by heat softening a sheet of thermoplastic resin and vacuum drawing
the softened sheets of plastic into a contoured mould. After coming, the sheet is released
from the mould and proceeds to the filling station of the packaging machine. The semirigid blister previously formed, is filled with the product and lidded with a heat sealable
backing material. The backing material can be either a push through or peelable type.
For a push through type of blister, the backing material is usually heat seal coated
aluminum foil.
b. Strip Packing:The strip packing is done by aluminum foil or glassine poly paper. A
strip package is formed by feeding two webs of a heat sealable flexible film through
either a heated crimping roller or a heated reciprocating platen. The product is dropped
into the pocket formed prior to forming the final set of seals. A continuous set of packets
is formed, generally several packets wide depending on the packaging machines
limitations. The strip of packets is cut to the desired number of packets in length. The
strips formed are usually collected and packed into a folding carton. The product sealed
between the two sheets of film usually has a seal around each tablet, with perforations
usually separating adjacent packets.
c. Bulk Packing: The packaging of the final product is done in paper cartons, manually,
and is finally sealed using an automatic sealer. The machine can seal cartons.
PACKING MACHINERIES

Accumulating and collating machine


Blister packs, skin packs and vacuum packing machines
Converting machine
Filling machine
Linear vibrator
Coding, printing, marking, stamping and imprinting machine
Package filling and closing machine
Palletizing, depalletizing, unit load assembly
Packing sealing machine
Conveyor belts

Sam Higginbottom Institute of Agriculture, Technology & Sciences (SHIATS) Allahabad.

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Training Report | Cadila Pharmaceutical Limited

Label dispenser: Domino printer


Weighing machine: check weigher
Wrapping machine
Carton machine
Other specialty machinery: Slitters, perforating, laser cutters, parts attachment, etc.

ENCAPSULATION
Encapsulation is the process of manufacture of capsules. Capsules are solid dosage forms
in which the drug substance is enclosed in either hard or soft, soluble form of gelatin.
TYPES OF CAPSULES
Hard gelatin capsule
Soft gelatin capsule
HARD GELATINE CAPSULE
It is referred to as dry filled capsule; consist of two sections, one slipping over the other,
thus completely surrounding the drug formulation.
SOFT GELATING CAPSULE
It is a soft, globular, gelatin shell, somewhat thicker than that of hard gelatin capsules.
The gelation is plasticized by the addition of glycerin, sorbitol, or a similar polyol.
The hard capsule is also called two pieces as it consists of two pieces in the form of
small cylinders closed at one end, the shorter piece is called the cap which fits over the open
end of the longer piece, called the body. The soft gelatin capsule is also called as one piece.
Capsules are available in many sizes to provide dosing flexibility. Unpleasant drug tastes and
odors can be masked by the tasteless gelatin shell. The administration of liquid and solid drugs
enclosed in hard gelatin capsules is one of the most frequently utilized dosage forms.
Filling of hard gelatin capsules:
a) Removal of caps
b) Filling of the bodies,
c) Replacement of caps, and
d) Ejection of filled capsules

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Training Report | Cadila Pharmaceutical Limited


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.
When the capsule bodies are filled, the cap and body rings are rejoined.
Capsules equipment seen

Medicament preparation vessel


Gelatin preparation vessel
Colloidal mill
Water storage tank
Gelatin holding tank
Encapsulation machine
Tumbler dryer
SS trolley
Auto sorting machine
Weighing balance
Bottle filling/ capsule sealing machine

SOFT GELATIN AND HOSPICON SECTION


SOFT GELATIN
A softgel is an oral dosage form\ for medicine similar to capsules. They consist of a
gelatin

based

shell

surrounding

liquid

fill.

Softgel

shells

are

combination

of gelatin, water, opacifier and a plasticiser such as glycerin or sorbitol. Softgels are produced in
a process known as encapsulation using the Rotary Die Encapsulation process invented by
Robert Pauli Scherer. The encapsulation process has been described as a form/fill/seal process.
Two flat ribbons of shell material are manufactured on the machine and brought together on a
twin set of rotating dies.
Cadilapharmaceuticals commissioned a modern sophisticated manufacturing facility for
soft gelatin capsules at jammu complex. Designed to meet the most stringent international
standards, all operations in this plants from encapsulation to packaging, are carried out under
class 100,000. All systems are validated to meet international FDA standards, and the present
capacity of one million capsules per day can be doubled with marginal investments.
Sam Higginbottom Institute of Agriculture, Technology & Sciences (SHIATS) Allahabad.

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Training Report | Cadila Pharmaceutical Limited


HOSPICON
The wide range covers Orthoset, a leading plaster of paris bandage; Duralite, a fibre
glass-based synthetic cast bandage; Glotex examination gloves and Surgitex surgical gloves,
both made of high-grade double-centrifuged latex; Opstic adhesive tapes,
Dermaporehypoallergic tapes, Dermasilk wound dressing and Castinetguaze bandage. Other
specialty products includes Cadi-V infusion sets and Bioflon I.V cannula; and Softcrepe and
cotton crepe bandages.Besides these, the company has entered into the agreement to lunch
modern wound cares including Hydrogel.

Equipment seen in Hospicon Section

Mass mixer
Bandage making machine
Bandage cutting machine
Bandage coating machine
Dryer / Dehumidifier
Pulling machine
Slitting machine
Conveyor

QUALITY CONTROL AND QUALITY ASSUARANCE 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.
One of the most important elements in QC laboratory programme is the quality and
assurance of the standard, which are used. The standard can be broadly defined into two
categories

Reference standard or primary standard


Working standard or secondary standard

The working standard are those obtained from reliable source and whose purity and
strength have been optimized through test, generally compared with the reference
standard. The quality control section performs different control measure and test
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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 exacting and sophisticated analytical methods are
being developed for their evaluation
Different types of test are performed for different material. The types of test performed for each
material are as follows1.
2.
3.
4.
5.
6.
7.

Testing Purified water


Assay of different tablet
Disintegration Test
Dissolution Test
In Process Quality Control
HPLC High Pressure Liquid Chromatography
Testing Uniformity of Weight of Tablets

EVALUATION

SIZE AND SHAPE: - Thickness: 5% of standard value control to facilitate packaging.


shaped tablet requires slotted punches because of the non-uniformity force during
compression
ORGANOLEPTIC PROPERTY: -Color of product must be uniform. Non uniformity of
color on the tablet is called Mottling. Instrument used to measure color uniformity and
quantitative measurement includes
Reflectance spectrophotometer
Micro reflectance photometer
Tristimulus Collimating
HARDNESS AND FRIABILITY:- Both for tablet strength testing. Force required to
break a tablet in a diametric compression test is called hardness, also called tablet
crushing strength.
Friability is the resistance shown by the tablet during packing and transshipment.
Friability tester:
Roche friabilator
Revolution at 25 rpm for 4 minutes (100 rev.)
Dropping from 6 inches

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%Friability = (Initial weight- Final weight)/ Initial weight 100

WEIGHT VARIATION:- 20 tablets are weighted


Meet USP test: Not more than 2 tablets are outside of limit if no tablet differ more than 2
times the percentage limit.
IP
Less than 85mg
85mg-250mg
Greater than 250mg

%
10%
7.5%
5%

USP
Weighing 130mg or less
Weighing 130-324mg
Weighing 324mg or more

DISINTEGRATION
6 test tube and 3 inch long
10 mesh screen
1L beaker of water (0.1N HCL) simulated gastric fluid or simulated intestinal
fluid
Temperature 372C
Up and Down from 5-6 cm
Frequency 28-32 cycle/min
Tablet should remain 2.5cm below the surface of liquid on their upward movement and
same for downward movement. The potency of tablet is expressed in mg ,g, g. Official
range is not less than 95%. Majority of tablets has their disintegration time of 30 min.
Instruments and Devices seen in QA/QC

Hot Air Oven.


Dissolution Test Apparatus.
Vacuum Oven.
Bulk Density Apparatus.
Membrane Filter.
Conductivity meter
Halogen moisture balance
Gas chromatograph
Melting point detector
Viscometer
Muffle Furnace.
Centrifuge.
Magnetic Stirrer.

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Ultrasonic Bath.
UV Cabinet.
Bursting Strength Test Apparatus.
UV-VIS Spectrophotometer. (Ultra Violet Visible)
FT-IR Spectrophotometer.(Fourier Transform Infrared).
Karl Fisher Titration.
HPLC system
Polarimeter
Digital pH meter

MICROBIOLOGY SECTION
The Guide to the Inspection of Pharmaceutical Quality Control Laboratories provided
very limited guidance on the matter of inspection of microbiological laboratories. While that
guide addresses many of the issues associated with the chemical aspect of laboratory analysis of
pharmaceuticals, this document will serve as a guide to the inspection of the microbiology
analytical process. As with any laboratory inspection, it is recommended that an analyst
(microbiologist) who is familiar with the tests being inspected participate in these inspections.
Following processes are carried out in microbiology laboratory:

Sterility Testing

Antimicrobial Efficacy Testing (AET)

Microbial Limits Testing

Bioburden Determination

Endotoxin (LAL) Testing

Environmental Monitoring and Identification

Water Analysis

MICROBIOLOGICAL TESTING OF NON-STERILE PRODUCTS


For a variety of reasons, we have seen a number of problems associated with the
microbiological contamination of topical drug products, nasal solutions and inhalation products.
The USP Microbiological Attributes Chapter <1111> provides little specific guidance other than
"The significance of microorganisms in non-sterile pharmaceutical products should be evaluated
in terms of the use of the product, the nature of the product, and the potential hazard to the user."
The USP recommends that certain categories be routinely tested for total counts and specified
indicator microbial contaminants. For example natural plant, animal and some mineral products
for Salmonella, oral liquids for E. Coli, topical for P. aeruginosa and S. Aureus, and articles
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intended for rectal, urethral, or vaginal administration for yeasts and molds. A number of specific
monographs also include definitive microbial limits
Microbiological testing may include an identification of colonies found during the Total
Aerobic Plate Count test. Again, the identification should not merely be limited to the USP
indicator organisms. The importance of identifying all isolates from either or both Total Plate
Count testing and enrichment testing will depend upon the product and its intended use.
Obviously, if an oral solid dosage form such as a tablet is tested, it may be acceptable to identify
isolates when testing shows high levels. However, for other products such as topical, inhalants or
nasal solutions where there is a major concern for microbiological contamination, isolates from
plate counts, as well as enrichment testing, should be identified.
STERILITY TESTING
One of the most important aspects of the inspection of a sterility analytical program is to
review records of initial positive sterility test results. Request lists of test failures to facilitate
review of production and control records and investigation reports. Particularly, for the high risk
aseptically filled product, initial positive sterility test results and investigations should be
reviewed. It is difficult for the manufacturer to justify the release of a product filled aseptically
that fails an initial sterility test without identifying specific problems associated with the controls
used for the sterility test.
Examine the use of negative controls. They are particularly important to a high quality
sterility test. Good practice for such testing includes the use of known terminally sterilized or
irradiated samples as a system control. Alternatively, vials or ampules filled during media fills
have also been used.Be especially concerned about the case where a manufacturer of aseptically
filled products has never found an initial positive sterility test. While such situations may occur,
they are rare. In one case, a manufacturer's records showed that they had never found a positive
result; their records had been falsified. Also, the absence of initial positives may indicate that the
test has not been validated to demonstrate that there is no carryover of inhibition from the
product or preservative.
VALIDATION
Confirmation, through the provision of objective evidence, that the requirements for a
specific intended use or application have been fulfilled.
Validation is one of the important steps in achieving and maintaining the quality of the
final product. If each step of production process is validated we can assure that the final product
is of the best quality. Validation of the individual steps of the processes is called the process
validation. Different dosage forms have different validation protocols
PROCESS VALIDATION: Process Validation is establishing documented evidence which

provides a high degree of assurance that a specific process will consistently produce a product
meeting its pre-determined specifications and quality characteristics.

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Types of process validation:
1) Prospective validation
2) Retrospective validation
3) Concurrent validation
4) Revalidation

Instruments and Devices seen in Microbiology Laboratory

Analytical balance
Incubator
Refrigerator
Biosafety cabinet / Laminar Air Flow
Magnetic stirrer
Deef freezer
Light microscope
PH meter
Autoclave
Hot air oven

Analytical Balance
They are used in precise weighing of small amounts (upto miligrams) of samples and chemicals
used for preparing media and stock solutions.
Biosafety Cabinet
It is used in microbial inoculation and isolation studies as well as sterile storage of materials. In
addition, it is utilized for protection of user, samples and the environment from hazardous
contamination.
Refrigerator
The device is used for the storage of the stock solutions, chemicals, kits and nutrient media that
should be maintained at certain temperatures.
Shaker Incubator
In the microbiology laboratories it is among the leading devices which are based on the principle
of shaking at different temperatures according to the purpose and the work load of the laboratory.
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It is used in cultivating, multiplying and in the characterization tests of microorganisms. This
device provides the heat necessary for the growth of microorganisms.
Deep Freezer
It is used to store stock cultures in microbiology. It is a device used to store materials which
should be kept at low temperatures (cells, tissues, enzymes, proteins, etc.)

Inverted Phase Contrast Light Microscope


Inverted Phase Contrast Light Micros By the help of different refractive properties of the light,
Phase Contrast Light Microscope provides visibility to subcellular structures of microorganisms
that are examined in a liquid medium without any staining. Fluorescence attachment is used to
display objects stained with special fluorescent dyes (DAPI, FITC, Texas Red Etc.) and that
cannot be displayed with normal light microscopy techniques. It operates according to the
principle of reflective light.
Magnetic Stirrer
Magnetic stirrer is a device which provides mixing and keeping the chemical solutions and
mixtures at a certain time and temperature by the help of a magnetic bar. Vortex agitates the
solutions in the tube, flask and so on in certain speed and duration.
Incubator
In the microbiology laboratories it is among the leading devices which work at different
temperatures according to the purpose and the work load of the laboratory. It is used in
cultivating, multiplying and in the characterization tests of microorganisms. This device provides
the heat necessary for the growth of microorganisms.
PH meter
It is used to determine the pH of the media prior to experiments and to monitor pH value during
experiments. The device is used especially in the preparation of stock solutions and the culture
media used for the growth of microorganisms.
Autoclave
The main purpose of this device is to sterilize materials and media under pressure and steam.

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ENGINEERING SECTION

Electricity unit
Water treatment system
Water softening unit
Chilling/ steam unit
Air Handling Unit (AHU)
Effluent Treatment Plant

ELECTRICITY UNIT:

Generation of electricity in cadila is from three sub-station red, yellow and blue (RYB)
Light arrester: -A lightning arrester is a device used on electrical power systems and
systems to protect the insulation and conductors of the system from the damaging effects
of lightning. The typical lightning arrester has a high-voltage terminal and a ground
terminal.
Transformer:-Step-down unit, this transformer converts high-voltage, low-current
power into low-voltage, high-current power. The larger-gauge wire used in the secondary
winding is necessary due to the increase in current. The primary winding, which doesnt
have to conduct as much current, may be made of smaller-gauge wire.
Cadila has two step-down transformers, one which convert voltage from 66kv to
11kv and the other one which convert the voltage from 11kv to 440 volt for the industrial
use.
Vacuum
Circuit
Breaker:-A circuit
breaker is
an
automatically
operated electrical switch designed to protect an electrical circuit from damage caused
by over current or overload or short circuit. Its basic function is to interrupt current flow
after protective relays detect a fault.

WATER TREATMENT SYSTEM:

Water treatment is used to optimize most water-based industrial processes, such as:
heating, cooling, processing, cleaning, and rinsing so that operating costs and risks are reduced.
Poor water treatment lets water interact with the surfaces of pipes and vessels which contain it.
Steam boilers can scale up or corrode, and these deposits will mean more fuel is needed to heat
the same amount of water. Cooling towers can also scale up and corrode, but left untreated, the
warm, dirty water they can contain will encourage bacteria to grow, and Legionnaires Disease
can be the fatal consequence. Also, water treatment is used to improve the quality of water
contacting the manufactured product e.g. semiconductors, and/or can be part of the product e.g.
beverages, pharmaceuticals, etc. In these instances, poor water treatment can cause defective
products. Domestic water can become unsafe to drink if proper hygiene measures are neglected.

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Water softening: - Water softening is the removal of calcium, magnesium, and certain
other metal cat ionsin hard water. The resulting soft water is more compatible with soap
and extends the lifetime of plumbing. Water softening is usually achieved using lime
softening or ion-exchange resins.
Chilling/Steam unit:
Chiller
A chiller is a machine that removes heat from a liquid via a vaporcompressionor absorption refrigeration cycle. This liquid can then be circulated
through a heat exchanger to cool equipment, or another process stream (such as
air or process water). As a necessary byproduct, refrigeration creates waste heat
that must be exhausted to ambient or, for greater efficiency, recovered for heating
purposes. Concerns in design and selection of chillers include performance,
efficiency, maintenance, and product life cycle environmental impact. In
industrial application, chilled water or other liquid from the chiller is pumped
through process or laboratory equipment. Industrial chillers are used for
controlled cooling of products, mechanisms and factory machinery in a wide
range of industries.
Boiler
A boiler or steam generator is a device used to create steam by
applying heat energy to water. A boiler or steam generator is used wherever a
source of steam is required. The form and size depends on the application:
mobile steam engines such as steam locomotives, portable engines and steampowered road vehicles typically use a smaller boiler that forms an integral part of
the vehicle; stationary steam engines, industrial installations and power stations
will usually have a larger separate steam generating facility connected to the
point-of-use by piping.

AIR HANDLING UNIT (AHU)


An Air Handling Unit (most of the times abbreviated to AHU), or Air Handler, is a central air
conditioner station that handles the air that, usually, will be supplied into the buildings by the
ventilation ductwork (connected to the AHU).Handling the air means that the air will be
delivered into the building spaces with thermo-hygrometric and IAQ (Indoor Air Quality)
treatment. The accuracy of the treatment will depend from the specificity of each project,). This
means, the Air Handling Unit treat the air by filtering, cooling and/or heating, humidifying
and/or dehumidifying.
EFFLUENT TREATMENT PLANT (ETP)
Industries use water that obtained from the water treatment system for a variety of purposes, such
as for manufacturing goods, heating, cooling, carrier of raw material, carrier of waste matter, as a
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solvent etc. The resulting water is then classified as a wastewater.The indiscriminate discharge of
these wastewater streams into the environment can
- Render soils "sick ".
- Pollute the receiving bodies of water.
- Cause air pollution by generating obnoxious gases
To prevent any health hazards caused by discharging wastewater into the environment and
protect domestic sewage, the wastewater must be treated before discharge.
Screening
The first unit operation encountered in wastewater-treatment plants is screening. A screen is a
device with openings, generally of uniform size that is used to retain the coarse solids found in
wastewater. According to the size of openings, screens are designated as coarse or fine. Coarse
screens have openings of inch or more, and fine screens have openings of less than inch.

Oil Separation
It is a process in which Floatables, namely non-emulsified oil and organics separates from
wastewater. The design of the separator is based on the specific gravity difference between the
oil and the wastewater and between the suspended solids and wastewater. In general, this
separator can handle very large flow. However, its disadvantage is the long retention time
required for efficient oil separation.
Flow Equalization
Flow equalization is used to overcome the operational problems caused by flow variations, to
improve the performance of the downstream processes, and is also used as an emergency tank to
equalize wastewater effluent in case of any process failure in the treatment process.The design
must provide for sufficient mixing to prevent solids deposition and concentration variations and
also to provide aeration to prevent odor problems.

Sedimentation
Sedimentation is the separation from water, by gravitational settling, of suspended particles
that are heavier than water.Sedimentation is used for separation of grit and particulate matter in
the primary settling basin, separation of biological-floc in the activated-sludge settling basin, and
separation of chemical-floc when the chemical coagulation process is used. It is also used for
solids concentration in sludge thickeners.
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Neutralization
Industrial wastes often contain acidic or alkaline components which require neutralization
before discharge or treatment. For wastes that are discharged to receiving waters, a pH between 6
and 9 is frequently specified by regulatory agencies. For wastes entering biological treatment
processes, the pH should be maintained between 6.5 and 9 for optimum growth of the
microorganisms.
Acidic wastes are commonly neutralized with waste alkaline streams, lime, dolomite,
ammonia, caustic soda, or soda ash.Lime is the most widely used alkaline material for
neutralization acid wastes because of its low cost. Lime may be slow to react and may form
insoluble precipitates.Alkaline wastes usually require treatment with a waste acidic stream,
sulfuric acid or hydrochloric acid.
Activated Sludge
The conventional activated sludge system contains a tank for wastewater aeration followed by
a settler and solids recycle line.The wastewater flows through under constant aeration in the
presence of activated sludge and exits at the end of the tank after 4-8 hours of residence time.
The oxygen concentration in the reactor should be 0.5-2 mg/l throughout, where values over 2
mg/l are considered lost energy.
Extended Aeration is the modified form of a conventional activated sludge process in which
the production of excess sludge is minimized by oxidation and an increase in residence time, i.e.
through the larger size of the aeration tank.The retention time is extended to 1-2 days, which
results in a very low net yield of sludge due to its consumption of endogenous respiration.

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RAW MATERIAL AND FINISHED GOODS SECTION
RAW MATERIALS
A raw material, also known as a feedstock or most correctly unprocessed material, is a basic
material that is used to produce goods, finished products, energy, or intermediate materials which
are feedstock for future finished products. As feedstock, the term connotes these materials are
bottleneck assets and are highly important with regards to producing other products.
Pharmaceutical raw materials comprise substrates or elements that are used for manufacturing
different types of drugs e.g. endocrine disorder drugs, musculoskeletal system drugs, antiinfective drugs viz. cephalexin, penicillin, ampicillin, cephradine, etc. Pharmaceutical excipients
and ingredients or raw materials used to manufacture drugs are extracted from different types of
sources. These sources could be natural or synthetic. Recently, many of the raw materials
previously derived from natural sources are being produced synthetically in part or even biotechnologically. This is so because manufacturing them artificially is economical, safer, and
much quicker. Pharmaceutical raw materials are manufactured using different types of acids,
alcohols,
esters,
phenones,
pyridines,
etc.
Pharmaceutical raw materials are essential to producing pharmaceutical drugs and include
active pharmaceutical ingredients (API), also known as bulk active, are pharmaceutically active,
and have the desired pharmacological effects on the body e.g. alvimopan, sparfloxacin,
sapropterindihydrochloride, lanreotideacetate,nicotinic acid, etc. In contrast pharmaceutical
excipients are the pharmaceutically inert substances which help in delivering the active
ingredient, e.g. antiadherents, binders, coatings, disintegrants, fillers, etc.
STEPS INVOLVE IN RAW MATERIAL WAREHOUSE

receiving
sampling
storing
dispensing

RECEIVING
raw material is supplied by vendors by placing order
after receiving the raw material check the observation on pack
segregate the raw material according to batch number
pre entry cleaning of raw material by vacuum cleaner
weighing of the raw material
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SAMPLING
before sampling get line clearance by QA person
QC person test the sample of raw material under LAF by different tests and fill it in
observation on sampling area &pack and certificate of analysis
warehouse operators will paste the labels of approvedlabel and sampledlabel
next sent raw material for storing
STORING
the raw material is stored at 3 different temperature zones

Ambient: not more than 35 c


Controlled temperature room: 15 to 25 c
Cold room: 2 to 8 c

Temperaturepoint:
It is the point where the temperature is checked by placing digital thermometer on daily basis
DISPENSING
Raw material is picked for dispensing according to materialpicklist for process order
and dispensed according to BMR prepared by QA personnel
Selection of raw material is done according to firstexpiryfirstdispense
Raw material is dispensed from dispensing booth under LAF to the production area
FINISHED GOODS
Finished goods are goods that have completed the manufacturing process but have not
yet been sold or distributed to the end user. A good purchased as a "raw material" goes into the
manufacture of a product. A good only partially completed during the manufacturing process is
called "work in process". When the good is completed as to manufacturing but not yet sold or
distributed to the end-user, it is called a "finished good". This is the last stage for the processing
of goods. The goods are ready to be consumed or distributed. There is no processing required in
term of the goods after this stage by the seller.

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PROCEDURE

Receive the finished good transfer ticket from production duly authorized by
production supervisor and checked by QA

Following are to be made in finished good transfer ticket after received from
production
Name of product
Batch No.
Manufacturing date
Expiry date
Quantity (No of box x per pack)
Date of transfer tickets

Verify the received goods against transfer with above details

Ensure the all details are complete as per out requirement

In case of any observation, intimate to production department and get it corrected

Enter the physically verified quantity in SAP system.

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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
toclarify my theoretical knowledge. I hope and pray that it will help me much in my future
profession.
During our training period, we had seen 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. And the same guideline was seen followed in Cadila Pharmaceutical
Limited (J&k). It helped us to acquire knowledge on punctuality, regularity and working
environments in industries.
Training in cadila reshape my mind in different sectors based on education,
communication and interactions, zero determination of error, commercialization and many more.

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BIBLIOGRAPHY
Cadilapharma.com

Wikipedia

www.slideshare.net

GPAT Cracker

Standard Operating Procedure Records (SOPs)

Batch Manufacturing Records (BMRs)

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